Northwest Arkansas Democrat-Gazette
FDA advisory panel backs vaccine
Agency nod awaited to ship doses to states
WASHINGTON — Federal advisers endorsed the Pfizer-BioNTech coronavirus vaccine on Thursday, making it likely the Food and Drug Administration will authorize the vaccine on an emergency basis within hours or days, kicking off an effort to inoculate enough Americans to stop a rampaging pandemic.
The thumbs-up from the FDA’s vaccine advisory committee was the culmination of an all-day meeting during which the panel heard presentations on the safety and effectiveness of the vaccine, including plans to monitor its longer-term safety.
The key moment came at the end of the meeting when the agency asked its independent advisers: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech covid-19 vaccine outweigh its risks for use in individuals 16 years of age and older?”
In a 17-4 vote, with one abstention, the committee voted yes.
If as expected the FDA follows quickly with an emergency authorization, the shots will start being moved to the states within 24 hours, according to officials at Operation Warp Speed, the Trump administration’s effort to accelerate the development and delivery of vaccines. Inoculations could begin early next week, officials say.
FDA Commissioner Stephen Hahn confirmed Thursday in an interview on NBC’s “Today” show that the agency intended “to act quickly” if the committee issued a favorable recommendation.
After the FDA authorization, an advisory committee
to the Centers for Disease Control and Prevention will vote on whether to recommend the vaccine and for whom. First in line to be inoculated are health care personnel and residents and staff of long-term care facilities, according to previous recommendations from the CDC panel. But states will have the final say on who gets the first shots and where they are administered. Those considerations are complicated by extreme logistics challenges, including the sub-Antarctic storage temperatures the vaccine requires.
During the meeting Thursday, committee members pressed the FDA on the safety of the vaccine, including raising questions about the allergic reactions that cropped up Wednesday when British regulators ordered hospitals to not give the shots to people who have a history of “significant” allergic reactions. That directive came after two health care workers had adverse reactions after receiving the first dose of the vaccine, which British regulators authorized last week. British authorities said both workers have a history of serious allergies.
In its review of the Pfizer vaccine, the FDA found a slightly higher number of adverse events — “potentially representing allergic reactions” — in the group that received the vaccine, compared with those who got the placebo. There were 137 “hypersensitivity-related” reactions to the vaccine, compared with 111 such events in the placebo group.
Susan Wollersheim, a medical officer in the FDA’s Office of Vaccines Research and Review, said the FDA has asked Pfizer to monitor vaccine recipients for “anaphylactic reactions” as a potential risk after the British reports.
But much remains unknown about the cases in the United Kingdom, and experts said more data was urgently needed. A specific study could be done to see if the vaccine carried risk to people with severe allergies.
“There are tens of millions of people in this country that carry EpiPens because they have peanut allergies and egg allergies. They are going to believe that they can’t get this vaccine. That is a lot of people,” said Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia and a member of the advisory committee.
ADVISORY ON PREGNANCY
Vaccination programs from Russia to the United Kingdom are excluding women who are pregnant, breastfeeding or planning for a pregnancy as the vaccine candidates were not clinically tested on these populations as part of their initial trials.
“Evidence so far reviewed … raises no concerns for safety in pregnancy,” Public Health England explained on its website. But “because of the new formulation of this particular vaccine … [it] wants to see more nonclinical data before finalising the advice in pregnancy.”
The advisory continued, “It is standard practice when waiting for such data on any medicine, to avoid its use in those who may become pregnant or who are breastfeeding. This will be kept under review as more evidence becomes available.”
Russia’s recent initial rollout of its Sputnik vaccine similarly did not include this demographic.
Pregnant women have been excluded from coronavirus vaccine trials, but the FDA’s limited data doesn’t suggest a specific risk to pregnant women or a fetus. Doran Fink, deputy director of the FDA’s Division of Vaccines and Related Products Applications, said the agency is expecting later this month a developmental and reproductive toxicity study in animals that could help elucidate any risks, but will likely allow pregnant women and their doctors to decide whether to take the vaccine.
An authorization for Pfizer-BioNTech is the first of what health experts hope will be several vaccines to cross the finish line. Next to be considered is Moderna’s vaccine. The FDA will release its assessment of that vaccine Tuesday. If it gets favorable evaluations, as expected, the FDA is likely to authorize that vaccine within days. Between the two vaccines, government officials project having 40 million doses by the end of the year — enough to fully vaccinate 20 million people with the two-shot regimen.
Canada’s health regulator on Wednesday approved Pfizer’s coronavirus vaccine. Canadian officials expect to administer them within days. Britain began vaccinations on Tuesday, after authorizing the shots last week. While some have wondered whether the FDA could have acted more quickly, Doran Fink, deputy director in FDA’s Division of Vaccines and Related Products Applications said that the agency has been working nonstop to review the companies’ data.
“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” Fink said. “That is what FDA physicians and scientists, all of us career public health servants, have been doing over days, nights, weekends and, yes, over the Thanksgiving holiday. This is in addition to months of review work already completed.”
There was extensive debate over how to handle the issue of when to give participants who received the placebo access to the vaccine. Some participants have called for it, but the FDA has expressed concerns that “unblinding” could hurt efforts to collect longer-term safety data.
Pfizer officials on Thursday proposed to the FDA that participants in the placebo group be eligible to receive the vaccine when they become eligible due to age or other risk factors if they were not in the trial. Eligibility would be determined by local and national guidelines.
In preparation for the meeting, the FDA on Tuesday published a 53-page evaluation saying the vaccine appears to meet the standards it laid out in recent months for emergency authorization. The agency has said a vaccine must be at least 50% effective; its own scientists confirmed Pfizer’s assessment that the vaccine regimen was 95% effective at preventing covid-19 in a large clinical trial.
On safety, the FDA found that the vaccine has “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].” The vaccine caused several side effects, including sore arms, fatigue, headaches, muscle pain and chills, but they typically disappeared after a day or two. Pfizer provided the agency with a median of two months of follow-up on 38,000 participants in the trial.
TOLL NEARS 300,000
Just as the U.S. appears on the verge of rolling out a covid-19 vaccine, the numbers have become gloomier than ever: Over 3,000 American deaths in a single day, more than on D-Day or 9/11. One million new cases in the span of five days. More than 106,000 people in the hospital.
The crisis across the country is pushing medical centers to the breaking point and leaving staff members and public health officials burned out and plagued by tears and nightmares.
All told, the crisis has left more than 290,000 people dead nationwide, with more than 15.5 million confirmed infections.
The U.S. recorded 3,124 deaths Wednesday, the highest one-day total yet, according to Johns Hopkins University. Up until last week, the peak was 2,603 deaths on April 15, when New York City was the epicenter of the nation’s outbreak. The latest number is subject to revision up or down.
Wednesday’s toll eclipsed American deaths on the opening day of the Normandy invasion during World War II: 2,500, out of some 4,400 Allied dead. And it topped the toll on Sept. 11, 2001: 2,977.
New cases per day are running at all-time highs of over 209,000 on average. And the number of people in the hospital with covid-19 is setting records nearly every day.
U.S. health experts are hoping a combination of vaccines will ultimately enable the U.S. to conquer the outbreak.
But experts estimate at least 70% of the U.S. population will have to be vaccinated to achieve herd immunity, the point at which the virus can be held in check. That means it could be several months before things start getting back to normal and Americans can put away their masks.