Category: Covid-19 Vaccine

We asked you to tell us your biggest questions about the COVID-19 vaccines. Here are some answers. USA TODAY

A committee crucial for clearing a COVID-19 vaccine will hold an all-day meeting Thursday, and depending on how it votes, the nation's first doses could ship as early as Friday.

The external expert committee will review data from Pfizer and German startup BioNTech on their vaccine, called BNT162b2, and by day's end will vote whether the U.S. Food and Drug Administration should authorize the countrys first COVID-19 vaccine.

The companies are requesting an emergency use authorization, shy of a full approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed. But corners, FDA says, have not been cut.

If the independent Vaccines and Related Biological Products Advisory Committee recommends that authorization, the FDA is expected to sign off on the vaccine, possibly as soon as late Thursday.

'Very inconsistent': 2 allergic reactions in the UK to COVID-19 vaccine puzzle researchers

Another committee, convened by the U.S. Centers for Disease Control and Prevention, will meet Friday and Sunday to officially determine who should receive the first doses. Depending on timing, the first Americans could start to be vaccinated by the weekend, though more likely Monday.

The VRBPAC meeting (pronounced verb-pack), is one of the final pieces in a process that began in January when workbegan on a vaccine to help end the global coronavirus pandemic. Just 10 months later, on Nov. 20, Pfizer and BioNTechbecame the first tosubmittheir application to FDA for general use in the U.S.

Another COVID-19 vaccine, developed by Cambridge, Massachusetts-based Moderna, will go through the same approval processnext week. Its candidate goes before the FDA committee Dec. 17.

No fully vetted vaccinehas ever been developed more quickly. The previous record was four years for one against the mumps.Vaccine developers saved time by conducting steps at the same time that are usually done in sequence.

Despite the swift pace, experts stress the process has been painstaking and methodical, and FDA's scientific experts will comb the data submitted by the companies.Everything is double-checkedand nothing is taken for granted.

They even go through it line by line and check all the math, do all the statistical analyses over again, saidDr. Gregory Poland, director of the Mayo Vaccine Research Group and editor-in-chief of the journal Vaccine.

"They're really making sure that no stone left goes left unturned in terms of evaluating the safety and the efficacy of these vaccines," said Dr. William Moss, an epidemiologist with the International Vaccine Access Center.

A vial of the COVID-19 candidate vaccine developed by BioNTech and Pfizer is displayed at the headquarters in Puurs, Belgium.(Photo: AP Images)

The unprecedented speed at which the COVID-19 vaccines have beenbrought to market belies the truth about vaccine development: Most efforts fail.

Only about 1 in 6 make it all the way through approval. Decades of tedious work can be upended by spectacular failuresand the most promising paths can turn into dead ends.

Nature gives up its secrets slowly and grudgingly. Its a constant struggle to prove that a product you think saves lives actually does, said Dr. Paul Offit,director of the Vaccine Education Center at Children's Hospital of Philadelphiaand a professor of vaccinology at the Perelman School of Medicine at the University of Pennsylvania.

Vaccines take years and sometimes decades to develop for a reason. There are so many hoops to jump thatits hard to even count the hundreds of points where something could go wrong and knock a candidate out of the running.

Getting a vaccine has been a huge undertaking. How all 50 states scramble to dole them out is the next massive challenge.

Everyone who works in the field knows they should never get their hopes up.

The nature of vaccine development is there are always surprises, said Poland. After four decades working the field, his advice is expect the unexpected.

Vaccines are first tested in cellsthen in animals.If things go well in animals, the company or researchers working on the vaccine apply to the FDA to test it in a very small number of humans to make sure it doesnt hurt people.

Those first humantests are wheremost vaccine creators hopes and dreams end. What works in animals, theyve learned the hard way, usually doesnt work in people.

The Phase 1 trial is where 90% of vaccines die, said Dr. Corey Casper, CEO of the Infectious Disease Research Institute in Seattle and a professor of global health at the University of Washington.

If a vaccine clears Phase 1, it still can be rejected in larger Phase 2 and the much larger Phase 3 human trials, which are guided by external expert committees with the power of life and death over the process.

Almost 15% of candidate vaccines get bad news when trials expand,according to research by the Massachusetts Institute of Technology.

Its one of the most dejecting feelings. Its like getting a holiday present and theres nothing in the box, said Casper. You feel horrible. Youve done all this work, youve spent all this and youve gotten people to volunteer their time and their bodies and they didnt benefit."

The frontrunning COVID-19vaccines got lucky.

Data fromPfizer/BioNTech's Phase 3 trial showed itprevented 95% of people from becoming sick. Moderna's vaccine, based on the same messenger RNA technology, showed similar effectiveness. The findings bode well for their FDA blessing.

Phil Dormitzer, chief science officer for Pfizers viral vaccine research and development division, received the good news Nov. 9.

He wasat home in Nyack, New York, when he opened his email at 6:15 a.m.and saw the subject line.

Ill be honest with you, it was somewhat overwhelming. I was stopped in my tracks, it was a real rush of emotion, he said.

Later in the day his team held a brief celebratory teleconference but then they went back to work.

To actually get this vaccine authorized, manufactured and distributed," he said, "theres still a huge amount that has to be done."

Contact Elizabeth Weise at eweise@usatoday.com

Answers to your vaccine questions: Are there side effects to a COVID-19 vaccine? What are the 'ingredients'? The cost?

More: Moderna becomes second company to request emergency FDA authorization for COVID-19 vaccine candidate

Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time. USA TODAY

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Pfizer's COVID-19 vaccine finally reaches its last step: FDA committee vote. Most vaccines never get that far. - USA TODAY

TAHLEQUAH, Okla. (KFOR) A tribal nation says it is set to receive its first doses of the COVID-19 vaccine next week.

The Cherokee Nation says it will receive 975 of the first doses of the Pfizer COVID-19 vaccine next week.

We have been working with IHS and following CDC guidelines to create a prioritization plan that will include our frontline health care workers and those who are at high risk of infection to be among the first to receive the vaccine so that we can get our most vulnerable and at-risk populations vaccinated, said Brian Hail, Deputy Executive Director of External Operations for Cherokee Nation Health Services.

Tribal leaders say they will vaccinate frontline healthcare workers, emergency responders, Cherokee speakers, Cherokee National Treasures, and elders over the age of 65.

Taking a COVID-19 vaccine is another step forward to saving lives among our Cherokee people and helping stop the spread of this deadly virus in our Cherokee communities, Cherokee Nation Principal Chief Chuck Hoskin Jr. said. I know some of our Cherokee elders may have reservations about taking the vaccine, but it will save our elders, our speakers, our National Treasures and frontline workers. As we continue our phased plan and get more doses into 2021 to begin vaccinating our employees and citizens, we can begin the process of healing from what we know is the worst public health crisis our tribe has faced in generations.

Officials say they have made several updates to their facilities in order to keep the COVID-19 vaccines stored properly.

The vaccine will be given in two doses with the second dose given exactly 21 days after the first.

The more of our frontline staff that receive the vaccine puts us in line to receive larger allocations in the future. Use of this first allocation and the time in which we administer it, is very important to benefit our communities moving forward, said Dr. R. Stephen Jones, Executive Director of Cherokee Nation Health Services.

Once the first group of Cherokee citizens is vaccinated, officials say they plan to provide vaccines to non- healthcare critical staff like teachers, childcare providers, food security staff, shelter staff, and those with underlying health conditions.

So far, the Cherokee Nation has had nearly 7,000 positive cases of COVID-19 and 50 deaths, including 20 Cherokee speakers within its health system.

As the COVID-19 vaccine becomes more readily available, the tribe encourages everyone to continue to wear a mask, wash their hands regularly and observe social distancing. The benefit provided by the vaccine will take several months before it decreases the amount of community spread and impact to Cherokee families and communities.

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Cherokee Nation to receive first doses of COVID-19 vaccine next week - KFOR Oklahoma City

Public health officials have confirmed that people will be given a COVID-19 Vaccination Record Card after they receive their first dose of the coronavirus vaccine, CNN reports. The documentation will help officials keep track of who has received the shot, and help people follow through with the second dose of their vaccination schedule, Kelly Moore, associate director of the Immunization Action Coalition, told the news outlet.

Everyone will be issued a written card that they can put in their wallet that will tell them what they had and when their next dose is due, Moore explained. Lets do the simple, easy thing first. Everyones going to get that.

Clinics that offer the vaccine will also log patient information in their state immunization registries to track which shot was given, as two vaccine candidates from pharmaceutical giants Pfizer and Moderna are currently pending emergency use authorization from the FDA. This will make it easier for doctors and healthcare providers to find that information if a patient was unsure of their vaccination details, Moore says.

The card will be part of an overall vaccination kit, which will also include a needle and syringe, alcohol wipes, and a face mask.

U.S. Department of Defense

The cards were also mentioned in a press briefing with members of the federal governments Operation Warp Speed. Weve set up everything [in] a draconian process, where when we sent out the ancillary kits which have needles and syringes, weve included paper cards to be filled out and ... given to the individuals, reminding them of their next vaccine due date, Army Gen. Gustave Perna, Warp Speeds chief operating officer, said in the briefing. He added that people will be asked to take a photo of their vaccination cards or to keep them in their wallet.

This isnt a concept unique to COVID-19. Vaccination cards are already distributed when people are vaccinated against certain infectious diseases, including smallpox and yellow fever.

The World Health Organization (WHO) has an international certificate of vaccination or prophylaxis that can be carried by a person who has been vaccinated. I carry a yellow fever card around in my wallet, says infectious disease expert Amesh A. Adalja, M.D., senior scholar at the Johns Hopkins Center for Health Security.

There was a time when pediatricians were giving out vaccination cards to parents after routine childhood vaccines, but so many parents lost them and didnt keep up with them that people gave that up about 25 years ago, says William Schaffner, M.D., an infectious disease specialist and professor at the Vanderbilt University School of Medicine. Now, for certain diseases, you have to have a vaccination certificate or card if youre going to certain countries.

A COVID-19 vaccination card will feature a persons first and last name, birthdate, the vaccines name and maker, and the dates of when the first and second dose were received, according to a sample image from the U.S. Department of Defense. (Both vaccines pending approval will require two doses.)

U.S. Department of Defense

Back in April, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases, said that there were talks of using vaccination cards or certificates for the COVID-19 vaccine. You know, thats possible, he said on CNNs New Day at the time. Its one of those things that we talk about when we want to make sure that we know who the vulnerable people are and not.

Its unclear at this point how COVID-19 vaccine cards will be used, but experts have confirmed that their main purpose is to simply make sure people follow through with the second dose of the vaccine. It will be very important ... for all Americans who get the Moderna or the Pfizer vaccine to have their first vaccine dose and then come back either three or four weeks later to get their second vaccine dose, to complete the immunization schedule, said Moncef Slaoui, M.D., Warp Speeds chief scientific adviser, per NPR.

Moore told CNN that vaccine distribution sites will likely ask you for your cell phone number, so you can also receive a text message to remind you to get your next dose.

Richard Watkins, M.D., an infectious disease physician and professor of internal medicine at the Northeast Ohio Medical University, says the cards might be especially useful for workers that interact with the public and vulnerable populations frequently, like healthcare providers, restaurant servers, and teachers.

Officials have not confirmed that the cards will be used for travel or large events.

Overall, experts say vaccination cards will bring us one step closer to ending the pandemic. Both Pfizer and Moderna have vaccine candidates that are reported to be more than 90% effective at preventing COVID-19 infection in people whole participated in phase 3 clinical trials. The White House Coronavirus Task Force expects the first doses to be administered to healthcare workers and elderly residents of long-term care facilities as soon as mid-December.

It is unlikely that the general public will have access to the vaccine until late spring to summer of 2021, Dr. Adalja says. But when it becomes available to you, its crucial that you get it. Nearly 300,000 Americans have died of COVID-19 so farand getting vaccinated will help save lives. I would be proud to show my coronavirus vaccine card to people, Dr. Adalja says.

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Heres Why Youll Be Given a Vaccination Card After You Get the COVID-19 Vaccine - Prevention.com

COVID-19 vaccines should dramatically drive down the rate of new cases, hospitalizations and deaths in the U.S. provided that enough people get the shots.

According to a new model, posted Nov. 30 to the preprint database medRxiv, vaccinating just 40% of the U.S. population would cut the attack rate, or new infections from the virus, more than four-fold over the course of one year. That reduction would occur both by directly protecting those who get the shots and indirectly protecting others in the wider community.

Without any vaccines, about 7% of susceptible people would get infected over the next year, the authors estimated. That's assuming people comply with measures like social distancing and mask-wearing; the attack rate would likely be higher without such precautions in place.

The low attack rate with vaccines translates to fewer hospitalizations and deaths from COVID-19; with 40% of the population vaccinated, both ICU and non-ICU hospitalizations would fall more than 85%, according to the model. Deaths would fall by more than 87% compared with a year-long scenario with no vaccinations.

Related: 20 of the worst epidemics and pandemics in history

Does that mean we can throw caution to the wind and stop social distancing if 41% of the population gets vaccinated? No, not exactly.

About three-quarters of the population will likely need to be vaccinated before we can safely begin easing restrictions, given how easily COVID-19 spreads between people, said study author Meagan Fitzpatrick, an assistant professor and infectious disease transmission modeler at the University of Maryland School of Medicine. In addition, the new model has not yet been peer-reviewed, and in any case, it cannot perfectly predict what will happen once Americans are vaccinated.

But the study does give us reason for hope, Fitzpatrick said. With such highly effective vaccines under review, "the strategy now is to try to get these vaccines into as many people as possible," she said.

The two leading vaccine candidates one designed by Moderna and the other by Pfizer and BioNTech are both more than 94% effective at preventing COVID-19, according to early analyses. That level of efficacy is "so much higher than any of us had a right to expect one year into the pandemic," Fitzpatrick said. "What our research confirms is that these vaccines with extraordinarily high efficacy really do have the potential to make a huge impact," she said.

In their model, the study authors assumed that people with the highest risk of COVID-19 exposure and death would receive the vaccine first. These included a large proportion of all health care workers, people with existing medical conditions and individuals ages 65 and older. Individuals younger than age 65 received the vaccine next, and no individuals under 18 got the shots, since none of the leading vaccines have been tested thoroughly in children yet.

In addition, the authors assumed that 10% of the population had already caught COVID-19 and developed natural immunity to the virus. "Ten percent is fair, but may be an underestimate in some places" where case counts have been particularly high, Stanley Perlman, a professor of microbiology and immunology at the University of Iowa, who was not involved in the study, said in an email.

Related: Here are the most promising coronavirus vaccine candidates out there

Given these parameters, the model showed that vaccinating 40% of the population substantially reduced case counts, hospitalizations and deaths from COVID-19.

The most dramatic drop occurred in people ages 65 and older, who experienced an 83% to 90% reduction in potential cases. People ages 20 and younger had half as many new infections, even though no one under 18 was vaccinated. In other words, while older adults got direct protection from the vaccine, young adults and children were indirectly protected as immunity increased in the community at large, Fitzpatrick said.

After seeing the impact of 40% vaccination rates, the authors tested what would happen with only 20% of the population vaccinated. Again, the model prioritized vaccinating those at high risk of exposure and severe illness. Even with such low vaccine coverage, non-ICU hospitalizations fell by 60%, ICU hospitalizations by 62% and deaths by more than 64%. This suggests that, as vaccines begin to roll out, we may begin to see their positive impacts even before many people get the shots, Fitzpatrick said.

While the study highlights the power and promise of COVID-19 vaccines, the study authors cautioned that vaccines must be paired with other safeguards against the virus, such as masking, testing and contact tracing. If we drop those safeguards too soon, more people would need to be vaccinated to prevent a spike in new cases, they wrote.

"I think that we [will] need social distancing and masks for many months still," Perlman said. "Opening up restaurants and allowing mass gatherings will need to be done very cautiously until vaccination rates are high," he noted.

If anything, contact-tracing efforts should ramp up as vaccines roll out, so health officials can quickly spot new outbreaks and identify communities that should be prioritized for vaccination, Fitzpatrick said.

Reaching high-risk groups will be critical to stopping the pandemic, and this is one way in which the model might differ from reality. In the model, vaccination rates were assumed to be similar across the whole country, and those in high-risk groups always got their shots first. What's more, both of the leading vaccines require two shots given several weeks apart, and in the model, everyone in the model got both doses of the vaccine.

In reality, "vaccination programs often miss their targets," said Dr. Eric Schneider, senior vice president for policy and research at The Commonwealth Fund, a national organization that researches health and social policy issues, who was not involved in the study. "If, in reality, lower-risk individuals ... are more likely than higher-risk individuals to receive [a] vaccine, then the model overstates the effect of the vaccination program," Schneider said in an email.

In other words, the model will reflect reality only if the U.S. follows through with its plan to give high-risk groups the vaccine first. To work, this plan must be well-coordinated at all levels of the government and health care system, and paired with clear communication about the vaccine's risks and benefits, according to a recent report by The Commonwealth Fund.

And of course, once a vaccine becomes available, those offered access must agree to take it, Fitzpatrick said. "A vaccine only works if people take it."

Recent surveys hint that many U.S. residents would probably or definitely get a COVID-19 vaccine if offered one today, but a smaller proportion say that they probably or definitely would not. These reports should be taken with a huge grain of salt, though, because "what someone says they're going to do in a survey doesn't always represent what they're actually going to do," Fitzpatrick said.

Thankfully, while we wait to see what happens, "I think there's a lot of reason to be hopeful," she added.

Originally published on Live Science.

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When will COVID-19 vaccines start to make a difference? - Livescience.com

Long-term care facilities are set to be included in the first group of COVID-19 vaccinations in New Hampshire. On Wednesday, new information was revealed on the timeline and number of vaccine doses coming to the state.>> Download the FREE WMUR appThe first shipment of vaccine could be in New Hampshire by the middle of next week, in limited amounts. There will be 12,675 doses of the Pfizer vaccine allocated to start, with a larger allocation of the Moderna vaccine the week of Dec. 21, according to Dr. Beth Daly of Health and Human Services. Then we will continue to receive weekly allocations thereafter, Daly said. We do not know the exact amount of what that will be.Reaffirming to long-term care facilities on the weekly call, that they will be prioritized, along with at-risk health workers and first responders, also as early as the week of Dec. 21. We are meeting regularly with the pharmacies to understand their plan for New Hampshire, what does that mean for Dec. 21, what is that going to look like, how many facilities are they planning to do each week, Daly said. The safety of the vaccine was discussed and the most common side effects from pain, redness and swelling at the injection site. To fatigue, headache, muscle and joint pain, chills and fever. A complicating factor because people are screened for fever before they enter facilities.So, if somebody was vaccinated 24 hours before it seems to be that 14% of those may have some fever so essentially be screened out, Dr. Elizabeth Talbot said. The state is working on a strategy for that, along with other information to be released in the days ahead.And officials issued a reminder, with little known about the transmissibility of the virus, once someone has gotten the vaccine, we need to keep our guard up.Tempering our collective enthusiasm, theres really good news here, but we still need to maintain all the different strategies weve put in place to prevent transmission, Talbot said.

Long-term care facilities are set to be included in the first group of COVID-19 vaccinations in New Hampshire. On Wednesday, new information was revealed on the timeline and number of vaccine doses coming to the state.

>> Download the FREE WMUR app

The first shipment of vaccine could be in New Hampshire by the middle of next week, in limited amounts. There will be 12,675 doses of the Pfizer vaccine allocated to start, with a larger allocation of the Moderna vaccine the week of Dec. 21, according to Dr. Beth Daly of Health and Human Services.

Then we will continue to receive weekly allocations thereafter, Daly said. We do not know the exact amount of what that will be.

Reaffirming to long-term care facilities on the weekly call, that they will be prioritized, along with at-risk health workers and first responders, also as early as the week of Dec. 21.

We are meeting regularly with the pharmacies to understand their plan for New Hampshire, what does that mean for Dec. 21, what is that going to look like, how many facilities are they planning to do each week, Daly said.

The safety of the vaccine was discussed and the most common side effects from pain, redness and swelling at the injection site. To fatigue, headache, muscle and joint pain, chills and fever. A complicating factor because people are screened for fever before they enter facilities.

So, if somebody was vaccinated 24 hours before it seems to be that 14% of those may have some fever so essentially be screened out, Dr. Elizabeth Talbot said.

The state is working on a strategy for that, along with other information to be released in the days ahead.

And officials issued a reminder, with little known about the transmissibility of the virus, once someone has gotten the vaccine, we need to keep our guard up.

Tempering our collective enthusiasm, theres really good news here, but we still need to maintain all the different strategies weve put in place to prevent transmission, Talbot said.

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Limited amounts of COVID-19 vaccine expected to start arriving in NH next week - WMUR Manchester

COVID 19 vaccine: Principal investigator in Moderna study on why she thinks you should trust the vaccine  WTVD-TV

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COVID 19 vaccine: Principal investigator in Moderna study on why she thinks you should trust the vaccine - WTVD-TV

As one of two COVID-19 vaccines go up for FDA approval, can employers mandate you get thevaccine when its available?

The County Executive and director of the Health Department both encourage employers to push for their employees to get the covid-19 vaccine when it becomes available.

The more people that are vaccinated, the quicker we are going to get out of this pandemic and the faster we will get to a recovery stage,says Melissa Lyon, director of the Erie County Department of Health.

County Executive Kathy Dahlkemper adds that the vaccine could be a proactive measure to the economic downfall of the pandemic.

A healthy population, good public health is absolutely essential to good economic development and to a thriving economy,says Dahlkemper.

There is no official word on if a coronavirus vaccine would be mandatory for workers.

In general, yes an employer would have the right to require vaccine of their employees; particularly an at-will employer,says lawyer Timothy McNair.

Exceptions to a potential vaccine mandate would include medical issues or religious beliefs.

They would have to be accommodated either by working separately, working off site, whatever the employer can do that is reasonable,says McNair.

However, it does not guarantee the employee would keep their job.Also, if company employees are represented by a union, a vaccine mandate could become an issue for collective bargaining.

As the general public waits for the vaccine to roll out for distribution, we decided to talk to members to see if they are readyto get the dose themselves.

Yes, I work in healthcare. Im excited for it, I hope it helps everyone, says healthcare worker Tracy Wentz.

Yeah, Ill get it. I think it works according tonews,says Erie Resident James Kerney Jr.

Idontknow if I would because I think theres people that would need it more and I respect that,says Erie Resident Stefanie Seath.

Secretary of Health Dr. Rachel Levine says there is not a mandate in place for public school students to get the COVID-19 vaccine.

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Can the COVID-19 vaccine be mandated? - YourErie

Modernas COVID-19 vaccine, one of two expected to come on line before the end of the year.

As federal experts determined that known and potential benefits outweigh the related risks when it comes to Pfizers COVID-19 vaccine, New Jersey officials are poised in the coming weeks to launch their part of what is likely the largest immunization campaign in history.

Gov. Phil Murphy said Tuesday that state officials have fine-tuned their vaccine plan and are working with a network of public and private health-care providers and other stakeholders to be ready. They aim to begin immunizing priority individuals within a day or so of a final federal approval, which could come as early as Thursday.

Its safe based on everything we know, Murphy said Tuesday during a public conversation with SkyBridge Capitals founder and partner Anthony Scaramucci, who briefly served as President Donald Trumps communication director. (Both Murphy and Scaramucci worked at Goldman Sachs.)

The state hopes to get 70% of the eligible population, some 4.7 million adults, immunized within six months of the vaccine becoming available to the general public, likely April or May 2021. Thats a reach, but were going to try, Murphy said.

As of Tuesday afternoon, heres where the process stands:

Mass vaccinations have already begun in the United Kingdom, where Monday marked the start of what is being called V-day, just a year after the novel coronavirus first emerged in Wuhan, China. In Britain, vaccines will be administered at roughly 50 public hospitals and the priority is residents over age 80 who are hospitalized or have outpatient appointments at the facility, according to news reports.

First up was grandmother Margaret Keenan, due to turn 91 next week, the AP reported. Its the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year, Keenan said.

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The COVID-19 vaccine: What we know - NJ Spotlight

FDA could give the green light for Pfizers Covid-19 vaccine Thursday  ActionNewsJax.com

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FDA could give the green light for Pfizers Covid-19 vaccine Thursday - ActionNewsJax.com

The UK began vaccinating elderly people and medical workers with a vaccine developed by American drugmaker Pfizer and Germany's BioNTech, the world's first rollout.

LONDON, UK Britain's medical regulator warned Wednesday that people with a history of serious allergic reactions shouldnt receive the COVID-19 vaccine from Pfizer and BioNTech as investigators look into whether two reactions on the first day of the countrys vaccination program were linked to the shot.

Professor Stephen Powis, medical director for National Health Service in England, said the advice was issued on a precautionary basis and that the people who had reactions had recovered.

Pfizer and BioNTech said they were working with investigators to better understand each case and its causes.

In the meantime, the Medical and Healthcare Products Regulatory Agency has said people should not received the vaccine if they have had a significant allergic reaction to a vaccine, medicine or food, such as those who have been told to carry an adrenaline shot sometimes called EpiPens or others who have had potentially fatal allergic reactions. The medical regulator also said vaccinations should be carried out only in facilities that have resuscitation equipment.

Such advice isn't uncommon; several vaccines already on the market carry warnings about allergic reactions, and doctors know to watch for them when people whove had reactions to drugs or vaccines in the past are given new products.

The two people who reported reactions were NHS staff members who had a history of significant allergies and carried adrenaline shots. Both had serious reactions, but recovered after treatment, the NHS said.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the regulator had done the right thing, but the general public shouldn't be worried about getting the vaccine.

For the general population, this does not mean that they would need to be anxious about receiving the vaccination," he said. One has to remember that even things like marmite can cause unexpected severe allergic reactions.

The warning comes just a day after Britain rolled out its mass vaccination programamid efforts to control a pandemic that has killed more than 62,000 people across the country. The MHRA gave an emergency authorization to the Pfizer-BioNtech vaccine last week, making Britain the first country to approve its widespread use. Canada's regulator authorized the vaccineWednesday.

Even in non-emergency situations, health authorities must closely monitor new vaccines and medications because studies in tens of thousands of people cant detect a rare risk that would affect 1 in 1 million. Authorities have not said how many people have received the shot in Britain so far, but they plan to give 800,000 doses in the first phase, which will target people over 80, nursing home staff and some NHS workers.

Late-stage trials of the vaccine found no serious safety concerns, Pfizer and BioNTech said. More than 42,000 people have received two doses of the shot during those trials.

Detailed data from the vaccine's trials showed potential allergic reactions in 0.63% of those who received the vaccine, compared with 0.51% of those who received the placebo. Reviewers from the U.S. Food and Drug Administration called this a slight numerical imbalance.

Documents published by the two companies showed that people with a history of severe allergic reactions were excluded from the trials, and doctors were advised to look out for such reactions in trial participants who werent previously known to have severe allergies.

As part of its emergency authorization for the vaccine, the MHRA required healthcare workers to report any adverse reactions to help regulators gather more information about safety and effectiveness.

The agency is monitoring the vaccine rollout closely and will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental, Powis said. The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.

Dr. June Raine, head of the medical regulatory agency, informed a Parliamentary committee about the reactions during previously scheduled testimony on the pandemic.

We know from the very extensive clinical trials that this wasnt a feature of the vaccine, she said. But if we need to strengthen our advice, now that we have had this experience in the vulnerable populations, the groups who have been selected as a priority, we get that advice to the field immediately.

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UK probing if allergic reactions linked to Pfizer vaccine - KING5.com