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Oct. 6, 2020, 1:21 p.m. EDT

FDA to require 2-month follow-up period for COVID-19 vaccines before authorization

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By Jaimy Lee

Pharmaceutical companies developing COVID-19 vaccines should wait two months after late-stage studies conclude to submit an application for an emergency use authorization to the Food and Drug Administration, the regulator said Tuesday. In a guidance document released in advance of a planned Oct. 22 meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA said an application should include "data from Phase 3 studies that includes a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile." It is also asking drug makers to wait until there are at least five cases of severe COVID-19 reported among the group of people who received the placebo. The New York Times this week had reported that the Trump administration is trying to block the two-month review in order to speed up the authorization and distribution of coronavirus vaccines. A separate report in Politico this week said that White House officials had told Trump that the drug industry is resistant to the guidelines. There are four COVID-19 vaccine candidates in late-stage clinical trials in the U.S., developed by AstraZeneca /zigman2/quotes/200304487/composite AZN +0.15% /zigman2/quotes/203048482/delayed UK:AZN +0.93% and the University of Oxford, BioNTech /zigman2/quotes/214419716/composite BNTX -2.16% and Pfizer Inc. /zigman2/quotes/202877789/composite PFE -0.55% , Johnson & Johnson /zigman2/quotes/201724570/composite JNJ -2.02% , and Moderna Inc. /zigman2/quotes/205619834/composite MRNA +0.82% . None of these companies have released Phase 2 or Phase 3 clinical data at this time. Pfizer CEO Albert Bourla on Tuesday tweeted that "Pfizer has never discussed [the FDA's COVID-19] vaccine guidelines with the White House and will never do so as it could undermine the agency's independence."

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US : U.S.: Nasdaq
$ 47.23
+0.07 +0.15%
Volume: 16.00M
March 4, 2021 4:00p
P/E Ratio
38.53
Dividend Yield
2.90%
Market Cap
$124.64 billion
Rev. per Employee
$352,484
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/zigman2/quotes/203048482/delayed
UK : U.K.: London
6,857.00 p
+63.00 +0.93%
Volume: 3.00M
March 4, 2021 4:35p
P/E Ratio
36.19
Dividend Yield
3.02%
Market Cap
£89.19 billion
Rev. per Employee
£272,751
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/zigman2/quotes/214419716/composite
US : U.S.: Nasdaq
$ 95.15
-2.10 -2.16%
Volume: 2.34M
March 4, 2021 4:00p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$23.42 billion
Rev. per Employee
$92,777
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/zigman2/quotes/202877789/composite
US : U.S.: NYSE
$ 34.20
-0.19 -0.55%
Volume: 45.45M
March 4, 2021 4:02p
P/E Ratio
20.00
Dividend Yield
4.56%
Market Cap
$191.81 billion
Rev. per Employee
$533,860
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/zigman2/quotes/201724570/composite
US : U.S.: NYSE
$ 153.07
-3.15 -2.02%
Volume: 11.03M
March 4, 2021 4:00p
P/E Ratio
27.77
Dividend Yield
2.64%
Market Cap
$410.65 billion
Rev. per Employee
$613,918
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/zigman2/quotes/205619834/composite
US : U.S.: Nasdaq
$ 132.30
+1.08 +0.82%
Volume: 10.93M
March 4, 2021 4:00p
P/E Ratio
N/A
Dividend Yield
N/A
Market Cap
$52.46 billion
Rev. per Employee
$617,996
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