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With key approval, Pfizer vaccine accelerates towards emergency FDA approval

December 11, 2020

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The first COVID-19 vaccine expected to be deployed in the United States has gained the support of a panel of government advisers, a step that will likely help pave the way for emergency clearance by the Food and Drug Administration.

The Independent Vaccine Expert Committee voted 17 to 4, with one abstention, that the vaccine benefits from Pfizer Inc. and BioNTech SE outweigh the risks of use in persons 16 years of age and older. The FDA does not have to follow the recommendation, although it often agrees with its advisers.

An authorization could come from the FDA in a few days. This would open the doors for vaccine distribution across the United States, in a massive undertaking that will put healthcare workers and residents of long-term care facilities on the front lines, and mark a first step towards ending the process. ‘a pandemic that has killed an estimated 290,000 people in the United States

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Part of the group’s discussion focused on whether there was enough data to support the use of the vaccine in 16 and 17 year olds, leaving some pediatricians on the advisory committee uncomfortable. vote for it. However, other members said data from older trial participants could be extrapolated to younger people.

Pfizer stock rose 2.4% after the market closed in New York. Germany-based BioNTech’s US certificates of deposit rose 3%.

“We are happy with the strong majority vote, and if the FDA issues an authorization, be ready to bring this vaccine to Americans in an effort to help fight this devastating pandemic,” Pfizer CEO Albert Bourla said in a statement. declaration.

Clinical trial data submitted by companies and confirmed by FDA staff showed the vaccine to be 95% effective and to work well regardless of age, gender, race, ethnicity, or underlying conditions that lead to a high risk of symptoms serious cases of COVID-19.

There were eight cases of the virus in the group that received the vaccine and 162 in those who received a placebo, according to FDA staff. Pfizer has enrolled nearly 44,000 people in the trial.

Side effects from the shot were mild and developed more frequently in people aged 55 and under, with no signs of serious safety concerns based on two months of test data, FDA staff found. . Fatigue and headaches were among the most common reactions after the second injection. The vaccine uses a technology called messenger RNA that has never been used before in human vaccines.

States will make the final decisions about who gets vaccinated first, although counselors from the Centers for Disease Control and Prevention have recommended that health workers and residents of long-term care facilities be given priority.

The UK approved Pfizer’s shot earlier this month, but said people with a significant history of allergies should not take it after two people have experienced reactions. The FDA has asked Pfizer to assess reactions, including a severe form called anaphylaxis, as the shot is used in the United States, Susan Wollersheim, a doctor with the agency, said in a presentation to the committee. The agency continues to collect information and will closely monitor reactions “as a significant potential risk,” Wollersheim said.

Persistent problem

Paul Offit, a panel member, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, suggested that Pfizer study the use of the vaccine in people with severe allergies as he prepares to get full FDA approval if it gets emergency clearance.

“This problem will not die until we have better data,” he said.

The government is prepared with a safety monitoring system that will be put in place on the first day of the vaccination campaign, said Nancy Messonnier, director of the National Center for Vaccination and Respiratory Disease Prevention at the Centers for Disease Control and Prevention. . The CDC plans to work with the national academies of science, engineering, and medicine to assess safety concerns that may arise when the vaccine is used in the general population, she said.

Pfizer did not see any serious allergic reactions in its clinical trial, although the company is aware of the UK reports, said William Gruber, senior vice president of clinical vaccine research and development. Pfizer has provided the FDA with two months of post-vaccination safety data on clinical trial participants and will provide six months of that data when it seeks full vaccine approval.

Gruber said the company will seek full FDA approval in April. Until Pfizer receives full approval, the agency still considers the vaccine to be experimental and does not allow the company to market the product.

The FDA has asked vaccine manufacturers to continue studies comparing those who receive the vaccine to those who receive a placebo even after emergency clearance is given so that companies can gain full FDA approval. Demand can be difficult to meet as trial participants become eligible for vaccines and want protection instead of staying in the trial.

Marion Gruber (not related to William Gruber of Pfizer), head of the FDA’s Office of Vaccine Research and Review, said the agency was open to other approaches to collect more vaccine data to support full FDA approval.

There isn’t enough data on children under 16 to determine whether this will work in pediatric populations, FDA staff said. There are also insufficient data to make determinations on pregnant, lactating or immunocompromised persons.

Pfizer’s Gruber said the company plans to submit data on children ages 12 to 15 when it seeks full approval. Doran Fink, deputy director of the FDA’s clinical division of vaccines and related product applications, told agency advisers the agency expects developmental and toxicity data on vaccine use. in pregnant animals later this month.

Those who get vaccinated will still need to wear masks and practice social distancing to avoid spreading the disease. FDA staff said the shot prevents symptoms of COVID-19 but may not be as effective at preventing infections that do not show symptoms, meaning significant transmission would still be possible without health measures basic.

“At the moment, we have no evidence that this will have an impact on social life, on the epidemic,” said Patrick Moore, panel member and head of the cancer virology program at the Cancer Institute. from the University of Pittsburgh.

The CDC will conduct observational studies as the vaccine becomes available to the public to try to determine its effect on transmission, said Arnold Monto, chair of the expert panel and professor of epidemiology at the School. of Public Health at the University of Michigan.

‘Dramatic success’

If the vaccine is cleared by the FDA, Gustave Perna, the general responsible for rolling out the vaccine, said people would start getting the vaccine.96 hours, although Health and Human Services Secretary Alex Azar said it could happen within 24 hours. Between the Pfizer and Moderna vaccines, a maximum of 20 million people in the United States are expected to have received an injection in the two-dose schedule by the end of the year.

The editors of the New England Journal of Medicine, which published the pivotal vaccine study Thursday, called the results a triumph impressive enough to withstand any criticism imaginable.

“What appears to be a dramatic success for vaccination holds the promise of saving countless lives and enabling us to emerge from what has been a global catastrophe,” wrote Eric Rubin, editor of the journal, and Dan Longo, the deputy editor.