Drugmakers Expected To Pledge COVID Vaccine Safety In Effort To Diminish Fears

Neal Browning receives a shot in the first-stage safety study clinical trial of a potential vaccine for the COVID-19 coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Browning is the second patient to receive the shot in the study. (AP Photo/Ted S. Warren)
FILE - In this March 16, 2020, file photo, a subject receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19, the disease caused by the new coronavirus, at the Ka... FILE - In this March 16, 2020, file photo, a subject receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle. According to results released on Tuesday, July 14, 2020, early-stage testing showed the first COVID-19 vaccine tested in the U.S. revved up people’s immune systems the way scientists had hoped. The vaccine is made by the National Institutes of Health and Moderna Inc. (AP Photo/Ted S. Warren, File) MORE LESS
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September 5, 2020 2:47 p.m.
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A group of drug companies racing against each other to develop coronavirus vaccines, are planning to release a statement early next week pledging that they will not prematurely release a vaccine amid political pressure to deliver on a presidential election timeline that is now just two months away.

A copy of the companies’ draft statement obtained by the Wall Street Journal says the drugmakers will submit applications for government emergency-use authorization or vaccine licensing based on “substantial evidence of safety and efficacy” from advanced clinical trials conducted under Food and Drug Administration guidance.

The announcement of the pledge comes as concerns mount that a COVID-19 vaccine is being jammed through federal regulation to deliver a Trump campaign victory ahead of the election.

The companies have said they will look at Phase 3 trials, which are designed to demonstrate the efficacy of the shots at reducing rates of symptomatic COVID-19 compared with unvaccinated people.

The manufacturers who have reportedly signed the letter include Pfizer, Moderna, Johnson & Johnson, GlaxoSmithKline and Sanofi. 

The news comes as doubts swell regarding the safety and efficacy of a vaccine that has faced a sped up timeline. Vaccine development usually takes years, yet Covid-19 shots are progressing at a rapid pace as companies and countries rush to stop the spread of the coronavirus. 

Several of the companies have already embarked on large clinical trials that include at least 30,000 people. There was some discussion in recent weeks about possible emergency-use authorization or approval.

Last week, the CDC told state officials that they should prepare to launch COVID-19 vaccination campaigns by November. 

The timeline coincides within days of the presidential elections on Nov. 3.  Last month, President Donald Trump tweeted a conspiracy meant to pressure and simultaneously undermine the FDA by suggesting that a “deep state” within the agency was intentionally delaying trials for a vaccine to deny him a victory that would likely boost his chances ahead of the election.

Those remarks have intensified concern by lawmakers, with some states even refusing to distribute a vaccine if it is not properly vetted or that appears to cling too closely to Trump’s political schedule

While the federal government has pledged to deliver 300 million doses by January 2021, the FDA has said it won’t approve a shot for coronavirus unless there is evidence showing it is 50% effective compared with a placebo.

But the credibility of the FDA is in repair, after it recently hastily authorized  convalescent plasma to treat Covid-19 patients.

Earlier this summer, the FDA was also forced to revoke the emergency-use authorization of hydroxychloroquine, an antimalarial touted by Trump following concerns about its safety and efficacy as treatment.

FDA commissioner Stephen Hahn was on the receiving end of Trump’s earlier attack on the vaccine’s slower pace when he offered the glowing review of the treatment — he later apologized for presenting an overzealous picture that raved of the treatment’s effectiveness. 

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