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U.S. FDA to tighten coronavirus vaccine authorization standards ahead of election - paper

Published 09/22/2020, 04:18 PM
Updated 09/22/2020, 06:20 PM
© Reuters. FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration

© Reuters. FILE PHOTO: Small bottles labeled with a "Vaccine COVID-19" sticker and a medical syringe are seen in this illustration

(Reuters) - The U.S. Food and Drug Administration is expected to soon announce new, more stringent standards for an emergency authorization of a COVID-19 vaccine, lowering the chances that one might be cleared for use before the Nov. 3 election, the Washington Post reported on Tuesday.

The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process, the newspaper said.

According to the report, the FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of severe cases of COVID-19 in patients who received a placebo in the trials.

Few vaccine developers were expected to have definitive trial results before the presidential election. Pfizer Inc (NYSE:PFE) had been the exception, although its timetable could slip with the new guidance.

Moderna (NASDAQ:MRNA) Inc has said it is unlikely to have data in October. AstraZeneca (NYSE:AZN) Plc's trial in the United States is halted while investigators try to determine whether a serious neurological problem suffered by one participant in the company's U.K. trial was caused by the vaccine.

Moderna and Pfizer began their late-stage trials on July 27, and took about a month to enroll 15,000 people, the halfway point for their initial planned enrollment.

The trials are designed for people to receive their second shot either three or four weeks after the first. Two months of follow-up would make it unlikely the companies would have enough data before mid-November.

Pfizer said on Tuesday that based on current infection rates it still expects to know whether or not their vaccine works as early as the end of October. Pfizer's trial protocol calls for an early look at the data after just 32 participants become infected.

© Reuters. FILE PHOTO: Small bottles labeled with a

"We anticipate providing FDA with safety data, including the median of two months safety data after the second dose, on a rolling basis to help inform FDA’s ultimate determination of authorization or approval," the drugmaker said in an emailed statement.

Latest comments

So, the FDA caves to liberal lobbying, or perhaps the FDA has a liberal agenda. Either way, it is VERY disappointing that they are, all of a sudden, making the rules for the development of the COVID virus vaccine more stringent. It wasn't that long ago that the FDA was preaching how important it is to develop a COVID vaccine and that they would loosen their obnoxiously expensive and politically motivated rules so that a vaccine could be developed quickly and still be safe for the population. Now, suddenly they are reversing their stance. The FDA is an agency that needs to exist, for safety reasons. However, it could cost upwards of $USD 500 million- $USD 1 billion and years of testing to bring a drug to market. Thereby guaranteeing ridiculously expensive drug prices. The process does NOT need to be that expensive and a large portion of drugs that are developed cannot be afforded by the average person(s) nor will insurance companies cover their costs.
Vaccinating is the introduction into the body of a diluted sickness to enhance body's de fense. However if such an action fails it may ****the body. And there are thousands reasons for failing, this is why it has to be tested on long run: the virus is not listening to any human request and development remains independent from any political, economical or financial timing. In some ways this is somehow similar to pregnancy: usuallyhuman development takes 9 months. It happens, in some circumstances, but then death(s) increase EXPONENTIALLY.  Nowadays no one impedes you to take the risk for yourself, as wearing masks, distancing, etc. but, as for AIDS, if you are aware being a victim, you should protect your partner. Otherwise is CRIMINAL. Same forthe COVID: if you are aware of a very slightrisk - providing the vaccine even -  to million people you may be a mass criminal. If this was ignored, now you are all aware of it-
Perfect explanation, thank you
I stopped after the first sentence because that is not even close to how the Moderna vaccine works. I didn’t bother to read the rest because it appears you have no clue what you’re talking about.
Next thing the FDA will ask the vaccine to also help people lose weight for at least a year before authorization.
The greates country in the world and it’s unable to create a vaccine. Do not let politics stop you from saving people’s life. More than 200 000 death. just make it happen and stop the BS.
Amd u know politics are the reason, why?
creating one is easy, making sure its safe is not, you cant rush something that ensure safety
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