FDA Panel Endorses Pfizer’s Covid Shot

The disease is now “essentially out of control,” Kathrin Jansen, Pfizer’s PFE -0.29% head of vaccine research and development, told the Vaccines and Related Biological Products Advisory Committee. “Vaccine introduction is an urgent need.”

In its vote to approve, the panel said the benefits of the vaccine outweigh the risks for people 16 years of age and older.

“The efficacy is overwhelming” for the vaccine, said Eric Rubin, a Harvard microbiologist, panel member and editor-in-chief of the New England Journal of Medicine. “It’s very strong.”

“When you have 2,000 to 3,000 people a day—a day—dying of coronavirus, to me this was a clear choice,” said Ofer Levy, a panel member and director of the Precision Vaccines Program at Boston Children’s Hospital, after the vote.

Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine, said she dissented from the recommendation vote because there isn’t enough data justifying including 16 and 17 year olds in an emergency authorization.

“They’re not a high-risk group,” she said in an interview. “My concern was that the data was very limited in the 16,17 year olds.” She said she would have voted in favor otherwise, saying that for adults the benefits of the vaccine outweigh the risks.

Oveta Fuller, a virologist at the University of Michigan Medical School, also dissented, saying in an interview that she would like to see at least two more months of data on trial participants that could help determine whether the vaccine reduces transmission.

That advisory committee’s decision paves the way for the FDA to green-light distribution of the vaccine. That step is expected as early as Friday or this weekend, given the magnitude of the public-health crisis and scientific analysis that showed the vaccine is safe and 95% effective in combating Covid-19 among test subjects.

While the outside doctors—mostly infectious-disease physicians, pediatricians and vaccine specialists—overwhelmingly supported granting the emergency-use authorization, panelists raised some concerns over side effects and reactions.

At least two of the patients who received the vaccine this week in England had allergic reactions after getting the vaccine. Various panel members called on the FDA and Pfizer PFE -0.29% to do further study of the issue.

“This issue is not going to die until we have better data” about the extent and nature of the reactions, said panelist Paul Offit, a vaccine expert and pediatrics professor at the Children’s Hospital of Philadelphia.

Dr. Jansen said Pfizer was studying whether the vaccine protects against asymptomatic Covid-19 and hopes to complete that analysis early next year.

Pfizer also said during the presentation Thursday it plans to file for full approval, through what is known as a biologics license application, by April 2021.

The Food and Drug Administration and other federal agencies will monitor the use of Covid-19 vaccines long after their release, including the question of how long vaccines will confer immunity, federal officials said at an FDA vaccine panel meeting Thursday.

Nancy Messonnier, a senior official at the U.S. Centers for Disease Control and Prevention specializing in vaccines, said her agency, along with the FDA and the Department of Defense, will conduct “active surveillance” of health-care workers and residents of long-term-care facilities getting shots to gauge the effects of the immunization.

“We really need people to sign on to this system to provide us with the best data possible,” she said.

Dr. Messonnier said that such longer-term study will focus on whether children under 16 can benefit from this or other vaccines. So far, the FDA has said, there isn’t enough evidence to prove that a vaccine has a benefit for children. Answering that question could be crucial for reopening most school systems safely.

The vaccine has already been shown in clinical research to reduce the rate of symptomatic disease by 95%, and appears headed for FDA approval. The FDA isn’t required to accept the decision of an advisory panel, but generally does so.

Doran Fink, deputy clinical director of the FDA’s division of vaccines, said further evaluation of the vaccine after its release will be necessary to see if its benefits continue to outweigh its risk, and whether any labeling changes will be required.

Dr. Fink also addressed one major topic that has been in question—whether patients in the Pfizer trial who were randomly assigned to placebo should automatically be switched over and get the vaccine. FDA staffers told the committee they shouldn’t.

On behalf of the FDA, he recommended “continuation of blinded, placebo-controlled follow-up in ongoing clinical trials for as long as is feasible.”

Pfizer said it would make the vaccine available to placebo-group subjects as long as they meet the requirements of potential FDA terms and any CDC recommendations for prioritization, according to Bill Gruber, senior vice president of Pfizer’s vaccine clinical research.

The subjects can be in so-called blinded status through the end of the trial should they choose, meaning that they wouldn’t know whether they had received vaccine or placebo at different times during the study.

Steven Goodman, a Stanford University School of Medicine dean and epidemiologist, described that choice in testimony before the panel as an “ethical dilemma” in which both answers—getting vaccines to placebo patients and developing long-term safety and effectiveness—are right, and neither is unethical. In evaluating the question, Dr. Goodman suggested to the committee “not to use that word at all.”

Marion Gruber, director of the FDA’s office of vaccines (and no relation to Bill Gruber), said she is concerned that if there is an unblinding of patients, that might limit the ability of the study to gather enough data about the vaccine’s safety.

In answer to questions from the committee, Dr. Fink said the FDA will insist on six months’ follow-up data about safety and side effects when it considers any vaccine for a full approval. The current evaluation by the FDA involves two months of safety data for an FDA clearance—short of a full approval—called an emergency use authorization.

The results described in company and FDA analyses earlier this week showed the vaccine’s effectiveness hovered around 95% in all ages and ethnic groups. Those data are especially important, since members of some ethnic groups have shown hesitancy about getting a vaccine.

The findings regarding vaccine effectiveness were also consistent among patients with underlying conditions such as obesity, diabetes, high blood pressure and chronic cardiopulmonary disease.

Serious side effects were extremely rare, though two patients in the U.K. who got the first doses this week had allergic reactions, which were quickly treated. British authorities cleared the vaccine for use last week, as did Canada on Wednesday.

Pfizer officials said during Thursday’s presentation that there were no serious allergic reactions to the vaccine reported by trial subjects. The FDA said it was continuing to collect information about the U.K. information

The FDA said patients who got the vaccine during a company clinical study commonly had reactions such as injection-site irritation, fatigue, headache, muscle pain, chills, joint pain and fever. The agency and companies reported on safety data for about 19,000 vaccinated patients in the companies’ research, which included a total of 43,448 patients ages 16 and up.

The committee members, largely composed of doctors such as immunologists, vaccine experts, statisticians and infectious-disease physicians, are expected to focus on side effects as well as data by age, sex and ethnic group.

In the study, a confirmed Covid-19 case was defined as a positive diagnostic test, plus one or more symptoms, such as a new or increased cough or shortness of breath, loss of taste or smell, sore throat, diarrhea and vomiting.

Write to Thomas M. Burton at [email protected] and Jared S. Hopkins at [email protected]

Corrections & Amplifications
A Food and Drug Administration advisory panel endorsed Pfizer-BioNTech’s Covid-19 vaccine. The headline on an earlier version of this article incorrectly said the panel had approved the vaccine. The panel doesn’t have that authority.