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File Photo: FDA officials say they need the time to review the vaccine test data submitted by the company and make sure the conclusions are accurate (REUTERS)
File Photo: FDA officials say they need the time to review the vaccine test data submitted by the company and make sure the conclusions are accurate (REUTERS)
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Covid-19 vaccine approval process: Does it take too long?

Here are answers to some questions about the FDA review panels

The Food and Drug Administration will convene an independent panel of experts Feb. 26 to recommend whether the Johnson & Johnson Covid-19 vaccine should be authorized for use in the US.

The hearing comes 22 days after J&J submitted its application and supporting test data. That’s on par with the timetable the FDA set for review of the vaccine from Pfizer Inc. and partner BioNTech SE, but nearly a week longer than the one for the vaccine from Moderna Inc. Both were approved in December.

Some readers have questioned the amount of time needed to convene these review panels amid a global crisis and the urgent need to get vaccines distributed. Here’s a look at some of the issues involved:

How long does it take to review vaccine test data?

FDA officials say they need the time to review the vaccine test data submitted by the company and make sure the conclusions are accurate. As part of that review, FDA scientists scrutinize data from individual study volunteers, paying close attention to those who have had side effects and to differences between various demographic groups.

The time frame is still much shorter than the usual FDA review of proposed new drugs and vaccines, which normally takes months.

But the FDA took only about 2 ½ weeks to review the Moderna data. Why three weeks for J&J?

The circumstances have changed considerably since Dec. 17, when the FDA advisory committee recommended an emergency authorization for the Moderna vaccine about 2 ½ weeks after the company submitted data.

At that time, there weren’t any known significant variants to the coronavirus. And both the Moderna and Pfizer vaccine approved earlier were home runs—with effectiveness hovering around 95%—and showed strikingly similar results across the board, regardless of race, age, sex and medical history.

The agency will also have to spend several days analyzing the J&J shot’s effectiveness against variants identified in South Africa, the U.K. and elsewhere, and on varying effects in different groups of patients. The J&J data, in short, are nuanced.

“There is indeed a greater complexity here," said Peter Marks, director of the FDA biologics center.

What is this panel that will consider recommending approval of the J&J vaccine?

It is an independent committee of experts on vaccines, infectious diseases, pediatrics, epidemiology and other specialties that pertain. The committee advises the FDA on whether to authorize the use of the vaccine and in what groups of patients.

If the panel clears the vaccine for use, what happens next?

The FDA expects to act on the panel’s recommendations within a day after the hearing. If the FDA authorizes use of the vaccine, vaccinations could begin in a matter of days.

I’ve heard the J&J vaccine isn’t as effective as the others. Should I hold out for a Pfizer or Moderna vaccine?

Public health experts say no. To be sure, the Pfizer and Moderna vaccines reported stronger results. But in the world of vaccines, the J&J results—66% effective in its international study, and 72% effective in the U portion of the study—are considered good, and exceed the 50% standard the FDA set for vaccine efficacy.

The J&J shot showed efficacy of 57% even in South Africa where a resistant mutation of the coronavirus has spread.

And in preventing severe Covid illness—involving respiratory failure, shock, organ failure or death—the J&J shot was 85% effective. So in the very cases we’re most worried about, those involving hospitalization and death, the J&J vaccine was strikingly effective.

The J&J vaccine also has some significant advantages. It requires just one shot, not two as required for the Pfizer and Moderna vaccines. And it can be stored at regular refrigerator temperatures for longer periods than the Pfizer and Moderna vaccines. That can be helpful in rural areas especially.

New variants of the coronavirus appear to be popping up on a regular basis. How effective will the vaccines be in preventing them?

The pharmaceutical companies say the vaccines can be tweaked to address new strains of the virus, and the FDA has said it would work to streamline the approval process for these updated vaccines, much in the way it does now for flu shots.

Pfizer and Moderna have found, at least in the lab, that their vaccines appear to cover the variant identified in South Africa. Their vaccines also showed good effects against the mutation that arose in England.

If new evidence shows variants to be more resistant to the vaccines, both Moderna and the Pfizer partnership are designing new vaccines that more specifically target the variant strains.

How does this vaccine fit into the bigger picture, including overcoming public resistance to a vaccine?

Getting a third vaccine on the market could reduce hospitalization rates and the need for intensive care, which had placed US hospitals in a precarious situation.

Polls have shown many Americans—including significant numbers of healthcare workers—have been resistant to taking a vaccine. FDA officials say one reason they are vetting the results carefully is to ensure that the vaccine is safe and effective in all groups it is authorized for, so that any disappointing results don’t dampen people’s willingness to be vaccinated.

“That’s not what you want as a public health professional," said the FDA’s Dr. Marks.

This story has been published from a wire agency feed without modifications to the text.

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