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2 folks had extreme allergic reactions after getting Covid vaccine

2 people had severe allergic reactions after getting Covid vaccine

Empty vials containing a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus lie on a table as South Africa resumes its vaccination campaign at Klerksdorp Hospital on February 18, 2021.

Phill Magakoe | AFP | Getty Images

Two study participants suffered severe allergic reactions shortly after receiving the Covid-19 vaccine from Johnson & Johnson, a J&J scientist told an FDA panel on Friday.

J&J was first briefed on the allergic reactions on Wednesday, Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J&J, Janssen, told the FDA’s Advisory Committee on Vaccines and Related Biological Products.

One of the people took part in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction, after receiving the vaccine.

She did not provide details on the second person’s reaction.

“We will continue to monitor these events closely,” she told the panel.

To date, there have been no reports of anaphylaxis in J & J’s clinical study. The Centers for Disease Control and Prevention is currently overseeing events such as the introduction of Pfizer and Moderna vaccines by states and pharmacies.

There were 46 reports of anaphylaxis in patients who received Pfizer’s vaccine and 16 cases in patients who received Moderna’s vaccine, according to a CDC report released on February 16. The agency said the incidence of the reaction is within the range of cases reported for the influenza vaccine.

The CDC urges healthcare providers to monitor patients for 15 minutes after vaccination and for 30 minutes for patients with a history of allergic reactions.

If someone has a severe allergic reaction after the first dose of the Covid-19 vaccine, the CDC recommends not receiving the second dose, even if the allergic reaction wasn’t severe enough to require emergency care.

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Covid-Linked Syndrome in Kids Is Rising, and Instances Are Extra Extreme

Covid-Linked Syndrome in Children Is Growing, and Cases Are More Severe

“We’re getting more of these MIS-C kids now, but this time it just seems like a higher percentage of them are really seriously ill,” said Dr. Roberta DeBiasi, Infectious Disease Director at Children’s National Hospital in Washington. DC During the first wave of the hospital, roughly half of the patients needed intensive care treatment, but now 80 to 90 percent do.

The reasons are unclear. The surge follows the general surge in Covid cases in the US after the winter holiday season, and more cases can simply increase the likelihood of serious illnesses occurring. So far, there is no evidence that newer coronavirus variants are responsible, and experts say it is too early to speculate on the effects of variants on the syndrome.

The condition remains rare. The latest numbers from the Centers for Disease Control and Prevention show 2,060 cases in 48 states, Puerto Rico and the District of Columbia, including 30 deaths. The mean age was 9 years, but infants up to 20 years of age were affected. The data, which are not complete until mid-December, show that the case rate has increased since mid-October.

While most young people, including those who became critically ill, survived in relatively healthy condition and went home, doctors are not sure if they will experience persistent heart or other problems.

“We really don’t know what’s going to happen in the long run,” said Dr. Jean Ballweg, Medical Director of Pediatric Heart Transplant and Advanced Heart Failure at the Children’s Hospital and Medical Center in Omaha, Neb., Where April through October. The hospital treated about two cases a month, about 30 percent of them in intensive care. That rose to 10 cases in December and 12 in January, with 60 percent requiring intensive care – most of the ventilators needed. “Obviously they seem sicker,” she said.

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Roche arthritis drug reduces loss of life in hospitalized sufferers with extreme Covid, Oxford researchers say

Roche arthritis drug reduces death in hospitalized patients with severe Covid, Oxford researchers say

A pharmacist shows a box of tocilizumab, which is used to treat rheumatoid arthritis, in the pharmacy of Cambrai Hospital in France on April 28, 2020.

Pascal Rossignol | Reuters

A drug used to treat people with rheumatoid arthritis appears to reduce the risk of death in hospitalized patients with severe Covid-19, especially when combined with the steroid dexamethasone, Oxford University researchers said Thursday.

Oxford researchers found that the drug tocilizumab, an intravenous drug of A department of the Swiss drug manufacturer Roche also shortened the length of stay for patients in hospitals and reduced the need for a ventilator. The study was part of the recovery study, which has tested a number of potential treatments for Covid-19 since March.

“Previous studies of tocilizumab had shown mixed results and it was unclear which patients might benefit from the treatment,” said Peter Horby, professor at Oxford University and co-investigator for the recovery study, in a statement. “We now know that tocilizumab benefits apply to all COVID patients with low oxygen levels and significant inflammation.”

A total of 2,022 patients were randomly selected to receive tocilizumab, sold under the brand name Actemra, by intravenous infusion and compared to 2,094 patients who were randomly selected to receive standard care alone. The researchers said 82% of patients were also taking a steroid like dexamethasone, another drug that was found to reduce deaths in the sickest Covid-19 patients.

Researchers said 596 patients in the tocilizumab group died within 28 days, compared with 694 patients in the standard care group. That means that for every 25 patients treated with tocilizumab, “an extra life would be saved,” said Oxford researchers.

The drug increased the chances of being discharged from 47% to 54% within 28 days, the researchers said. The benefits have been seen in all patients, including those who need mechanical ventilators in an intensive care unit, they added. In patients who were not given a ventilator prior to the start of the study, tocilizumab reduced the chance of getting invasive mechanical ventilation or death from 38% to 33%, the researchers said.

The researchers said that using tocilizumab in combination with dexamethasone reduced mortality by about a third in patients who require oxygen and by almost half in patients who require a ventilator.

The results of the Oxford study have not yet been published in a peer-reviewed journal.

Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to end the pandemic that, according to Johns, will infect more than 107.4 million people in just over a year and has killed at least 2.3 million people at Hopkins University.

In the US, the Food and Drug Administration has approved Gilead Sciences’ antiviral drug Remdesivir for the treatment of Covid-19 patients who are 12 years or older and require hospitalization.

The FDA has approved the use of two monoclonal antibody treatments as well as two vaccines – from Pfizer and Moderna. A third vaccine from Johnson & Johnson is expected to receive FDA approval as early as this month.

The Covid-19 Therapy Randomized Evaluation, or Recovery Study, was launched in March by researchers at Oxford University to find treatments for Covid-19. The study previously showed that hydroxychloroquine, lopinavir ritonavir, azithromycin, and convalescent plasma had no benefits for patients hospitalized with Covid-19.

The study is currently investigating aspirin, the anti-inflammatory drugs baricitinib and colchicine, and Regeneron’s antibody cocktail.

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Which Covid Vaccine Ought to You Get? Specialists Weigh the Impact Towards Extreme Illness

Which Covid Vaccine Should You Get? Experts Weigh the Effect Against Severe Disease

At first glance, the results reported on Friday of the long-awaited study of Johnson & Johnson’s coronavirus vaccine may have been disappointing. Overall effectiveness – the ability to prevent moderate and severe illnesses – was reported at 72 percent in the United States, 66 percent in Latin American countries, and 57 percent in South Africa.

These numbers are well below the high bar set by Pfizer-BioNTech and Moderna, the first two emergency vaccines approved in the United States, which had an overall effectiveness of 94 to 95 percent.

Dr. Anthony S. Fauci, the nation’s leading infectious disease expert and now President Biden’s leading medical advisor on the coronavirus pandemic, acknowledged the remarkable difference at a briefing Friday.

“If you woke up and say, ‘Well, go to the left door and you get 94 or 95 percent, go to the right door and you get 72 percent. ‘Which door do you want to go to? ”He asked.

Dr. However, Fauci said the most important measure is the ability to prevent serious illness, which means keeping people out of the hospital and preventing deaths. For Johnson & Johnson, that result was 85 percent in all of the countries it was tested in, including South Africa, where a rapidly spreading variant of the virus had shown some ability to evade vaccines.

More important than preventing “some pain and a sore throat,” said Dr. Fauci, is the defense against serious illnesses, especially in people with underlying diseases and in older adults who are more likely to become seriously ill and die of Covid. 19th

“If you can prevent serious illness in a high percentage of people, it will soothe the stress of human suffering and death in this epidemic that we are seeing it right now,” said Dr. Fauci, “As we know, over the past few weeks our healthcare system has been burdened by the number of people requiring hospitalization and intensive care.”

Dr. Francis Collins, director of the National Institutes of Health, compared the ability to prevent serious illness to the effects of flu vaccinations, which may not always prevent influenza completely, but make it less severe.

“The same seems to be true here, in circumstances where this variant clearly makes it a little harder to get the most forceful response you want,” said Dr. Collins. “But it still looks very good for serious illnesses.”

The Moderna vaccine also showed high 100 percent effectiveness against serious illnesses. The Pfizer BioNTech appeared to be too, but the total number of severe cases in the study was too few to be certain.

However, the researchers caution that trying to compare effectiveness between new and previous studies can be misleading because the virus is developing quickly and the studies have to some extent examined different pathogens.

“You have to realize that Pfizer and Moderna had an advantage,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University, in an interview. “They did their clinical studies before the variant strains became very clear. Johnson & Johnson not only tested their vaccine against the standard strain, but they also had the variants. “

The best way to stop the spread of mutants and prevent new ones from emerging is to vaccinate as many people as you can as soon as possible, says Dr. Fauci and other researchers. Viruses can’t mutate if they can’t replicate, and they can’t replicate if they can’t get into cells. Keeping them away from people by immunizing them can kill the process.

In addition to the Pfizer BioNTech and Moderna vaccines already in use in the US, three more may soon be available: those made by Novavax, Johnson & Johnson and AstraZeneca. AstraZeneca’s vaccine has already been approved in the UK and other countries.

Globally, the Johnson & Johnson vaccine is expected to play an important role, especially in low- and middle-income countries, as it works after just one shot, is relatively inexpensive, and is easier to store and distribute than Pfizer-BioNTech’s manufactured vaccines and Moderna, as it does not share their strict requirements for freezing and chilling.

People waiting to be vaccinated may wonder if they will be able to choose vaccines and if they should hold out and wait until the one that looks best to them becomes available.

Covid19 vaccinations>

Answers to your vaccine questions

Am I eligible for the Covid vaccine in my state?

Currently more than 150 million people – almost half of the population – can be vaccinated. But each state makes the final decision on who goes first. The country’s 21 million healthcare workers and three million long-term care residents were the first to qualify. In mid-January, federal officials asked all states to open eligibility to anyone over the age of 65 and adults of any age with medical conditions that are at high risk of becoming seriously ill or dying of Covid-19. Adults in the general population are at the end of the line. If federal and state health authorities can remove bottlenecks in the distribution of vaccines, everyone over the age of 16 is eligible as early as spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It can take months before a vaccine is available to anyone under the age of 16. For the latest information on vaccination guidelines in your area, see your state health website

Is the Vaccine Free?

You shouldn’t have to pay anything out of pocket to get the vaccine, despite being asked for insurance information. If you don’t have insurance, you should still get the vaccine for free. Congress passed law this spring banning insurers from applying cost-sharing such as a co-payment or deductible. It consisted of additional safeguards prohibiting pharmacies, doctors, and hospitals from charging patients, including uninsured patients. Even so, health experts fear that patients will end up in loopholes that make them prone to surprise bills. This could be the case for people who are charged a doctor’s visit fee with their vaccine or for Americans who have certain types of health insurance that are not covered by the new regulations. If you received your vaccine from a doctor’s office or emergency clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise invoice, it is best to get your vaccine at a Department of Health vaccination center or local pharmacy as soon as the shots become more widely available.

Can I choose which vaccine to get?How long does the vaccine last? Do I need another next year?

That is to be determined. It is possible that Covid-19 vaccinations will become an annual event just like the flu vaccination. Or the vaccine may last longer than a year. We’ll have to wait and see how durable the protection from the vaccines is. To determine this, researchers will track down vaccinated people to look for “breakthrough cases” – those people who get Covid-19 despite being vaccinated. This is a sign of a weakening of protection and gives researchers an indication of how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of people who have been vaccinated to see if and when a booster shot might be needed. It is conceivable that people might need boosters every few months, once a year, or just every few years. It’s just a matter of waiting for the data.

Does my employer need vaccinations?Where can I find out more?

Dr. Paul Offit, a vaccines expert at Philadelphia Children’s Hospital, told CNN that Pfizer-BioNTech and Moderna vaccines would be his first choice when they were abundant because of their higher overall effectiveness.

But right now there aren’t enough of these vaccines.

If he couldn’t get the Pfizer BioNTech vaccine or the Moderna vaccine, he would do the Johnson & Johnson shot, said Dr. Offit – as long as the data the company will submit to the Food and Drug Administration looks as good as the company reported on Friday.

He said Johnson & Johnson’s Serious Disease Reduction Report was a strong selling point.

“That’s what you want,” said Dr. Offit. “You want to stay out of the hospital and out of the morgue.”

He noted that the company was also investigating a two-shot regimen that could increase its effectiveness.

People taking the Johnson & Johnson vaccine should be able to safely get a Pfizer BioNTech or Moderna vaccine later if a booster shot is needed, he said.

Dr. Schaffner said he had just attended a meeting with other public health experts and they asked each other what they would say to their spouses or partners if they could get the Johnson & Johnson vaccine tomorrow or had to wait three weeks Pfizer- BioNTech’s or Moderna’s.

“We all said, ‘Get it tomorrow,” said Dr. Schaffner. “The virus is bad. You risk another three weeks of exposure instead of receiving protection tomorrow.”

He said the 85 percent effectiveness of Johnson & Johnson against serious illnesses is a little less than that reported by Moderna and Pfizer-BioNTech, “but it’s still damn high.”

It is not yet known whether it is safe to take a different type of vaccine every now and then, said Dr. Schaffner, adding, “We haven’t investigated this.”

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Research Says Blood Plasma Reduces Threat of Extreme Covid-19 if Given Early

Study Says Blood Plasma Reduces Risk of Severe Covid-19 if Given Early

It will be difficult “to find and diagnose them in this vanishingly small window,” said Dr. Ilan Schwartz, an infectious disease doctor at the University of Alberta who was not involved in the study. “The study looks solid, but it isn’t exactly practical in the real world.”

Plasma has additional logistical hurdles, said Dr. Titanji from Emory University. Treatment is given as an intravenous infusion – a process that requires skilled hands – and patients must be monitored afterward. That might be easier in long-term care facilities, but far more difficult for the general population, she said.

And plasma may not work as well as monoclonal antibody therapy – a synthetic preparation that is made en masse in the laboratory and not drawn from human blood, and that focuses on only one or two types of antibody at a time, rather than the total amount produced naturally by the immune system. Two types of monoclonal antibody treatments have been approved for emergencies in Covid patients.

But plasma has some advantages over monoclonal antibody treatments, emphasized Dr. Polack.

Because monoclonal antibodies are synthetic and tedious to make, they come at a high price, sometimes costing thousands of dollars (although the US government has prepaid some doses). The limited supply chain of treatment, as well as unexpectedly low demand, have made it inaccessible to many patients in need in the US and abroad.

In countries like Argentina, plasma could be one of the best treatment options available, said Dr. Polack. Plasma infusions in Buenos Aires cost less than $ 200 per patient. “It’s more accessible, cheaper, more universal,” he said.

Even in the United States, plasma “really is the only game in town that is widely available in terms of antibody therapy,” said Dr. Wang from Stanford.

Instead of viewing monoclonal antibodies as an upgrade for convalescent plasma, “they each have a different place in the armory,” said Dr. Pirofski. “Anything this virus can control is really an incredible benefit at this point.”

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Small Variety of Covid Sufferers Develop Extreme Psychotic Signs

Small Number of Covid Patients Develop Severe Psychotic Symptoms

Brain scans, spinal fluid analyzes, and other tests did not reveal any brain infection, said Dr. Gabbay, whose hospital has treated two patients with postcovid psychosis: a 49-year-old man who heard voices believing he was the devil and a 34-year-old woman who started carrying a knife, undressing in front of strangers, and putting in hand sanitizer to give her food.

According to reports, most of these patients did not get very sick from Covid-19. The patients Dr. Goueli did not have any breathing problems, but they had subtle neurological symptoms such as hand tingling, dizziness, headache, or decreased odor. Then, two weeks to a few months later, they develop “this profound psychosis that is really dangerous and scary for everyone around them”.

It is also noticeable that most of the patients were between 30, 40 and 50 years old. “It is very rare for you to develop this type of psychosis in this age group,” said Dr. Goueli, since such symptoms are more likely to be associated with schizophrenia in young people or dementia in older people. And some patients – like the physiotherapist who took herself to the hospital – understood that something was wrong, while “people with psychosis usually don’t know that they have lost touch with reality”.

Some post-Covid patients who developed psychosis had to be hospitalized for weeks, where doctors tried different drugs before they found one that worked.

Dr. Robert Yolken, a neurovirology expert at the Johns Hopkins University Medical School in Baltimore, said that while people can physically recover from Covid-19, in some cases their immune systems may not be able to turn off or due to “Delayed elimination of a small amount of virus. “

Persistent immune activation is also one of the main explanations for brain fog and memory problems that plague many Covid survivors, and Emily Severance, a schizophrenia expert at Johns Hopkins, said that post-Covid cognitive and psychiatric effects may be due to “something similar in the brain “Are due.

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Boston Physician Develops Extreme Allergic Response After Getting Moderna Vaccine

Boston Doctor Develops Severe Allergic Reaction After Getting Moderna Vaccine

Moderna’s vaccine, like Pfizer’s, is based on a molecule called messenger RNA, or mRNA, that is injected into the upper arm. Once inside human cells, the mRNA directs the production of a protein called spike, which teaches the immune system to recognize and thwart the coronavirus should it ever enter the body. Each vaccine contains a handful of other ingredients that wrap the fragile mRNA in a protective fat bubble and help keep the prescription stable during transit.

None of the ingredients in any of the vaccines have been identified as common allergens. However, several experts have cautiously pointed to polyethylene glycol or PEG, which appears as a possible culprit in both recipes, albeit in slightly different formulations. PEG is found in a wide variety of pharmaceutical products, including ultrasound gel, laxatives, and injectable steroids, and allergies to it are extremely rare.

Dr. Kuruvilla said it was still possible that something else was responsible and more research was needed to determine the cause of these events.

Dr. Kimberly Blumenthal, an allergist and immunologist at Massachusetts General Hospital, noted that anaphylaxis is sometimes difficult to confirm without blood tests looking for an enzyme called tryptase, which is released in allergic reactions. It is important that logs are in place so that similar cases can be investigated further.

Based on data obtained from late-stage clinical trials, Moderna has not reported any associations between vaccine and anaphylaxis. When products from closely monitored studies become widely available, rare side effects may occur.

The recent allergic reactions related to Pfizer’s very similar vaccine sparked heated discussion during the FDA and CDC panel discussions earlier this month. Experts noted that anaphylaxis was becoming unusually common this soon. (Under normal circumstances, allergic reactions to vaccines are believed to occur at the rate of about one in a million.)

Denise Grady and Noah Weiland contributed to the coverage.

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Moderna Vaccine Is Extremely Protecting and Prevents Extreme Covid, Knowledge Present

Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show

WASHINGTON – Newly released data confirmed on Tuesday that Moderna’s coronavirus vaccine offers high levels of protection and sets the stage for this week’s emergency approval from federal regulators and beginning its spread across the country.

The Food and Drug Administration intends to approve use of the vaccine on Friday, said people familiar with the agency’s plans. The decision would give millions of Americans access to a second coronavirus vaccine as early as Monday.

The FDA review confirms Moderna’s earlier assessment that the vaccine had an efficacy rate of 94.1 percent in a study of 30,000 people. Side effects, including fever, headache, and fatigue, were uncomfortable but not dangerous, the agency found.

The success of Moderna’s vaccine has become all the more important to fighting the pandemic as other vaccine efforts have stalled. The hopeful news comes at a time with a record number of coronavirus cases overwhelming hospitals and an ever-increasing death toll that hit a bleak milestone of 300,000 on Monday.

The data release is the first step in a public review process that includes a one-day meeting on Thursday by an independent panel of experts. You will hear from Moderna, FDA scientists, and the public before they vote on whether to recommend approval. The panel is expected to vote yes and the FDA generally follows the experts’ recommendations.

Distribution of about six million doses could then begin next week, significantly adding to the millions of doses already developed by Pfizer and BioNTech, the companies that only released the first emergency coronavirus vaccine last Friday . Healthcare workers received the first shots of the Pfizer BioNTech vaccine Monday with an efficacy rate of 95 percent.

The introduction of vaccines has been eagerly anticipated and is one of the most ambitious vaccination campaigns ever carried out in the United States.

Last summer, the federal government signed contracts with Moderna and Pfizer to dispense a total of 200 million cans in the first quarter of 2021. Since both vaccines require two doses, these contracts guaranteed enough doses for 100 million people.

Last week the government announced that it had bought an additional 100 million doses of Moderna for the second quarter, bringing the number of Americans who can be vaccinated to 150 million. That leaves the question of how and when the 180 million or so other Americans will be covered.

Both vaccines are made available to the public free of charge.

Moderna’s vaccine has become a symbol of government scientists’ successes during the pandemic. After China released the genetic sequence of the new virus in early January, scientists from Moderna and the National Institutes of Health were able to focus on designing a vaccine in just two days. Unlike Pfizer, Moderna has a close relationship with Operation Warp Speed, the federal program that seeks to get a vaccine to market quickly. Nearly $ 2.5 billion federal funding helped Moderna buy raw materials, expand its factory, and increase its workforce by 50 percent.

Moderna’s success contrasts with two other high profile projects the US had hoped would increase vaccine supply: one from pharmaceutical companies Sanofi from France and GlaxoSmithKline from the UK and one from Anglo-Swedish drug maker AstraZeneca and the Oxford University.

AstraZeneca and Oxford used two different doses in clinical trials in the UK and Brazil. The effectiveness was 62 percent at one level and 90 percent at the other. These jumbled results have made it unclear when AstraZeneca will have enough data to obtain an emergency clearance.

Meanwhile, Sanofi and GlaxoSmithKline received disappointing results with their vaccine in early clinical trials. While it produced a promising immune response in volunteers under the age of 50, it did not do so in older people. The companies are now planning a series of new studies with a different version of the vaccine. Due to the delay, they are unlikely to provide vaccines before the end of 2021.

Moderna’s vaccine worked equally well in white volunteers and in color communities. There was also no significant difference between protecting men and women or between healthy volunteers and those at risk for severe Covid-19 who developed conditions such as obesity and diabetes. For people aged 65 and over, the study found an estimated effectiveness of 86.4 percent, which is below the overall estimate of 94.1 percent. However, the apparent difference was not statistically significant.

So far, FDA reviews have shown two possible differences between vaccines, but the results may reflect a lack of data more than real differences. The Pfizer BioNTech study showed that the vaccine began protecting against the coronavirus within about 10 days of the first dose. The experiment with the vaccine from Moderna, however, did not show such a noticeable effect after the first dose.

However, in the early days of the Moderna study, there were fewer cases of Covid-19 among study participants, making it more difficult to measure the differences between the vaccinated group and the placebo group. In either case, health officials have said that for both vaccines, two doses are essential for complete protection.

Updated

Dec. 15, 2020 at 9:31 am ET

A second difference concerns the ability to prevent serious diseases. Moderna presented more evidence that its vaccine can, according to the review. In his study, 30 volunteers developed severe cases of Covid. All of them belonged to the placebo group, with no cases among the vaccinated people.

In the Pfizer BioNTech study, the results were less convincing. There were 10 severe cases in the placebo group and one in the vaccinated group. These numbers are too few to assess the vaccine’s ability to prevent serious diseases.

“The data available for these results did not allow firm conclusions,” said the FDA.

The documents released on Tuesday made it clear that side effects were particularly common after the second dose, but usually lasted only one day. Experts say people may need to take a day off after the shot.

During the Moderna trial, researchers also kept an eye out for volunteers who developed new disorders. In a multi-month study of 30,000 volunteers, it is normal for some to have conditions unrelated to the vaccine, health experts say. Comparing the rates between people receiving the vaccine and placebo, as well as general background rates, can help identify serious concerns and eliminate coincidences.

During the Moderna study, three vaccinated participants developed a form of temporary facial paralysis called Bell’s palsy, while one participant on the placebo experienced the same. Bell’s palsy, which can last weeks or longer, can be triggered by viral infections and other causes. Around 40,000 people develop the disease in the United States each year. Years of intensive research have found no evidence that any vaccine routinely recommended in the US causes Bell’s palsy.

In the review released Tuesday, the FDA said, “There is insufficient information currently available to establish a causal relationship with the vaccine.”

The Pfizer BioNTech study identified four cases in the vaccine group, including one in a person with a history of the disorder and none in the placebo group.

Dr. Peter Marks, the FDA’s lead vaccine regulator, said in an interview with JAMA Monday that the cases of Bell’s palsy in the study were most likely not caused by the vaccine and that the apparent difference between the two groups of volunteers was only one reason Random question.

“Our working hypothesis is just that this is an imbalance in the background rates, as we’ve seen in other studies,” he said.

In its analysis of the Moderna vaccine released Tuesday, the FDA said it plans to recommend prosecuting Bell palsy cases when the vaccines are rolled out.

“We’re going to ask about this just to wrap up that question,” said Dr. Marks on Monday.

The FDA’s analysis did not reveal any serious allergic reactions to the Moderna vaccine. The same was true for the Pfizer-BioNTech clinical trial, but when vaccinations began in the UK outside of that study, two people with a history of serious allergies had a severe and potentially life-threatening reaction called anaphylaxis.

UK health officials have said people with a history of anaphylaxis should avoid the Pfizer BioNTech vaccine.

In the United States, the Centers for Disease Control and Prevention has stated that people with serious allergies can be safely vaccinated, with close monitoring for 30 minutes after receiving the shot.

Moderna and Pfizer-BioNTech vaccines are similar in their ingredients, but not identical. Therefore, it is not clear whether an allergic reaction to one vaccine would occur with the other. Both are made up of genetic material called mRNA that is enclosed in a bladder made of a mixture of fats. The two companies use different fats.

Moderna has applied for approval to vaccinate people aged 18 and over, as in its study. The Pfizer BioNTech vaccine was approved for people aged 16 and over because the study included a number of younger volunteers. Both companies are conducting experiments with children aged 12 and over and plan to also study younger children.

Sharon LaFraniere contributed to the coverage.

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