Can You Drink Alcohol After Getting The COVID Vaccine?

Can You Drink Alcohol After Getting The COVID Vaccine?

  • April 9, 2021

Let’s say you’ve done everything that’s been asked of you. You paid attention to the information regarding availability of the COVID-19 vaccine, made your appointment, and got the shots. Can you celebrate with a beer, cocktail, or glass of wine?

Looking through the Centers For Disease Control and Prevention (CDC) guidelines, they’ve got recommendations for painkillers, in which they say you should avoid taking OTC pain meds, like ibuprofen and Tylenol if you’re hoping that they’ll somehow blunt the potential side-effects of the vaccine. The CDC does say that it’s perfectly fine to take those pain meds post-vaccination, though.

When it comes to beer, wine, and hard liquor, there’s not a lot to find at the CDC website about how it will affect the COVID-19 vaccine’s overall effectiveness. However, The National Institutes of Health (NIH) website says that your immune system can be negatively effected by excessive alcohol consumption, but the study was not done with the COVID-19 vaccine in mind. The NIH study points out that excessive consumption of alcohol can cause multiple problems like:

“acute respiratory stress syndromes (ARDS), sepsis, alcoholic liver disease (ALD), and certain cancers; a higher incidence of postoperative complications; and slower and less complete recovery from infection and physical trauma, including poor wound healing.”

Okay, excessive drinking isn’t good for you at all, we get it. But will having a drink or two after being vaccinated cause you big problems? It turns out the answer is actually no. Health.com says it’s not going to help you feel any better, either.

They put the alcohol-after-vaccination question to some infectious disease experts, and while the experts wouldn’t recommend having cocktail hour right after you get your final shot, it’s not something they’re particularly worried about. The biggest objections to you having that celebratory libation breaks down to how it will make you feel.

Health.com:

“Vaccine side effects include muscle aches and pains and feeling under the weather. Compounding that with the side effects of alcohol runs the risk of making you feel worse,” Tania Elliott, MD, clinical instructor of medicine at NYU Langone Health.

Another doctor speculated that someone could confuse a hangover with side-effects of the COVID-19 vaccine, potentially frightening off others who had planned on receiving the shots.

 

KEEP READING: See 25 natural ways to boost your immune system

Can you mix and match Covid-19 vaccines?

Can you mix and match Covid-19 vaccines?

  • April 7, 2021

With delays in global production and distribution, mixing two doses of vaccines may end up becoming inevitable. But questions concerning its safety and efficacy remain unanswered.

As Covid-19 vaccine rollouts continue across the globe, people are being administered two-doses: a ‘prime’ first dose, followed by a ‘boost’ second dose some weeks later.

Thirteen vaccines are currently in use against the virus and an additional 67 are in clinical development around the world, with nearly two-thirds designed to generate immunity with two or more doses.

But with supply scarcity and distribution of certain vaccines an ongoing issue and many hunting for leftovers, a question is starting to cross people’s minds: what happens if you get two different vaccine doses? What if you were to pair a first dose of the AstraZeneca vaccine with a second dose supplied by Moderna?

And, most importantly, would it be safe?

It could be possible that greater immunity is generated if different vaccines are used one after the other, in what is known as “heterologous prime boosting”.

Both the Pfizer and AstraZeneca vaccines prime the immune system to target the coronavirus’ spike protein, which plays an instrumental role in the infection process.

But they hone in on different parts of the spike and deliver their payloads by two different means. Pfizer hands over genetic instructions for making the spike protein and relies on human cells to produce it, while AstraZeneca uses a modified cold virus to present the spike protein to the immune system.

Moderna also uses the same mRNA platform that Pfizer does.

“We’re not sure why a mix-and-match approach can be more potent. But it’s possible combining two different vaccines – which give the same antigen target but stimulate the immune system in different ways – could better focus our immune cells’ attention on the right target,” wrote Dr Kylie Quinn, a Vice-Chancellor’s Research Fellow at the School of Health and Biomedical Sciences at RMIT University.

COVID-19 vaccines from AstraZeneca, Moderna and Pfizer-BioNTech are stored at a vaccination centre in the district of Harz in Quedlinburg, Germany.
COVID-19 vaccines from AstraZeneca, Moderna and Pfizer-BioNTech are stored at a vaccination centre in the district of Harz in Quedlinburg, Germany.
(Matthias Bein / DPA via AP)

According to the Centers for Disease Control and Prevention (CDC) in the US, while more research is needed on the subject, there should be no side effects to mixing. The CDC maintains that medical professionals administering vaccinations should do their best to ensure patients receive two of the same shots if they’re administering the Pfizer or Moderna vaccine.

However, in an “exceptional situation” where a second shot of the first vaccine type isn’t available, “any available mRNA Covid-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA Covid-19 vaccination series.”

Dr Bulent Sekerel, Director of Hacettepe University’s Faculty of Medicine, is skeptical about mixing and matching until there is clear scientific backing.

“As far as I know neither of these protocols have been evaluated in clinical trials. We need to have evidence to discuss it with the public or suggest it as a treatment alternative,” he told TRT World.

TRT World reached out to BioNTech and AstraZeneca for comment, but both declined until conclusive studies on vaccine mixing were available. Other experts were also reluctant to discuss it until evidence from trials emerged.

For the moment, experiments in mice have shown promising results, in which combinations of the Pfizer and AstraZeneca vaccines boosted immunity better than two doses on their own.

But there is no evidence that it works in humans – at least, not as of yet.

Significance of the UK’s mix-and-match trial

As of last month, Oxford University has begun conducting a clinical trial to test whether it’s safe to mix vaccination types after the UK government gave medical professionals the go ahead to mix shots in January.

The trial, referred to as the Covid-19 Heterologous Prime Boost study or ‘Com-Cov’ study, will recruit over 800 volunteers aged 50 and above. Using an eight-armed clinical trial, it will evaluate the four different combinations of prime and booster vaccinations: volunteers will either receive one dose of the Pfizer vaccine followed by one dose of the AstraZeneca vaccine, the reverse, or two regular doses of each vaccine type.

Volunteers will then be evaluated at two different dosing schedules: a four-week interval for early interim data and a twelve-week interval. Using blood samples, the study will monitor the impact of different dosing regimens on participant’s immune responses.

Overall, the study will last for thirteen months.

“As we roll out vaccination in the UK, we have the opportunity to look at how to get the most out of the vaccines available to us. This innovative study looks at whether using different combinations of two currently approved vaccines is a good alternative to the standard schedule. We will also be looking at the impact of the interval between doses on immune responses,” Dr Maheshi Ramasamy, Senior Clinical Researcher and Investigator on the trial, said in a statement.

If the results are positive, it could help ease supply chain issues and help boost a more robust immune response in recipients.

Professor Jonathan Van-Tam, Deputy Chief Medical Officer and Senior Responsible Officer for the study, said: “Given the inevitable challenges of immunising large numbers of the population against COVID-19 and potential global supply constraints, there are definite advantages to having data that could support a more flexible immunization programme, if needed and if approved by the medicines regulator.”

“It is also even possible that by combining vaccines, the immune response could be enhanced giving even higher antibody levels that last longer; unless this is evaluated in a clinical trial we just won’t know.”

A nurse administers the Pfizer-BioNTech Covid-19 vaccine to a person at a hospital, in Ankara, Turkey, on April 3, 2021.
A nurse administers the Pfizer-BioNTech Covid-19 vaccine to a person at a hospital, in Ankara, Turkey, on April 3, 2021.
(Burhan Ozbilici / AP)

New strains in South Africa for example, underscore the importance of having an immunisation strategy that preserves or improves vaccine-induced immunity as novel variants of the virus emerge.

There is also precedent for combining vaccines that use different vehicles to deliver their payloads. Two doses of Russia’s Sputnik V vaccine use two kinds of viruses to transport the genetic instructions that tell the immune system which coronavirus surface proteins to look for.

In clinical trials, research revealed that Sputnik V had an efficacy of 91.6 percent and is now in use in Russia and 56 other countries.

Russia’s Gamaleya Research Institute, which designed Sputnik V, took a similar approach to formulating the first and second doses of its Ebola vaccine. Several experimental HIV vaccines are being tested using the same approach too.

Recently, Gamaleya and AstraZeneca have teamed up to register a pair of clinical trials – one in Azerbaijan and the other in Russia – to see how well their vaccines work in tandem.

But the problem with testing the safety of mixing vaccine combinations is ultimately compounded by the complexity of immunity itself.

“What we know to measure is only half the story,” said Dr Gregory Poland, a vaccine researcher at the Mayo Clinic in Minnesota. While the British trial will measure the antibodies in the bloodstream, it’s not clear if immunity can be achieved through neutralising antibodies alone.

“If you alter one component of that, you no longer know if you have the same efficacy and safety,” said Poland.

But in the midst of a global pandemic that level of caution might be a luxury – and mixing vaccines may end up being inevitable.

Source: TRT World

Governments+are+distributing+COVID-19+vaccines+worldwide%2C+helping+more+people+build+immunity+to+the+virus.

Scot Scoop News | Three COVID-19 vaccines build immunity

  • April 7, 2021

Despite the vaccine developments, the pandemic is far from over, with coronavirus variants appearing in various countries. 

“The variants are to be expected because that’s what viruses do,” Brainard said. “Viruses survive by changing themselves, and they change themselves so that they can avoid the body’s immune system.”

To combat those mutations, companies are looking at various strategies. Especially with mRNA, it is easier to modify the vaccine to carry the new virus sequence, which would signal the immune system to produce a different antibody. 

“There’s active research into how effective the current vaccines are against the variants and whether or not a booster shot designed to target those variants and provide a broader protection would be necessary,” Brainard said.

The ongoing research will be crucial in determining future steps. 

“Because the COVID-19 infection outcome is much much worse, the worst-case scenario is if the SARS-CoV-2 continues and we need to get a vaccine every year,” Wang said. “Both Pfizer and Moderna are working on follow-up booster doses for vaccines against virus mutations. If the virus keeps on circulating, if we don’t have herd immunity, if people don’t get the vaccine, there might be even more mutations.”

Even so, herd immunity in one country will not help.

It’s a competition between human beings’ immunity and virus evolution.”

— Jing Jin

“Now it’s just a competition between human beings’ immunity and virus evolution. If you look at the data nationally, the cases are rising, and this is under the condition with parts of the population already fully vaccinated,” Jin said. “If other countries cannot control the variants, eventually the U.S. will also have new problems. With the new variants circulating, it’s very hard to predict what will happen, but it will not end very soon.”

However, the world is, undoubtedly, a step closer to returning to normal as companies and the government are doing their best to make the vaccines more available. 

Carly Ramirez, a senior who works in food service, has recently gotten her first Pfizer vaccine. She is hopeful that the vaccine will be vital in ending the pandemic by creating immunity. 

“I’ve always had trust in the vaccines. I know a lot of people are worried about how fast the vaccines were developed or if they got the right amount of testing or if side effects are fatal,” Ramirez said. “A lot of people say they want to wait for a better one, but I totally disagree with that. I’d rather risk getting the vaccine than getting the coronavirus itself.”

There is no telling how long the pandemic will last, but people can do their part to stay safe by taking any protection measures available. 

“Vaccines are the most powerful weapon humans have against infectious diseases. Unfortunately, nobody will 100% guarantee that you will be protected, even if you get the two doses for Pfizer or Moderna because the immune response is different for each individual,” Wang said. “Whether you have the vaccine or not, we are still recommended to take universal precautions to protect yourself and protect others.”

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Combining PD-1/PD-L1 Inhibitors and HPV Vaccines Holds Promise in HNSCC

Combining PD-1/PD-L1 Inhibitors and HPV Vaccines Holds Promise in HNSCC

  • April 5, 2021

Research on combination therapies involving human papillomavirus (HPV)-targeted vaccines and immunotherapies continues to expand in phase 2 and 3 trials in patients with head and neck squamous cell carcinoma (HNSCC). HPV-associated tumors, particularly HPV-16–positive cancers, represent a biologically distinct subgroup of HNSCC.1 These tumors exhibit distinct immune characteristics and a different tumor microenvironment compared with HPV-negative tumors. Patients with HPV-positive HNSCC have a better prognosis and dramatically improved 5-year survival (~70%) compared with their HPV-negative counterparts (~40%-50%).1,2 Patients with HPV-positive cancers present 13 years earlier at diagnosis and live longer lives. However, treatment for both HPV-related and -unrelated cancer subtypes has largely remained the same. In a step toward precision medicine, investigators are now examining ways to exploit the specific immune properties of HPV-positive tumors to target the viral origin of the disease.

The mainstay of first-line treatment for advanced HNSCC consists of surgery followed by radiotherapy with or without platinum-based chemotherapy in combination with cetuximab (Erbitux).3 Given the high survival rate in HPV-positive HNSCC, efforts have been made to deintensify treatment to reduce toxicities and the resulting comorbidities and their negative impact on patients’ quality of life.2,3 Pembrolizumab (Keytruda) and nivolumab (Opdivo) were recently approved for recurrent and/or metastatic oropharyngeal cancers (OPCs) in patients progressing on or after platinum-based chemotherapy.2,3 Pembrolizumab, in combination with platinum-based chemotherapy and 5-fluorouracil, is approved for the first-line treatment of all patients with recurrent and/or metastatic HNSCC and as monotherapy in patients whose tumors express PD-L1 with a combined positive score of 1 or more.2,3

Not withstanding the good prognosis seen with HPV-associated HNSCCs, approximately one-third of patients with this cancer subtype will develop metastatic disease and die. No targeted therapies have been developed or approved for those in the HPV-positive HNSCC subset.4 “Despite its different biology, disease characteristics, and behavior, and its viral underlying cause, HPV-associated cancer continues to be treated with the same aggressive chemoradiotherapy regimens traditionally used for HPV-negative cancers,” said Robert L. Ferris, MD, PhD, director of UPMC Hillman Cancer Center at the University of Pittsburgh in Pennsylvania, during an interview with Targeted Therapies in Oncology. “With improved survival comes increased toxicities [and] permanent treatment-related morbidities in a younger population [of patients who have] a longer lifespan [and have] overwhelmed survivorship clinics. These factors have important considerations for society and the health systems that [treat] these patients.” An important unmet medical need exists for safe and effective treatments in this population.

Single-agent PD-1 immunotherapy, however, has demonstrated durable clinical responses and survival in a small number of patients (~20%) with advanced HNSCC.4 Investigational HPV-16–targeted vaccination induced a strong immune response, but was not effective alone at treating advanced cancers.4 Emerging strategies include combinations of PD-1/PD-L1 inhibitors with therapeutic HPV vaccines targeting non–self-antigens to activate the immune system against the tumor.5 This article explores the clinical benefits of therapeutic HPV vaccines in HPV-associated HNSCCs and the ongoing clinical trials combining HPV-targeted vaccines with immunotherapies.

Tumor Microenvironment in Head and Neck Cancers

The tumor microenvironment in advanced HNSCC is highly immunosuppressive and characterized by T-cell dysfunction, low levels of CD4- and CD8-positive T cells, increased regulatory T cells (Tregs), and disrupted antigen presentation.5 T-effector (Teff) and natural killer (NK) cells are responsible for tumor attack, whereas Tregs mediate tumor cell growth and immune suppression. HPV-positive tumors have greater levels of tumor-infiltrating lymphocytes (TILs), such as T, B, and NK cells, compared with HPV-negative tumors, and patients whose HPV-positive tumors have higher TIL levels have better out-comes than those with lower TIL levels. Within this microenvironment, outcomes also depend on the balance between levels of tumor-directed Teff cells and immunosuppressive Tregs in the TIL population.2

Therapeutic HPV Vaccination in Combination with PD-1/-L1 Immunotherapy

HPV-positive OPCs, particularly advanced cancers, develop adaptive immune evasion mechanisms through the upregulation of PD-1/PD-L1 check-points. This attenuates CD4-positive T-cell cytotoxic activity, decreases myeloid-derived suppressor cell numbers, and acts through other mechanisms. A strong rationale exists for the use of PD-1/PD-L1 inhibitors to improve efficacy and reduce toxicities during deintensification approaches.2,4,6,7

The FDA has approved prophylactic HPV vaccines for the prevention of gynecological and oropharyngeal cancers caused by infections with high-risk HPV types, including HPV-16.8,9 These vaccines stimulate the production of neutralizing antibodies and prevent HPV-associated cancers but do not target viral antigens expressed during the tumorigenic process in HPV-positive cancers.

Viral proteins are considered foreign to the immune system, or non–self-antigens, and represent ideal targets for therapeutic vaccination. HPV viral proteins E6 and E7 are the main oncogenes expressed in HPV-positive cancers that drive oncogenesis and maintain HPV-associated disease.2,5,6,10 Vaccines targeting the E6 or E7 antigens have shown efficacy in HPV-induced cervical dysplasia and investigators are now testing them in head and neck cancers.11,12 They are also evaluating the E5 HPV viral oncogene in preclinical studies, which is thought to cooperate with E6 or E7 in tumorigenesis.10,11

HPV-specific immunotherapy through targeted therapeutic vaccines triggers strong immune responses and tumor infiltration by HPV-specific T cells2; however, HPV-16–targeted vaccination alone has been ineffective in treating recurrent advanced HPV-positive cancers. An emerging area of interest is the use of HPV antigen–targeted vaccination to stimulate a proinflammatory immune response in combination with PD-1/PD-L1 immune checkpoint inhibitors to enhance the effect of these agents. The combination may increase the number of patients who respond to therapy and thus may improve outcomes in HPV-associated HNSCC.5,11

Unique Combinations: Vaccines and PD-1/PD-L1 Inhibitors

TG4001

Positive results of a phase 1b/2 trial (NCT03260023) of the investigational therapeutic vaccine TG4001 (tipapkinogene sovacivec) plus avelumab (Bavencio) were recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Patients (n=34) with previously treated recurrent and/or metastatic HPV-16–positive cancers received TG4001, an HPV-16E6/E7–targeted vaccine, in combination with avelumab.13,14

The overall response rate (ORR) was 23.5% in all evaluable patients, including 7 partial responses and 1 complete response; the latter was durable. Trial investigators observed markedly different ORRs in patients with liver metastases (0%; n=11) and in those without (34.8%; n=23; TABLE).13 Treatment induced an HPV-16 E6/E7–specific T-cell response and favorable changes in the tumor microenvironment, including increases in TILs and the expression of genes related to immune system activation. The authors concluded that a larger, randomized clinical trial was warranted to confirm these findings.13,14

ISA101

In a phase 2 study, investigators examined whether the HPV-16 vaccine ISA101 could augment the efficacy of the PD-1 inhibitor nivolumab in advanced HPV-positive tumors. ISA101 triggers CD4/CD8-positiveT-cell responses and has shown efficacy in advanced gynecological cancer.7,15 Enrolled patients (n=24) had incurable HPV-16–positive gynecological and oropharyngeal tumors, of which 22 were OPCs.

Eight of the 22 patients with OPC (36% ORR) met the primary end point of overall survival (OS) compared with the 16% ORR seen with nivolumab alone in HPV-positive patients in CheckMate-141 (NCT02105636).5 Five of 8 patients (63%) had durable responses, and the OS rate was 70% (FIGURE5). Patients toleratedthe combination of ISA101 and nivolumab well. The median OS of 17.5 months with the combination was approximately double that seen with pembrolizumab or nivolumabin subsets of patients who were HPV-16 positive.4,7,16 The study results supported the rationale that using PD-1 inhibitors to block tumor-induced immunosuppression would potentiate the cytotoxic effects of the vaccine and that HPV-16 vaccination would augment the efficacy of PD-1 inhibitors in incurable HPV-16–positive cancer. Further studies with larger numbers of patients are needed to validate this combination.17

MEDI0457

The safety and efficacy of a novel HPV-16/HPV-18–targeted DNA immunotherapy was tested in a phase 1b/2 open-label study (NCT03162224). MEDI0457 was evaluated in 22 patients with locally advanced HPV-16/HPV-18–positive HNSCC.5,11,18,19

In an earlier phase 1 pilot study (NCT00685412), women with HPV-16/HPV-18–positive high-grade cervical intraepithelial neoplasia received VGX-3100 alone, which induced E6/E7-specific immune responses and a 50% rate of tumor regression.20 With the addition of recombinant cytokine IL-12 to this HPV DNA vaccine, MEDI0457 is anticipated to boost immune responses by increasing Teff cells and overcoming HPV-driven immune evasion.5,12 VGX-3100 is now in phase 3 trials for the treatment of precancerous cervical, vulvar, and anal lesions.

In the phase 1b/2 trial mentioned above, MEDI0457induced HPV antigen-specific CD8-positive T-cell activity, generated immune infiltration of tumor tissue, and shifted the composition of TILs in the tumor microenvironment toward a proinflammatory state.5 In this trial, MEDI0457 induced persistent peripheral and tumor responses lasting up to 23 months in patients with HPV-16–positive locally advanced HNSCC, including those who had recently received concurrent chemoradiotherapy. The results of this study demonstrate the value of therapeutic HPV vaccines as a complementary strategy to PD-1/PD-L1 inhibition to improve therapeutic outcomes in HPV-associated HNSCC.5

Investigators are now evaluating MEDI0457 in combination with durvalumab(Imfinzi) in a phase 1b/2a study (NCT03162224) in 35 patients with HPV-associated recurrent or metastatic HNSCC.

JAVELIN Head and Neck 100

Interim phase 3 results of JAVELIN HEAD AND NECK 100 (NCT02952586), presented at ESMO 2020, showed that first-line treatment with avelumab plus chemoradiotherapy failed to improve progression-free survival (PFS) in patients with locally advanced HNSCC.21 The trial evaluated avelumab in patients (n=697) with histologically confirmed HNSCC who were eligible to receive chemoradiotherapy with curative intent. The PD-L1 inhibitor avelumab was added to standard high-dose chemotherapy to evaluate the impact on PFS. The trial was terminated prematurely because the futility boundary had been crossed.

Patients were randomized 1:1 (n=697) to receive avelumab 10 mg/kg every 2 weeks plus cisplatin 100 mg/m2 every 3 weeks and 7 weeks of radiotherapy at 70 Gy, followed by avelumab maintenance. In the control arm, avelumab was replaced with placebo.21 Median PFS and OS were not reached in either arm. The hazard ratio for PFS was 1.21 (95% CI, 0.93-1.57, P=.920) based on 224 events, and the hazard ratio for OS was 1.31 (95% CI, 0.93 -1.85; P=.937) based on 131 deaths.21

Nabil F. Saba, MD, director of the Head and Neck Medical Oncology Program at Winship Cancer Institute of Emory University in Atlanta, Georgia, pointed out that high doses of radiotherapy (70 Gy) with chemotherapy are highly toxic and may severely damage the activity of Teff cells and impair immune response modulation.

“Results of the JAVELIN trial,” he added, “must prompt us to evaluate the appropriate intensity of chemoradiotherapy that patients receive and the possibility that lower doses or less frequent schedules of radiotherapy may preserve immunomodulatory Teff-cell function.”

UCPVax

Telomerase reverse transcriptase is over-expressed in most cancer cells and plays a major role in cellular proliferation. UCPVax is a therapeutic vaccine containing telomerase-derived cancer peptides and induces a CD4-positive T-helper immune response against telomerase-expressing cells. The phase 2 VolATIL trial (NCT03946358) is evaluating the efficacy of UCPVax in combination with atezolizumab (Tecentriq) in previously treated patients who are HPV positive.

PD-1/PD-L1 Inhibitors in Previously Untreated Patients

An ongoing phase 2 trial (NCT04369937)is testing pembrolizumab plus HPV-16 vaccination and cisplatin in newly diagnosed, locally advanced, intermediate-risk HPV-16–associated HNSCC. Investigators are exploring sequential administration of the ISA101b vaccine before pembrolizumab and chemotherapy treatment, said Ferris. Phase 2/3 trials are evaluating immunotherapies in the maintenance setting, including pembrolizumab in KEYNOTE-412 (NCT03040999) and nivolumab in EA3161 (NCT03811015), along with chemotherapy or radiation in intermediate-risk HPV-16–positive HNSCC.22

Pembrolizumab is also being tested in AHEAD-MERIT (NCT04534205). This phase 2 trial is examining the agent for the first-line treatment of recurrent and/or metastatic HNSCC in combination with an investigational mRNA vaccine, BNT 113, a novel immunotherapy agent that targets the HPV-16 E6/E7 viral proteins.

Another trial is investigating CUE 101, a novel fusion protein designed to activate and expand tumor-specific T cells to treat HPV-driven malignancies. The phase 1 trial (NCT03978689) is accruing and will combine CUE 101 with pembrolizumab in patients with HPV-16–positive recurrent/metastatic HNSCC, including those who previously did not benefit from PD-1/PD-L1 inhibitors.

Immunotherapy with PD-1/PD-L1 inhibitors has advanced the treatment of advanced HNSCC, yet approved treatments do not distinguish between HPV-positive and HPV-negative OPCs. Improved under-standing of HPV-associated tumors shows that immune checkpoint inhibitors have superior clinical benefit in HPV-positive cancers. HPV-targeted vaccines are another promising strategy. Numerous studies combining both immunotherapy approaches in advanced HNSCCs are advancing to late-phase trials and showing higher response rates than those seen with either monotherapy. Results promise to radically change the way clinicians treat HPV-positive cancers through safer, less toxic, and more effective immunomodulatory approaches.

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9. Gardasil 9. FDA. Updated August 21, 2020. Accessed February 28, 2021.https://bit.ly/3bQ7now

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11. Wang C, Dickie J, Sutavani RV, Pointer C, Thomas GJ, Savelyeva N. Targeting head and neck cancer by vaccination. Front Immunol. 2018;9:830. doi:10.3389/fimmu.2018.00830

12. Trimble CL, Morrow MP, Kraynyak KA, et al. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015;386(10008):2078-2088. doi:10.1016/S0140-6736(15)00239-1

13. Le Tourneau C, Cassier P, Rolland F, et al. TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) human papilloma virus (HPV)-16+ cancers: clinical efficacy and immunogenicity. J Immunother Cancer. 2020;8(suppl 3):A841. doi:10.1136/jitc-2020-SITC2020.0793

14. Le Tourneau C, Cassier P, Rolland F, Salas S, Limacher J. TG4001 therapeutic vaccination combined with PD-L1 blocker avelumab remodels the tumor microenvironment (TME) and drives antitumor responses in human papillomavirus (HPV)+ malignancies. Ann Oncol. 2020;31(suppl 7):S1441-S1451. doi:10.1016/annonc/annonc392

15. Kenter GG, Welters MJ, Valentijn AR, et al. Vaccination against HPV-16 oncoproteins for vulvar intraepithelial neoplasia. N Engl J Med. 2009;361(19):1838-1847. doi:10.1056/NEJMoa0810097

16. Bauml J, Seiwert TY, Pfister DG, et al. Pembrolizumab for platinum- and cetuximab-refractory head and neck cancer: results from a single-arm, phase II study. J Clin Oncol. 2017;35(14):1542-1549. doi:10.1200/JCO.2016.70.1524

17. Massarelli E, William W, Johnson F, et al. Combining immune checkpoint blockade and tumor-specific vaccine for patients with incurable human papillomavirus 16-related cancer: a phase 2 clinical trial. JAMA Oncol. 2019;5(1):67-73. doi:10.1001/jamaoncol.2018.4051

18. Burtness B, Harrington KJ, Greil R, et al; KEYNOTE-048 Investigators. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3. Lancet. 2019;394(10212):1915-1928. doi:10.1016/S0140-6736(19)32591-7

19. Diehl MC, Lee JC, Daniels SE, et al. Tolerability of intramuscular and intradermal delivery by CELLECTRA adaptive constant current electroporation device in healthy volunteers. Hum Vaccin Immunother. 2013;9(10):2246-2252. doi:10.4161/hv.24702

20. Chow LQM, Haddad R, Gupta S, et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: results from the phase Ib KEYNOTE-012 expansion cohort. J Clin Oncol. 2016;34(32):3838-3845. doi:10.1200/JCO.2016.68.1478

21. Bagarazzi ML, Yan J, Morrow MP, et al. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Sci Transl Med. 2012;4(155):155ra138. doi:10.1126/scitranslmed.3004414

22. Machiels JP, Tao Y, Burtness B, et al. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncol. 2020;16(18):1235-1243. doi:10.2217/fon-2020-0184

How long will coronavirus vaccines protect people?

How long will coronavirus vaccines protect people?

  • April 4, 2021

“A year ago I tried the Moderna vaccine to see if it was safe. (Spoiler: It is!) Now, on my #COVIDvaccine anniversary, I’m happy to share that I just got a 3rd dose. This booster experiment will reveal (1) if strain-adapted vaccines boost immunity & (2) whether they are safe,” Haydon, a communications specialist at the University of Washington, said via Twitter last Saturday.

“It’s unclear whether this new tweaked version is even going to be necessary,” Haydon told CNN in a telephone interview.

Doctors are worried that coronavirus may end up being like influenza, which requires a new vaccine every year both because the circulating strains mutate fast and because immunity from the vaccine wears off quickly.

Although initial evidence suggests immunity from vaccination against coronavirus provides long-lasting protection, vaccine makers have begun making and testing versions of their vaccines that protect against worrying variants of the virus. That includes the B.1.351 version first seen in South Africa, which carries a mutation that, in lab experiments, appears to allow it to evade the human immune response a little.
The latest report from vaccine maker Pfizer shows people in South Africa who got its coronavirus vaccine after B.1.351 became the dominant circulating virus were still very strongly protected from infection — something that backs up laboratory experiments that have shown the vaccine causes such a strong and broad immune response that it provides a cushion against any effects of mutant viruses.

“It is still matched enough that we have good protection,” said Scott Hensley, an immunologist and vaccine expert at the University of Pennsylvania.

US coronavirus vaccine rollout becomes 'less messy'

But vaccine makers are not taking chances. The trial Haydon is taking part in is testing not only a third dose of Moderna vaccine tweaked to protect specifically against B.1.351 — that’s what he got — but a third dose of original vaccine in some volunteers, too, to see if the boosted immune response is both safe and provides an advantage.

A report out last month from Pfizer suggests people who get both doses keep strong immunity for at least six months. Experts have been at pains to point out that doesn’t mean immunity stops at six months. It means that’s the longest volunteers in the trials have been followed to see what their immunity is. It’s likely to last much longer, Hensley said.

“I would not be surprised if we learned a year from now that these vaccines are still producing a strong immune response,” Hensley told CNN.

“I would not be surprised if this is a vaccine that we only get once.”

Covid-19 reinfections are rare, but more common in people 65 and older, study finds

That would make the vaccine more akin to vaccines against measles than flu vaccines. Vaccination against measles protects against infection for life in 96% of people.

Protection from Pfizer’s two-dose vaccine remains above 91% even at six months, according to the company. It has released the details in a statement, not a formal scientific publication, and the data covers only a few thousand people. But if it holds up, that’s an indication that both the Pfizer and Moderna vaccines elicit a long-lasting immune response, experts say.

Hensley says the technology used by both vaccines — delivery of genetic material known as messenger RNA of mRNA — is especially potent.

“The antibody responses elicited by these mRNA vaccines are incredibly high. What we know in animal models with other mRNA vaccines that have been tested previously — we know that those antibody responses are incredibly long-lived and they don’t drop over time,” said Hensley, whose lab has been testing experimental mRNA vaccines for years.

Single Pfizer vaccine shot provides strong protection for those who've had Covid-19, UK studies suggest

While the coronavirus vaccines are of course new — the virus has only been around since the end of 2019 — the mRNA technology has been studied for many years and used to make vaccines against influenza, Ebola and Zika virus.

Several studies have indicated this with coronavirus vaccine.

In January, a team led by Dr. Alicia Widge at the National Institute of Allergy and Infectious Diseases wrote the New England Journal of Medicine to say their research showed two doses of Moderna’s vaccine produced plenty of antibodies that declined only very slightly over time. The vaccine also caused the body to produce immune cells known as T cells and B cells that can keep defenses going for years. The vaccine-induced immune response was stronger and less variable than the immune response that follows a natural infection, they found.

Another study in the New England Journal of Medicine in February showed blood taken from people who got Pfizer/BioNTech’s Covid-19 vaccine continued to produce an immune response against B.1.351.

Moderna, Pfizer test vaccine strategies against new variants

“Although we do not yet know exactly what level of neutralization is required for protection against Covid-19 disease or infection, our experience with other vaccines tells us that it is likely that the Pfizer vaccine offers relatively good protection against this new variant,” Scott Weaver, director of the Institute for Human Infections and Immunity at University of Texas Medical Branch, told CNN at the time.

Nonetheless, last month, South African virologists argued that there’s growing evidence the vaccines being developed do not work as well against B.1.351 and urged vaccine makes to start tweaking their formulas now.

Although he’s taking part in clinical trials that require regular blood draws to check his immunity, Haydon has no idea how well protected he is from the virus.

“I know that early on in the trial, myself and all the participants did develop neutralizing antibodies — the kind that you are looking for. That was clear many, many months ago,” Haydon said. “But the level of those antibodies, and how the levels have changed over time, is not something that I’m told. That is one of the main things that is being evaluated over the study.”

Lab studies suggest Pfizer, Moderna vaccines can protect against coronavirus variant

He had a strong reaction to the first round of vaccination and said the third dose he just received caused some effects, too.

“Flulike is the right way to describe my symptoms,” he said. “I ended up with a fever, chills, a little bit of nausea, headache,” he added.

Immunologists say that’s a sign the immune system is responding to the vaccine, although people who report no symptoms also develop an immune response, so the symptoms do not appear to suggest someone’s having a better response than someone who doesn’t develop a fever.

Haydon doesn’t know whether his response this time around says anything about what level of immunity he still had from the first dose he was given a year ago.

What he does know is that he cannot behave as if he is completely immune. So he still wears a mask whenever he goes out and has avoided almost all travel.

“We’re living in a world where most people aren’t vaccinated. The fact that you yourself are vaccinated doesn’t change everything for you,” Haydon said.

“We still have to take a lot of the same precautions as an unvaccinated person,” he added. Although your risk of going to the hospital is greatly diminished, spreading the virus is a major concern. It’s not until recently that we started to collect data (showing) that vaccinated people also spread the virus a lot less. So that’s a recent discovery and a very good sign.”

What side effects might I expect from the COVID-19 vaccines? – The Denver Post

What side effects might I expect from the COVID-19 vaccines? – The Denver Post

  • April 1, 2021

If you have not received your COVID-19 vaccination yet, chances are that your number is coming up soon. What can you expect when you get your shot? It’s not a day at the park for many, but others feel nothing. It’s impossible for experts to predict who’s going to feel fine and who’s not. In the vast majority of cases, any side effect you feel will be over within a few days, and there is no reason for concern.

But it is important that the medical and scientific communities talk about the temporary side effects from these vaccines – and that the public know that there is a very small percentage of adverse reactions.

I am an immunologist who studies the fundamentals of immune responses to vaccination, so part of that responsibility falls on me.

Receiving these vaccines will likely make a lot of people feel crappy for a few days. That’s a far better prospect than long-term illness or death. In case you may wonder why it makes anyone feel bad at all, I’ll explain.

Immunology’s “dirty little secret”

In 1989, immunologist Charles Janeway published an article summarizing the state of the field of immunology. Until that point, immunologists had proposed that immune responses were initiated when the immune system encountered anything foreign – bacteria, viruses, and parasites – that it determined to be “non-self.”

Janeway suspected that there was more to the story and famously laid out what he referred to as “the immunologist’s dirty little secret”: Your immune system doesn’t respond just to all foreign things. It responds to foreign things that it perceives to be dangerous.

Now, 30 years later, immunologists know that your immune system uses a complex set of sensors to understand not only whether or not something is foreign, but also what kind of threat, if any, a microbe might pose. It can tell the difference between viruses – like SARS-CoV-2 – and parasites, like tapeworms, and activate specialized arms of your immune system to deal with those specific threats accordingly. It can even monitor the level of tissue damage caused by an invader and ramp up your immune response to match.

Sensing the type of threat posed by a microbe, and the level of intensity of that threat, allows your immune system to select the right set of responses, wield them precisely, and avoid the very real danger of immune overreaction.

Vaccine adjuvants bring the danger we need

Vaccines work by introducing a safe version of a pathogen to a patient’s immune system. Your immune system remembers its past encounters and responds more efficiently if it sees the same pathogen again. However, it generates memory only if the vaccine packs enough danger signals to kick off a solid immune response.

As a result, your immune system’s need to sense danger before responding is at once extremely important and highly problematic. The requirement for danger means that your immune system is programmed not to respond unless a clear threat is identified. It also means that if I’m developing a vaccine, I have to convince your immune system that the vaccine itself is a threat worth taking seriously.

Scientists can accomplish this in a number of ways. One is to inject a weakened – what immunologists call attenuated – or even killed version of a pathogen. This approach has the benefit of presenting a pathogen almost identical to the “real” pathogen, triggering many of the same danger signals and often resulting in strong long-term immunity, as is seen in polio vaccination. It can also be risky – if you haven’t weakened the pathogen enough and roll out the vaccine too fast, there is a possibility of unintentionally infecting a large number of vaccine recipients.

A safer approach is to use individual components of the pathogen, harmless by themselves but capable of training your immune system to recognize the real thing. However, these pieces of the pathogen don’t often contain the danger signals necessary to stimulate a strong memory response. As a result, they need to be supplemented with synthetic danger signals, which immunologists refer to as “adjuvants.”

Adjuvants are safe, but designed to inflame

To make vaccines more effective, entire labs have been dedicated to the testing and development of new adjuvants. All are designed with the same basic purpose – to kick the immune system into action in a way that maximizes the effectiveness and longevity of the response.

If you've had Covid-19, do you still need a vaccine? Here's what the experts say.

Can Covid-19 vaccines be mixed-and-matched? Researchers are working to find out.

  • April 1, 2021

As more Covid-19 vaccines are authorized, scientists are exploring whether different vaccines can be safely and effectively mixed and matched, Carl Zimmer reports for the New York Times—an approach that if proven successful could not only overcome supply setbacks, but may also improve the efficacy of the vaccines.

Toolkit: Covid-19 vaccine communications readiness assessment

Ongoing trials for mixing vaccines

Scientists have long explored the concept of vaccinating people with two different vaccines for the same disease, an approach known as a heterologous prime-boost. The theory is that, because each vaccine trains the immune system to respond in slightly different ways, two different vaccines in combination may produce more robust immunity than two doses of the same vaccine.

However, because of the logistical difficulties and expense in conducting studies of multiple vaccines that may be manufactured by different companies, the real-world efficacy of the approach has rarely been studied in clinical trials.

That changed amid the Ebola outbreak a few years ago, when researchers finally had the opportunity to conduct such resource-intensive work, Zimmer explains.

According to Zimmer, the Gamaleya Research Institute in Russia in 2017 developed a two-dose viral vector Ebola vaccine. For this kind of vaccine, an underlying virus that isn’t risky to humans is modified to produce surface proteins characteristic of a dangerous virus—in this case, Ebola.

The researchers used an adenovirus for the first dose of their regimen and a vesicular stomatitis virus for the second. That approach, Zimmer writes, ensured that recipients wouldn’t develop immunity to the viral vector after the first dose, which could have made the second dose ineffective; instead, both doses would be perceived as new by the immune system.

When Covid-19 hit, the researchers at Gamaleya started developing a two-dose coronavirus vaccine using a similar approach. According to Zimmer, that vaccine, known as Sputnik V, was shown to have a 91.6% efficacy in clinical trials and is being used in 57 countries.

Now, researchers at Gamaleya are partnering with AstraZeneca to determine whether one of the doses used in Sputnik V can pair with AstraZeneca’s Covid-19 vaccine, which uses a chimpanzee adenovirus as its vector. According to a spokesperson for AstraZeneca, a clinical trial for the two shots is underway in Azerbaijan, while another in Russia is currently under review by the ministry of health.

And the research isn’t limited to viral vector vaccines, Zimmer writes. Adam Wheatley, an immunologist at the University of Melbourne, and colleagues are testing a Covid-19 vaccine that uses various parts of the coronavirus’ spike protein—as opposed to genetic instructions for the protein—in its two shots. Specifically, the vaccine involves injecting the full spike protein in the first shot and then, for the second dose, just the tip of the spike protein, known as the receptor-binding domain (RBD).

After injecting the mixture into mice, Wheatley and his team found the mixture worked better than injecting two shots of the spike protein or two shots of the RBD, Zimmer reports. Wheatley and colleagues hypothesize that the first dose produces a wide range of antibodies that stick to various spots along the spike protein, while the second delivers a large supply of strong antibodies to the tip of the spike protein.

“You’re able to basically take that initial immunity that was elicited to that spike vaccine, and then really focus it down onto that RBD,” Wheatley said.

And other trials are blending two different types of vaccines, rather than variations of the same kind. For instance, in an ongoing trial called Com-Cov, researchers at the University of Oxford are testing to see if the Pfizer/BioNTech vaccine, which uses mRNA to create spike proteins, can be effectively paired with AstraZeneca’s adenovirus-based vaccine, Zimmer reports.

In that trial, participants either receive the Pfizer vaccine first followed by the AstraZeneca vaccine or vice versa, and both groups will be compared with volunteers who receive the standard two-dose version of each vaccines. Later this month, researchers will use blood samples from the participants to assess their antibodies and immune system response to determine whether the mixed vaccines create an immune response as strong as the vaccines do on their own.

Why studying vaccine mixing is important

Not only could mixing vaccines reduce supply chain bottlenecks, but some experts believe two different vaccines mixed together could work better than two doses of the same vaccine, Zimmer reports.

Jakob Cramer, head of clinical development at CEPI, a vaccine development organization, said some combinations of vaccines could produce an immune response more effective than a single vaccine. “Immunologically, there are several arguments in favor of exploring heterologous priming,” he said.

However, John Moore, a virologist at Weill Cornell Medicine, cautioned there’s no guarantee that mixing vaccines will work, noting that researchers tried mixing viral vectors and protein boosts in the search for an HIV vaccine and never succeeded. However, the case might be different for Covid-19 vaccines, Moore said.

“I’d like to see these studies done,” he said. “Doing it in the Covid space is completely rational, but may not be necessary.”

Getting vaccine manufacturers to work together on clinical trials could also present a challenge, Zimmer reports, especially as the number of authorized vaccines grow and more companies get involved. “You’re requiring quite large pharmaceutical companies to play nice together,” Wheatley said.

But Bernard Moss, a virologist at the National Institute of Allergy and Infectious Diseases, said he believes many drugmakers will be willing to work together on mixing Covid-19 vaccines. “It’s always better to be a part of something that is going to be used than to wholly own something that isn’t,” he said (Zimmer, New York Times, 3/30).

More Johnson & Johnson COVID Vaccines Expected in Broome

More Johnson & Johnson COVID Vaccines Expected in Broome

  • April 1, 2021

Broome County has just been approved to send medical technicians into homes to vaccinate the home-bound not enrolled in home healthcare programs against COVID-19.

County officials say the Community Peri-Medical Program will start giving one-dose Johnson & Johnson vaccines to the elderly in their homes.

One-dose vaccines were given over the past few weeks to homebound residents who are enrolled in Lourdes at Home and UHS at Home programs.

Several area residents have asked about when they might be able to get the single dose Jenssen Johnson & Johnson shot instead of the two-dose Pfizer or Moderna, which has primarily been offered through the Broome County Point of Distribution at the SUNY Broome Ice Center.  Only one clinic, on March 17, had the J&J vaccine for the eligible general population.

Officials explain, the Johnson and Johnson shot, which doesn’t have to be kept in special, extremely cold freezers, has been directed primarily to programs where it is more difficult to get to a patient or for a patient to return for their second shot.  That could be the home-bound, county jail inmates who frequently aren’t held long enough to get the first dose then the second dose 28 days later or more rural areas where transportation is an issue.

Broome County Public Health Director Rebecca Kauffman says, however there could be some Johnson and Johnson shots available to the eligible general public as early as next week.  Keep checking the county website for vaccination clinic schedules.

KEEP READING: See 25 natural ways to boost your immune system

These at-home exercises can help older people boost their immune system and overall health in the age of COVID-19

What side effects might I expect from the COVID-19 vaccines?

  • April 1, 2021

(The Conversation is an independent and nonprofit source of news, analysis and commentary from academic experts.)

(THE CONVERSATION) Takeaways

You might experience redness and soreness in the arm where you got the shot, tiredness, muscle aches, chills and nausea, but these symptoms won’t last long.

You will be monitored for 15-30 minutes after you get your shot for more serious side effects, which are rare.

Side effects do not mean that you have contracted COVID-19. Vaccines work by training your immune system to recognize and remember a pathogen in a safe way.


Talk to your doctor about over-the-counter pain relievers in case you do experience flu-like symptoms after the shot, but do not take pain relievers before you get the shot.

If you have not received your COVID-19 vaccination yet, chances are that your number is coming up soon. What can you expect when you get your shot? It’s not a day at the park for many, but others feel nothing. It’s impossible for experts to predict who’s going to feel fine and who’s not. In the vast majority of cases, any side effect you feel will be over within a few days, and there is no reason for concern.

But it is important that the medical and scientific communities talk about the temporary side effects from these vaccines – and that the public know that there is a very small percentage of adverse reactions.

I am an immunologist who studies the fundamentals of immune responses to vaccination, so part of that responsibility falls on me.

Receiving these vaccines will likely make a lot of people feel crappy for a few days. That’s a far better prospect than long-term illness or death. In case you may wonder why it makes anyone feel bad at all, I’ll explain.

Immunology’s ‘dirty little secret’

In 1989, immunologist Charles Janewaypublished an article summarizing the state of the field of immunology. Until that point, immunologists had proposed that immune responses were initiated when the immune system encountered anything foreign – bacteria, viruses, and parasites – that it determined to be “non-self.”

Janeway suspected that there was more to the story and famously laid out what he referred to as “the immunologist’s dirty little secret”: Your immune system doesn’t respond just to all foreign things. It responds to foreign things that it perceives to be dangerous.

Now, 30 years later, immunologists know that your immune system uses a complex set of sensors to understand not only whether or not something is foreign, but also what kind of threat, if any, a microbe might pose. It can tell the difference between viruses – like SARS-CoV-2 – and parasites, like tapeworms, and activate specialized arms of your immune system to deal with those specific threats accordingly. It can even monitor the level of tissue damage caused by an invader and ramp up your immune response to match.

Sensing the type of threat posed by a microbe, and the level of intensity of that threat, allows your immune system to select the right set of responses, wield them precisely, and avoid the very real danger of immune overreaction.

Vaccine adjuvants bring the danger we need

Vaccines work by introducing a safe version of a pathogen to a patient’s immune system. Your immune system remembers its past encounters and responds more efficiently if it sees the same pathogen again. However, it generates memory only if the vaccine packs enough danger signals to kick off a solid immune response.

As a result, your immune system’s need to sense danger before responding is at once extremely important and highly problematic. The requirement for danger means that your immune system is programmed not to respond unless a clear threat is identified. It also means that if I’m developing a vaccine, I have to convince your immune system that the vaccine itself is a threat worth taking seriously.

Scientists can accomplish this in a number of ways. One is to inject a weakened – what immunologists call attenuated – or even killed version of a pathogen. This approach has the benefit of presenting a pathogen almost identical to the “real” pathogen, triggering many of the same danger signals and often resulting in strong long-term immunity, as is seen in polio vaccination. It can also be risky – if you haven’t weakened the pathogen enough and roll out the vaccine too fast, there is a possibility of unintentionally infecting a large number of vaccine recipients.

A safer approach is to use individual components of the pathogen, harmless by themselves but capable of training your immune system to recognize the real thing. However, these pieces of the pathogen don’t often contain the danger signals necessary to stimulate a strong memory response. As a result, they need to be supplemented with synthetic danger signals, which immunologists refer to as “adjuvants.”

Adjuvants are safe, but designed to inflame

To make vaccines more effective, entire labs have been dedicated to the testing and development of new adjuvants. All are designed with the same basic purpose – to kick the immune system into action in a way that maximizes the effectiveness and longevity of the response.

To do this, we take advantage of the same sensors that your immune system uses to sense damage in an active infection. That means that while they will stimulate an effective immune response, they will do so by producing temporary inflammatory effects.

At a cellular level, the vaccine triggers inflammation at the injection site. Blood vessels in the area become a little more “leaky” to help recruit immune cells into the muscle tissue, causing the area to become red and swell. All of this kicks off a full-blown immune response in a lymph node somewhere nearby that will play out over the course of weeks.

In terms of symptoms, this can result in redness and swelling at the injection site, stiffness and soreness in the muscle, tenderness and swelling of the local lymph nodes and, if the vaccine is potent enough, even fever (and that associated generally crappy feeling).

This is the balance of vaccine design – maximizing protection and benefits while minimizing the uncomfortable, but necessary, side effects. That’s not to say that serious side effects don’t occur – they do – but they are exceedingly rare. Two of the most discussed serious side effects, anaphalaxis (a severe allergic reaction) and Guillain-Barré Syndrome (nerve damage due to inflammation), occur at a frequency of less than 1 in 500,000 doses.

Vaccination against SARS-CoV-2

Early data suggest that the Moderna and Pfizer mRNA vaccines against SARS-CoV-2 are highly effective – upwards of 90%. The Johnson & Johnson vaccine is also highly effective, although it was not developed using mRNA technology. All three are capable of stimulating robust immune responses, complete with sufficient danger signaling, to prevent severe COVID-19 in greater than 9 out of 10 patients. That’s a high number under any circumstances, and suggests that these vaccines are potent.

In an early release of the phase 3 trial data, more than 2% of the Moderna vaccine recipients experienced what they categorized as severe temporary side effects, such as fatigue and headache. However, more mild side effects are common – particularly after the second dose. These are signs that the vaccine is doing what it was designed to do – train your immune system to respond against something it might otherwise ignore so that you’ll be protected later. It does not mean that the vaccine gave you COVID-19.

[Research into coronavirus and other news from science Subscribe to The Conversation’s new science newsletter.]

It all comes down to this: By getting vaccinated, you protect yourself, your loved ones and your community from a highly transmissible and deadly disease. It may cost you a few days of feeling sick.

Editor’s Note: This article is updated from a previous version, which was published originally Dec. 3, 2020.

This article is republished from The Conversation under a Creative Commons license. Read the original article here: https://theconversation.com/what-side-effects-might-i-expect-from-the-covid-19-vaccines-158278.

All you need to know about the vaccines – Monash Lens

All you need to know about the vaccines – Monash Lens

  • April 1, 2021

How many vaccines are there?

There are two currently in Australia, but others are available internationally, and potentially eventually here.

The COVID-19 vaccines currently approved by the Australian medicine regulator (the Therapeutic Goods Administration) are the Pfizer/BioNTech vaccine (Tozinameran) and the AstraZeneca vaccine (AZD1222). They’re both derived from new technologies that are well-suited for responding to emerging epidemics.

How do they work?

The Pfizer/BioNTech vaccine is a messenger RNA (mRNA) vaccine. Every cell in our bodies produces their mRNA naturally. Its purpose is to deliver instructions for our cells to create a diverse range of proteins necessary for everyday function and survival.

The Pfizer/BioNTech mRNA vaccine is produced synthetically and is delivered into our cells using a tiny fatty coat (a lipid nanoparticle) to protect and deliver the RNA.

The AstraZeneca vaccine uses DNA as an instruction instead of mRNA. The DNA is coated in a harmless common-cold virus from the chimpanzee (Chimpanzee Adenovirus Oxford, or ChAdOx) to deliver the DNA into our cells.

Both vaccines carry the instructions to make an antigen called the spike protein. Antigens make antibodies in the immune system. In a virus, this protein helps it enter our cells. In vaccines, it’s produced without any other viral parts.

Once the instructions reach our cells and the antigen is made, then our immune system is trained to recognise the antigen, so when we’re exposed to the actual virus, our trained immune system stops the virus from infecting us.

A mRNA starnd, with a COVID-19 vaccine vial in the foreground

Is one better than the other?

The most up-to-date data has shown Pfizer/BioNTech to be 90 to 95% effective, and AstraZeneca up to 79% effective in preventing symptomatic COVID-19. However, it’s important to remember that the efficacy studies were not identical in design, so making direct comparisons is difficult.

Both vaccines protect exceptionally well against severe infection and hospitalisation in the most prevalent variants of the virus found here in Australia (for example, the “G-variant” also known as D614G). It’s really important to note that the vaccines may not have the same effectiveness against new viral variants (such as the South Africa variant).

More research is needed to understand how vaccines prevent hospitalisation against new variants. For these reasons, our public health system must maintain close monitoring on those variants from all overseas arrivals until further research or an alternative vaccine is made.

Are they safe?

Yes. Both vaccines have excellent safety profiles, and most side effects are mild. Importantly, their benefit far outweighs any of the mild symptoms they cause. In very rare circumstances, the vaccines can cause an allergic reaction.

We have systems in place if any allergic reactions occur after administration.


Read more: From Baghdad to Melbourne: Dr Harry Al-Wassiti’s remarkable journey


There has also been some discussions overseas about the potential for the AstraZeneca vaccine, in very rare cases, to cause blood clots. The data to support this suggestion is not strong, with reviews concluding that the benefits of the vaccine continue to outweigh the risks, and the vaccine is not associated with an increase in the overall risk of blood clots. For the most up to date information, visit the Therapeutic Goods Association website.

Why do I need to get jabbed twice?

For any new viruses, our immune system lacks the training needed to fight the virus. The first injection trains our immune system to develop the necessary immunity. The second shot boosts that immunity to generate protective antibodies at a level higher than the infection.

In addition, having those protective antibodies at a high level appears to protect us for a longer period of time.

How do I get vaccinated?

The current vaccination program is staged according to priority. People with the highest risk can receive the vaccine first. The stages of the vaccine rollout are here. Trained doctors, nurses or pharmacists perform vaccinations, so please contact your local GP or pharmacist when your stage is ready for rollout. The Age have mapped participating GPs here.

Do I have to be vaccinated?

No, currently vaccination is not mandatory, though most people are expected to be vaccinated. There are some health-related exceptions for people with pre-existing conditions.

For example, those people may suffer from immune diseases that compromise their immune system. Please contact your local GP or pharmacist if you’re unsure.

A high percentage of community vaccination is needed to protect the population from outbreaks and viral spread. This is called herd immunity. And it’s our shared responsibility to take the safe vaccines to protect our communities and loved ones.

Why is this “herd immunity” so important?

Herd immunity – with lots of people vaccinated – will be vital to live with COVID-19. Herd immunity is the level of community immunity against a virus, by vaccination. It resembles a shield with the goal to stop community outbreaks.


Read more: COVID-19 vaccines, funding, spike proteins, and the work being done to block the deadly virus


Higher herd immunity means the community is better-protected from the spread of COVID-19. That means that even if a member of the community is infected with COVID-19, there would be no major outbreaks, as the community will shield itself against the spread.

Will there be another coronavirus pandemic, and will the vaccines still work?

Coronaviruses are common viruses that cause a range of diseases, from mild common cold to severe respiratory syndromes.

Novel or new coronaviruses have emerged in humans at least three times in the past 20 years. With constant pressures such as climate change and increased animal habitat destruction, coronaviruses and other viruses will likely emerge in the future.

The short-term challenge is to ensure that our current vaccines will work against emerging variants of COVID-19, or to produce a strain-specific vaccine.

A 2021 COVID vaccination sign

Is the Australian rollout working efficiently?

It’s faced some setbacks and challenges, as the rollout of Pfizer/BioNTech vaccine has not caught up to the original timeline. But with the local production of the AstraZeneca vaccine by CSL and Seqirus currently at maximum capacity, it’s expected the rollout will be close to meeting the proposed finish date of October.

Many challenges remain ahead to meet the target, but locally-produced vaccines will certainly help.

Are the vaccines imported, or are we making them here?

Australian CSL-Seqirus manufacturing will produce the vast majority of our AstraZeneca shots. The majority of Australians will receive this vaccine. But the Pfizer/BioNTech (mRNA) vaccine is manufactured overseas and imported into Australia. Currently, Australia cannot manufacture mRNA onshore.

Will there be better vaccines in the future?

Yes. There’ll be new generations of vaccines that will improve on the current vaccines. We at Monash have an mRNA vaccine program at our Parkville campus, and others around the world are continuously developing new vaccine technologies.

In the context of COVID-19, new vaccines will be targeted towards new variants and mutants that are emerging.

Improvement in the technology, particularly mRNA vaccines, will likely produce vaccines with high effectiveness but lower doses and fewer injection side effects.

Vaccines to target mutant strains are already in development or trials, particularly against the South African and Brazilian variants.

 

capsimmunesystem.org