Per a Wall Street report published on Friday, several drug companies making a vaccine for COVID-19 plan to issue a pledge to not look out for approval from the government until their respective vaccines are proven to be safe and effective.
The draft of the joint statement is still being finalized by J&J JNJ, Pfizer PFE, Moderna MRNA and others and may be issued as early as next week, the report said citing people familiar with the matter. The companies look to pledge to observe high ethical standards in conducting clinical studies and manufacturing of the vaccines, the report said.
Around a dozen companies are working on developing a vaccine for the deadly coronavirus disease, which has infected 27.2 million people globally and killed almost 0.9 million. Of these, COVID-19 vaccine candidates of AstraZeneca AZN/Oxford University, Moderna, Pfizer and its Germany-based partner, BioNTech are already in late-stage clinical studies. J&J is expected to initiate a pivotal phase III study this month.
The news comes amid rising pressure by the Trump administration to get a vaccine approved before the re-election in November. Trump’s prospects for re-election have been clouded by the coronavirus pandemic as he has been widely criticized for the way he handled the crisis. In such a scenario, if he can get a vaccine approved before the election, it can boost his chances of re-election.
Last month, the FDA granted emergency use authorization (EUA) to convalescent plasma, or blood from recovered COVID-19 patients, for the treatment of hospitalized COVID-19 patients. However, it is being speculated that the FDA rushed with the announcement of the EUA for plasma therapy under pressure from Trump as the latter had earlier in the month publicly expressed frustration at the slow pace of approval for coronavirus treatments/vaccines by the FDA for political reasons.
However, on Thursday, the White House Press Secretary Kayleigh McEnany said that there is no political pressure on U.S. regulatory agencies to quickly approve a vaccine.
Meanwhile, the FDA, in July, had issued guidance documents, specifying the data that the companies need to submit in order to get approval for their COVID-19 vaccines. Though the FDA is looking to expedite the development of a vaccine, it made it clear that it “will not cut corners” and sacrifice its standards for quality, safety, and efficacy while giving its decision for approval. If it approves a vaccine for EUA and it proves unsafe or ineffective, it could dent public confidence in the agency.
The joint safety pledge, if issued, should come as a bit of a relief over rising public concerns about pre-mature approval of a COVID-19 vaccine.
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