Moderna expects coronavirus vaccine results in November

Russia to Send India 100M Coronavirus Vaccine Doses

Russian Federation was the first country to authorize a COVID-19 vaccine, but it did so before completing proper scientific studies to show it is safe and effective.

"If what we end up with is people in poor countries getting untested vaccines, first of all, ethically, that's a disaster", said Dr. Ashish Jha, the dean of Brown University's School of Public Health.

But molecular biologist Dr. Enrico Bucci said he quickly developed "several concerns" upon looking at the data.

President Donald Trump, who is seeking re-election, has said a vaccine to fight the coronavirus pandemic is possible before the November 3 US vote, raising concerns over political interference. Scientists have questioned whether drugmakers will have enough evidence to achieve success by that time.

India is also independently assessing two home-grown vaccines, now in phase 2 trials, and an Oxford-made vaccine in phase 3 trials.

A company's protocol is submitted to the FDA for review and is overseen by an independent panel of experts known as a Data and Safety Monitoring Board. Those who receive these vaccines will need to receive doses made by the same drugmaker. "The Phase I and II clinical trials have shown promising results".

If the drugmaker's vaccine does not meet the 76.9% efficacy target at this first interim analysis, it would face tougher statistical significance thresholds during subsequent interim assessments, biostatisticians who reviewed the protocol said.

Russia to Send India 100M Coronavirus Vaccine Doses
Russia confirms deal with Dr. Reddy's for COVID-19 vaccine 'Sputnik V' trials in India, to supply 100 million doses

As calculated by Oxfam, the combined production capacity of the five vaccine candidates is 5.94 billion doses, which is only enough for 2.97 billion people given that all five future vaccines will or are highly likely to require two doses.

The decision by Moderna, which has received $2.5 billion in USA government money, left a spotlight on Pfizer, whose CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump's wishes.

Some vaccine experts have said drugmakers should wait to reach their final analyses of more than 150 cases before seeking FDA approval. But the company enjoys the confidence and backing of the United States government which has pumped in more than a billion dollars to help the company accelerate the vaccine development, and pre-booked hundreds of millions of doses, when it becomes available.

Company CEO Stephane Bancel has said if the vaccine candidate was found to be at least 50 per cent effective, the minimum bar set by the US Food and Drug Administration for approving a vaccine, it would immediately move to apply for an emergency use authorisation.

Eric Topol, the editor-in-chief of Medscape and a professor of molecular medicine at The Scripps Research Institute, wrote in an email that "aggressive" would be "too kind" of a way to describe the trial design, which "has the optics of wanting (engineering) the trial to stop early which is not good". "And if you don't know how effective it is, you don't know what to tell people, and you're going to create this huge false sense of confidence that could be very, very unsafe".

"Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India", RDIF added. Its U.S. trial is now on hold after a patient fell ill.


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