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Pfizer Vaccine Gets FDA Panel Review as Clearance Decision Nears

An illustration of the Covid-19 virus during a virtual public meeting of the U.S. Food and Drug Administration (FDA) in Tiskilwa, Illinois, U.S., on Thursday, Dec. 10, 2020. The Covid-19 vaccine developed by Pfizer and BioNTech meets the requirements for an emergency-use authorization set out by the FDA according to a 92-page staff report analyzing the companies' clinical development program. Photographer: Daniel Acker/Bloomberg

(Bloomberg) --The first Covid-19 vaccine expected to be deployed in the U.S. is under the microscope as a panel of government advisers began considering whether to recommend the shot for emergency-use authorization.

By Anna Edney
Dec 10, 2020, 6:55 PM – Updated on Dec 10, 2020, 10:01 PM
Word Count: 862
A Food and Drug Administration advisory panel gathered Thursday to consider issues including the safety of the shot from Pfizer Inc. and BioNTech SE, which employs a technology called messenger RNA that’s never before been used in human vaccines.

The government is prepared with a safety monitoring system that will go into place the first day of the immunization campaign, said Nancy Messonnier, director of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

“Vaccine safety and effective monitoring are a top priority for the U.S. government,” she told the panel in the online meeting. The CDC is considering working with the National Academy of Sciences, Engineering and Medicine to evaluate safety issues that may arise when the vaccine is in use in the general population, she said.

The panel will vote at the end of the meeting on whether the benefits of Pfizer’s vaccine outweigh the risks. The FDA doesn’t have to follow the recommendation, though often it does agree with its advisers.

Covid Deaths Surging
An expected positive vote later Thursday would move the experimental vaccine and shots will be distributed across the U.S. in a massive undertaking that will put health-care workers and long-term care facility residents at the front of the line. The U.S. government expects about 2.9 million doses to be available to states immediately.

The FDA advisers, a group of independent vaccine experts, will discuss Pfizer and BioNTech’s clinical trial data, which the agency confirmed showed the shot was 95% effective and worked well regardless of age, gender, race, ethnicity or underlying conditions that cause people to be at high risk of severe Covid-19 symptoms. The vaccine is expected to be the first made available in the U.S., where about 290,000 people have died from the virus.

Read More: Pfizer Shot Effective, Safe, FDA Staff Says Before Meeting (3)

Side effects were mild and developed more frequently in those aged 55 and younger, with no signs of serious safety concerns based on two months of trial data. After the second injection, fatigue and headache were among the most common reactions.

The messenger RNA technology prompts the body’s cells to make proteins that induce an immune response that can be repeated if a real infection occurs. Moderna Inc. also makes an experimental Covid-19 vaccine based on messenger RNA and the FDA advisory committee is scheduled to meet Dec. 17 to discuss whether the agency should grant it emergency authorization.

Among participants in the Pfizer clinical trial who didn’t show signs of Covid-19 infection during vaccination, there were eight virus cases within the group who received the shot and 162 in those who got a placebo, according to FDA staff. Pfizer enrolled almost 44,000 people in the trial.

If Pfizer’s vaccine is cleared by the FDA, Gustave Perna, the general leading the vaccine rollout, said people would begin to get shots within 96 hours, though Health and Human Services Secretary Alex Azar has said it could occur within 24 hours. Between Pfizer and Moderna’s vaccines, 20 million people in the U.S. are expected to have received one shot in the two-dose regimen by the end of the year. Vaccines from AstraZeneca Plc and its partner University of Oxford as well as Johnson & Johnson could become available next year.

‘Dramatic Success’
States will make the final decisions about who gets the vaccines first, though advisers to the Centers for Disease Control and Prevention have recommended health-care workers and long-term care facility residents be prioritized. The U.K. approved Pfizer’s shot earlier this month and Canada cleared the vaccine Wednesday. The vaccine is also under review in the European Union.

Pfizer provided the FDA two months of post-vaccination safety data on clinical trial participants and will provide six months of such data when it applies for full approval of the shot. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, said the company will apply for full FDA approval in April. Until Pfizer receives full approval, the FDA still considers the vaccine experimental and does not allow the company to market the product.

Read More: U.K. Beats U.S. and Germany to Use of Vaccine They Created

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

The editors of the New England Journal of Medicine, which published the pivotal study of the vaccine Thursday, called the results a triumph that are impressive enough to hold up to any conceivable review.

“What appears to be a dramatic success for vaccination holds the promise of saving uncounted lives and giving us a pathway out of what has been a global disaster,” wrote Eric Rubin, editor-in-chief of the journal, and Dan Longo, the deputy editor.

(An earlier version of this story corrected the name of CDC official in third paragraph.)
–With assistance from Michelle Fay Cortez.

© 2020 Bloomberg L.P.

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