An independent advisory committee to the Centers for Disease Control and Prevention voted overwhelmingly on Saturday to recommend use of the Covid-19 vaccine made by Pfizer and BioNTech.
But the meeting also revealed an apparent divide in thinking on whether the vaccine should be given to people with a history of severe allergic reactions to other medicines, a determination that could prevent hundreds of thousands of people from receiving it.
During a presentation before the committee, a CDC official provided advisory language suggesting that any individual with a history of a severe allergic reaction to an injectable medication or vaccine should not receive the Pfizer/BioNTech product, which was granted emergency authorization by the Food and Drug Administration late Friday. Two health care workers in Britain experienced a severe reaction earlier this week after vaccinations started outside of clinical trials.
But the FDA, in issuing its emergency use authorization, only warned against using the vaccine in people who had previously had severe reactions to ingredients in this particular vaccine, not any vaccine or injectable drug.
Severe allergic reactions to vaccines are extremely rare and were also rare during the Pfizer and BioNTech trial, which excluded people with a history of the severe allergic reaction known as anaphylaxis. The FDA has released data indicating .63% of participants who received the vaccine experienced serious adverse reactions, compared to .51% of people who received a placebo.
In a press conference Saturday, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized that the FDA will continue to monitor the prevalence of severe allergic reactions associated with the Pfizer/BioNTech vaccine, and that it may need to revise its warnings moving forward.
He added, however, that the agency feels comfortable barring only those with a history of severe reactions to an ingredient in the vaccine, as opposed to barring all Americans with a history of any severe allergic reaction.
“It turns out about 1.6% of the population has had a severe allergic reaction of some sort or another to a food or some environmental aspect and we would really not like to have that many people not be able to receive the vaccine, so we looked very closely at the databases, and we feel comfortable that we’re telling people that unless they’ve had a severe allergic reaction to the vaccine, or one of its components, they can receive it,” Marks said. “We may have to modify things as we move forward, but for right now we’re comfortable with this.”
CDC officials expect to finalize their guidance on Sunday on who should receive the vaccine and how health care providers should discuss the risks with different groups of patients. Conflicting advice for those with a history of allergic reactions could create confusion as the first doses are delivered on Monday.
The discussion on severe reactions occurred during a marathon meeting of the CDC Advisory Committee on Immunization Practices, known as ACIP. The committee voted 11-0 to recommend vaccination for people age 16 and older; three members recused themselves because of participation in the vaccine trials or other conflicts.
On the question of allergic reactions, some committee members raised questions about how the language would be understood by the public, as providers and ordinary citizens may have a different understanding of what constitutes a severe allergic reaction. Others raised questions about whether the language was overly broad and would be needlessly applied to people with food and environmental allergies.
“I recognize the rationale for including this, but I am a little nervous about the abundance of caution,” said committee member Beth Bell, a physician and professor of global health at the University of Washington. “I’m wondering if there could be further clarification…so there’s a clear distinction between what we’re concerned about and this much broader group of allergies that involves an awful lot of people who don’t need to be included in this.”
A CDC official replied that Bell’s suggested distinction would be added to the agency’s advisory language.
The discussion, coming shortly before the first doses are delivered, underscored the breakneck pace at which federal officials are working to finalize guidelines on who should receive the vaccine amid unclear clinical evidence.
The two British health care workers who had reactions had previously experienced anaphylaxis because of food allergies, but it is not known whether an ingredient in the vaccine caused the reactions. An investigation is ongoing.
In considering other groups, the advisory committee members broadly agreed there is no evidence to suggest that women who are breastfeeding should not receive the vaccine; they also agreed that women who are pregnant may receive the vaccine after discussing the risks and benefits with their doctors.
There was some debate on the evidence of safety for 16- and 17-year-olds. Henry Bernstein, a pediatrician and professor at the Zucker School of Medicine at Hofstra University, suggested that 16 and 17 year olds should be designated as a “special population” to recognize that data is limited in that age group.
“A successful pediatric vaccination program depends on creating and sustaining parental confidence in both the safety and effectiveness of this vaccine,” he said.
Other panel members disagreed, noting the trial produced no evidence of safety concerns in that age group.
Even with uncertain evidence in some patient groups, committee members agreed that the benefits of the vaccine outweigh the risks and that it should be distributed broadly. Some members said they were concerned that distribution by state and local officials is being underfunded and urged that federal officials allocate more resources to that effort.
“I want to re-emphasize the need for substantially increased government funding to actually implement this recommendation,” said committee member Peter Szilagyi, a pediatrician at UCLA. “We’re going to have tough and sad times ahead because of the surge and the limited vaccine supply, but I am hopeful that this is the beginning of the end of the coronavirus pandemic.”
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i had the flu vaccine, ten years ago . i had a sever reaction, they had to run and injected me with the epi pen. can i get this vaccine?
Always asked who is the maker of your flu vaccine. Maybe with other companies, your will not have severe reactions.
I have anaphylaxis after taking levequin antibiotic (twice). Should I take the Pfizer vaccine?
Joel, the same happened to be after taking Levequin a few years ago and I am wondering the same thing
I was born with severe allergies including many foods and pollen. I grew out of the the effects of allergies and eat all foods. I never had an effect of a vaccine. Should I not get the COVID 19 vaccine? Recommendations need to be more specific!
Does the COVID-19 shot contain penicillin I’m allergic to penicillin
They say people shouldn’t be given the vaccine if they’re allergic to it or any of it’s ingredients. What the hell kind of a jackass statement is THAT ? How do tou know if you’re allergic to it without ever having been inoculated with it ? OR how the hell do you know whether or not you’re allergic to any one or more if it’s ingredients if they don’t list what the ingredients are ? You’re causing confusion and panic you dirty son of a bitch bastards.
They are not causing confusion or panic. Two people given the Pfizer vaccine develop anaphylaxis, fortunately they carry with them something like epipens, otherwise they may be the first known deaths from the vaccine.
Pfizer did not test the vaccine on people with food allergy, so probably no what knows for now how these batch of people will react. Pfizer and Moderna did not monitor how many vaccinated people become asymptomatic, so I am not sure how they arrived at 95% percent effectiveness if they did not test how many become asymptomatic after getting vaccinated.
Maybe they will make the world population as the final trial field. I am not confident in getting vaccinated by these two companies vaccine. Anyway since it is not 100%, that mean whoever get vaccinated cannot relax the safety measure they were doing before getting vaccinated. Who knows who will fall on that 5 or more percent.
Maybe it is more worthwhile to wait for a vaccine with more data. AztraZenaca has lower success rate but more data. They also have more data on how many people become asymptomatic.
Why should one entrust my life on a vaccine with very limited data if they precaution they are taking to avoid covid19 is working. Health Care people are getting covid19 in workplace because they are not train how to properly wear PPE and decontaminate themselves. Sometimes, they don’t even have the right PPE. I hope getting vaccinated will not give people false hope that they will never get covid19 and stop protecting themselves.
I have an aversion to abortion and will not allow myself to be injected with aborted baby cells or poison such as mercury and aluminum.
I would rather suffer and die from the virus than stand before God someday and answer for allowing my body to be injected with the cells of murdered babies or known poisons.
Then you should avoid using cosmetics and beauty product, some of them uses some ingredients from those “murdered babies” and its byproducts.
Some people feel strongly about a cause but then on their private life they are buying and using things that they strongly oppose. Just look at the climate change people.
I have allergies to foods and several medications including penicillin, sulfur drugs, aspirin, and anti-inflammatory drugs. I have also had severe reactions after getting into flu shots. I would like to know if any of the vaccine ingredients are similar to these allergens.
there is sulpur in it. im allergic to sulfur.
I have environmental and food allergies. How do I find out that the ingredients are of the Covid vaccine to make sure it is safe for me?
I take a medication 💊called xolier for allergies Asthma and hives what about me
I found the ingredients online however there is something in the secret sauce they aren’t revealing. I’m allergic to just everything under the sun. Some are mild and sometimes require the epi-pen. I’m passing on the vaccine for now until more information is known. I’m retired and have only used 1/4 tank of gas since March and enjoying my quiet time.
While American doctors with 2000 medical papers to their credit try to get the government to acknowledge the IMASK+ covid protocol that front line doctors are proving works is cheap and I beleive much safer.
https://covid19criticalcare.com/
It now appears that Pfizer did not test the vaccine on people with food allergy. It was also on the news that AztraZeneca found that some people who got vaccinated end up getting infected but asymptomatic, maybe that is why their effective rate is 70 % versus Pfizer and Moderna 95%. It was on some papers that the other two companies did not do testing on volunteers on whether they become asymptomatic after getting vaccinated. If they do that, the effective rate would go down.
I would rather take a vaccine with a lower success rate than a vaccine not does not give data on how they arrive at 95% success rate. Data about the trials should be made public but it seems that the two companies rush the development of the vaccine, bypassing testing on people who have allergy or maybe other medical conditions. Test on whether some people become asymptomatic is also not done. What else was eliminated during the trials of the vaccine. With so many unknown about the trials data, I would not feels confident in deciding that I should get these two companies vaccine.
We don’t want to create more asymptomatic people that feel that they have the vaccine and will get infected. That is a very dangerous scenario since this people will not get tested but can go on infecting others.
Corrections:
We don’t want to create more asymptomatic people that feel that got vaccinated and will get not infected anymore. This is a very dangerous scenario since this people will not get tested but can go on infecting others.
https://covid19criticalcare.com/
There are options.https://covid19criticalcare.com/