A group of drug companies racing against one another to develop coronavirus vaccines, are planning to launch a statement early next week pledging that they won't prematurely launch a vaccine amid political pressure to deliver on a presidential election deadline that's now just two weeks away.
A replica of those companies' draft statement obtained by the Wall Street Journal claims that the drugmakers will submit applications for authorities emergency-use authorization or vaccine licensing based on"substantial evidence of efficacy and safety" from advanced clinical trials conducted under Food and Drug Administration guidance.
The statement of this pledge comes as worries mount a COVID-19 vaccine has been jammed through national law to deliver a Trump campaign success before the election.
The companies have said they'll look at Phase 3 trials, which are intended to demonstrate the effectiveness of their shots at reducing rates of symptomatic COVID-19 compared with unvaccinated folks.
The producers who have signed the letter include Pfizer, Moderna, Johnson & Johnson, GlaxoSmithKline and Sanofi.
The news is as doubts swell concerning the efficacy and safety of a vaccine which has confronted a sped up timeline. Vaccine development usually takes decades, yet Covid-19 shots are progressing at a fast pace as companies and nations rush to block the spread of the coronavirus.
A number of the companies have already embarked on large clinical trials which include at least 30,000 people. There was some debate in recent weeks about potential emergency-use approval or authorization.
Last week, the CDC told state officials that they ought to prepare to establish COVID-19 vaccination campaigns by November.
The deadline coincides within days of the presidential elections on Nov. 3. Last month, President Donald Trump tweeted a conspiracy intended to pressure and simultaneously undermine the FDA by indicating that a"deep state" inside the bureau was apprehended trials for a vaccine to deny him a success that would probably boost his chances before the election.
Those opinions have intensified concern by lawmakers, with some countries even refusing to distribute a vaccine if it's not properly assessed or that seems to cling too closely to Trump's political program.
While the federal government has vowed to deliver 300 million doses by January 2021, the FDA has stated it will not approve a shot for coronavirus unless there's evidence showing it's 50% effective compared with a placebo.
However, the credibility of the FDA is in fix, after it recently authorized convalescent plasma to treat Covid-19 patients.
Earlier this summer, the FDA was also made to reverse the emergency-use authorization of hydroxychloroquine, an antimalarial touted by Trump following concerns regarding its efficacy and safety as treatment.
FDA commissioner Stephen Hahn was on the receiving end of Trump's earlier assault on the vaccine's slower rate when he provided the glowing review of the treatment -- he later apologized for presenting an overzealous image that raved of this treatment's effectiveness.
A replica of those companies' draft statement obtained by the Wall Street Journal claims that the drugmakers will submit applications for authorities emergency-use authorization or vaccine licensing based on"substantial evidence of efficacy and safety" from advanced clinical trials conducted under Food and Drug Administration guidance.
The statement of this pledge comes as worries mount a COVID-19 vaccine has been jammed through national law to deliver a Trump campaign success before the election.
The companies have said they'll look at Phase 3 trials, which are intended to demonstrate the effectiveness of their shots at reducing rates of symptomatic COVID-19 compared with unvaccinated folks.
The producers who have signed the letter include Pfizer, Moderna, Johnson & Johnson, GlaxoSmithKline and Sanofi.
The news is as doubts swell concerning the efficacy and safety of a vaccine which has confronted a sped up timeline. Vaccine development usually takes decades, yet Covid-19 shots are progressing at a fast pace as companies and nations rush to block the spread of the coronavirus.
A number of the companies have already embarked on large clinical trials which include at least 30,000 people. There was some debate in recent weeks about potential emergency-use approval or authorization.
Last week, the CDC told state officials that they ought to prepare to establish COVID-19 vaccination campaigns by November.
The deadline coincides within days of the presidential elections on Nov. 3. Last month, President Donald Trump tweeted a conspiracy intended to pressure and simultaneously undermine the FDA by indicating that a"deep state" inside the bureau was apprehended trials for a vaccine to deny him a success that would probably boost his chances before the election.
Those opinions have intensified concern by lawmakers, with some countries even refusing to distribute a vaccine if it's not properly assessed or that seems to cling too closely to Trump's political program.
While the federal government has vowed to deliver 300 million doses by January 2021, the FDA has stated it will not approve a shot for coronavirus unless there's evidence showing it's 50% effective compared with a placebo.
However, the credibility of the FDA is in fix, after it recently authorized convalescent plasma to treat Covid-19 patients.
Earlier this summer, the FDA was also made to reverse the emergency-use authorization of hydroxychloroquine, an antimalarial touted by Trump following concerns regarding its efficacy and safety as treatment.
FDA commissioner Stephen Hahn was on the receiving end of Trump's earlier assault on the vaccine's slower rate when he provided the glowing review of the treatment -- he later apologized for presenting an overzealous image that raved of this treatment's effectiveness.