Trials of Russian COVID-19 Vaccine Start in Venezuela, President Maduro Says

Grant Boone
October 16, 2020

But before any drugmaker can apply for emergency use authorization of a Covid-19 vaccine candidate, the Food and Drug Administration will require two months of safety information following the final dose of vaccine.

Despite President Trump's repeated promises of a vaccine before election day, scientists have been cautioning that it's unlikely that data showing a shot actually works would come until November or December.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

They aim to deliver tens of millions of doses in the U.S. by the end of the year.

Chinese authorities have to date not released pricing details for potential Covid-19 vaccines.

Bourla said data on the vaccine's effectiveness may come earlier or later based on whether the late-stage trial of the vaccine had accumulated enough patients with Covid-19 to compare its effectiveness versus a placebo. "This means we may know whether or not our vaccine is effective by the end of October", he said.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorisation Use in the U.S. soon after the safety milestone is achieved in the third week of November", the company's chairman and CEO Albert Bourla said in an open letter. "All the data contained in our US application would be reviewed not only by the FDA's own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency".

In an open letter published on the company's web site, Pfizer (PFE) chairman and CEO Albert Bourla said that there must be certainty that the vaccine is safe and will satisfy regulators' standards.

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Bourla noted, "The timelines above reflect our best estimates of when these important milestones could be achieved".

But experts warn that even when vaccines are approved, it will take many months until they are widely available.

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

The regulatory filing for the vaccine could come as soon as safety data is available in the third week of November, Pfizer said, lifting the company's shares and the broader United States stock market.

A Chinese city is offering Sinovac Biotech's experimental Covid-19 vaccine to essential workers and other high-risk groups as part of a national programme for about $60 (RM 249).

Developed by Siberia-based Vector Institute, EpiVacCorona completed its early-stage human trials in September.

The first batch of Russia's Sputnik-V vaccine against the novel coronavirus was delivered to Venezuela in early October, and 2,000 volunteers have been selected to participate in the trials.

This comes at a time when COVID-19 cases in the US are climbing slightly, but the coronavirus deaths are relatively level this month.

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