MRNA Moderna Inc

By Thomas M. Burton and Joseph Walker 

The Food and Drug Administration is days away from beginning its evaluation of Covid-19 vaccines for emergency use -- a process that could lead to vaccine distributions by year's end to limited groups such as health-care workers and the elderly.

Pfizer Inc. and German partner BioNTech SE plan to submit their vaccine testing data to the FDA within days, followed closely by Moderna Inc. That will set off a process in which FDA scientists will begin to assess the accuracy of company data, which is likely to take two to three weeks.

As part of that review, FDA scientists are expected to look at data from individual patients, such as for indications of any troubling side effects.

After the FDA staff review, an independent panel of doctors from major U.S. academic centers will meet to advise the FDA on the vaccines' efficacy -- likely in early December.

The advisory panel will consider questions such as whether the vaccine has been shown safe and effective in certain racial, ethnic and age groups. The panel will likely be asked to recommend whether the vaccine should be authorized for use and in which populations.

Pfizer, which said Wednesday it is on the verge of seeking FDA review, has reported that its vaccine is more than 94% effective in adults over 65. It said that about 42% of its trial participants represent racial or ethnic minority groups.

After the review, the FDA then will decide whether to grant an "emergency use authorization," a quicker version of the normal FDA approval.

At the center of the process is Dr. Peter Marks, 57 years old, who oversees vaccines as the director of the FDA's Center for Biologics Evaluation and Research. Trained at New York University and Boston's Brigham and Women's Hospital, he led the Adult Leukemia Service at Yale University before joining the FDA in 2012.

If the FDA authorizes a vaccine, it "could in theory start rolling off the assembly line into the arms of the American public by the end of December," said Paul Offit, a vaccine expert from the Children's Hospital of Philadelphia who is on the FDA's advisory vaccine panel.

Even after the FDA authorizes a vaccine, it will be several months before the general public is able to get vaccinated at their local pharmacies. The U.S. government has contracted to purchase at least 100 million doses each of the Pfizer and Moderna vaccines, but most of the doses won't be ready until next year.

Because of the supply constraints, the government will give priority to certain groups, likely health-care workers and the elderly, to be vaccinated first.

Initially, people will be vaccinated at hospitals and large medical centers because supplies will be limited, said Marion Whicker, deputy chief of supply, production and distribution at Operation Warp Speed, the federal initiative to speed development of Covid-19 drugs and vaccines.

"When you see vaccines start to equal or exceed demand is when you'll see it out of the pharmacies," said Ms. Whicker.

Moderna said this week it would have 20 million vaccines doses ready to ship in the U.S. by the end of the year, enough to treat 10 million people. Pfizer and BioNTech said they expect to manufacture up to 50 million doses globally this year, with about half of the doses going to the U.S. -- or enough to vaccinate 12.5 million Americans with the two-shot regimen.

Immediately after the FDA authorization, an advisory committee convened by the Centers for Disease Control and Prevention will hold a public hearing to review the vaccine data and recommend which groups to give priority to for inoculation. The CDC will take the committee's recommendation into account before deciding which groups to give priority to.

The government will allocate the vaccines to states proportionally based on population, Alex Azar, secretary of the Department of Health and Human Services, said on a conference call with reporters on Wednesday.

State groups have pressed Congress and HHS for billions more in funding to help with the distribution effort.

Stephanie Armour contributed to this article.

Write to Thomas M. Burton at tom.burton@wsj.com and Joseph Walker at joseph.walker@wsj.com

(END) Dow Jones Newswires

November 19, 2020 08:46 ET (13:46 GMT)

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