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article imageFDA to make it tougher to get a COVID-19 vaccine approved

By Karen Graham     Sep 22, 2020 in Health
The Food and Drug Administration (FDA) is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.
The reasoning behind this move by the FDA is not to purposely thwart President Donald Trump's efforts to have a coronavirus vaccine by election day, but rather, because American trust in the safety of a potential COVID-19 vaccine has plummeted with Trump's continued push to rush approval before "a very special date," according to the UK's Daily Mail.
Public trust has become the most important consideration when talking about the coronavirus pandemic this year. And the stakes are high. Added to the problem is the politicization of the pandemic and the vaccine by the Trump Administration. This has carried over to a massive loss of trust in our national health agencies
Trust in President Trump’s management of the COVID-19 crisis declined from 50 percent in late April to 43 percent in August, and this decline in trust in the government has carried over to the public's distrust of a coronavirus vaccine, according to a recent poll. A little less than 6 in 10 people surveyed (59 percent) said they would get a COVID-19 vaccination, a seven-point decline from late July (66 percent).
US President Donald Trump has said he expects a Covid-19 vaccine could be released before the Novemb...
US President Donald Trump has said he expects a Covid-19 vaccine could be released before the November 3, 2020 election, but experts are more cautious
MANDEL NGAN, AFP
The new requirements for an emergency use authorization
The Emergency use Authorization (EUA) the FDA is planning on announcing is far more stringent than the EUA used to get clearance for hydroxychloroquine or convalescent plasma. It is unlikely, that based on the status of the Phase 3 trials, that the vaccines will even be available before November, according to Market Watch.
Under the updated EUA rules, the FDA is expected to ask manufacturers seeking this authoriation to "follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot," according to two individuals familiar with the situation who spoke to the Washington Post on the condition of anonymity.
Additionally, to be assurred that the vaccine works, the FDA will be looking for at least five participants in the placebo group that developed severe COVID-19, as well as some cases of the disease in older people, meaning the trials will have to include older people.
FDA Commissioner Dr. Stephen Hahn, has not addressed the possibility of new vaccine approval standards. Hand-picked by Trump to oversee the FDA, the presumptive commissioner Ned Sharpless, was ignored. But Hahn has found himself caught between the political aspirations of the president and the science behind the coronavirus and production of a vaccine, and the need to be transparent with the public.
“It’s hard to imagine how an [emergency use authorization] could possibly occur before December,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines.
More about Covid19, Vaccine, Fda, tougher standards, Election day
 
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