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Moderna reached human testing for its COVID-19 vaccine candidate in record time and now, with its Phase 3 trial moving forward, the company expects efficacy data in November, likely after Pfizer and BioNTech, but earlier than all. the rest.
Biotech thinks it will know in November if the vaccine works, Chief Executive Stéphane Bancel said on CNBC on Thursday. A reading in October is possible but unlikely, he added, while a reading in December would represent the “worst case scenario.”
As the pandemic gained traction earlier this year, researchers at Moderna and the NIH quickly moved into phase 1 testing in March. After the success of that test, the company began its phase 3 test in July. The study researchers have already enrolled about 25,000 people and 10,000 people have received the second dose of the vaccine or placebo.
But Moderna is not the only company expecting results this year. Pfizer CEO Albert Bourla has said his company expects to know if the vaccine works by the end of October.
AstraZeneca, the other company in a phase 3 study in the US, had to pause its late-stage trial due to a safety scare, but its partner, the University of Oxford, concluded that it was “unlikely” that the disease was related to the vaccine. AstraZeneca is on track to submit its data by the end of the year, CEO Pascal Soriot told the Financial Times after the delay.
As the vaccines progress, the FDA has set up an advisory committee meeting on October 22 to discuss progress.
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Also on Thursday, Moderna released the test protocol for the high-profile phase 3 study. With that and the public results to date, Jefferies analysts wrote to clients that “the probability of success is high for a positive reading in the fourth quarter.”
All vaccines advance as questions arise about the political pressure affecting FDA’s decision-making process. President Donald Trump has said a vaccine could arrive “in a matter of weeks,” echoing previous comments that he is pushing for a vaccine to be available before the November 3 election.
Previous FDA decisions during the pandemic have not allayed concerns that policy will influence the scientific process. When the agency issued its emergency use authorization for convalescent plasma last month, FDA Commissioner Stephen Hahn made misleading comments about the treatment that he later acknowledged were incorrect.
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Before that, the agency issued an EUA for hydroxychloroquine, an antimalarial drug that President Trump had been promoting as a COVID treatment, but later revoked the authorization when controlled trials showed no benefit for the drug.
In response to the controversies, major vaccine players have pledged not to rush to market, and top FDA officials have pledged to follow the science as the agency makes key decisions during the pandemic.
