After Sputnik V, Russian Federation grants approval to 2nd COVID-19 vaccine EpiVacCorona

Johnson & Johnson pauses vaccine trial

Despite President Donald Trump's repeated promises of a vaccine before Election Day, scientists had been cautioning that it's unlikely data showing a leading shot actually works would come until November or December. The vaccine named EpiVacCorona comes after Russian Federation recently granted similar approval to its first COVID-19 vaccine named Sputnik V. Notably, Sputnik V is also the first vaccine candidate in the world to attain regulatory approval.

Pharmaceutical giant Pfizer says that the earliest it can request emergency authorization of its COVID-19 vaccine is the third week of November - and that's if everything goes well.

In a significant development, Russian Federation announced on Wednesday (October 14) that it has granted regulatory approval to another coronavirus COVID-19 vaccine.

AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States as early as October but its USA trial has been on hold since September.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Use Authorization in the USA 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. Pfizer/BioNtech said it may have data as early as October, but that it would wait for safety data it expects in the third week of November to file with US regulators.

The CDC anticipates that up to 700 million doses of vaccine will be available in April of 2021, enough to vaccinate all Americans because most vaccines in development require two doses per person.

Bourla's emphasis on having data in October "is what got many of us concerned, whether it was inadvertently playing into the political pressure or just because the incentives were aligned", Topol said.

"We estimate that we will reach this milestone in the third week of November", Bourla wrote. "We're still waiting for a response", Vorobieva said in an interview with The Jakarta Post on Thursday.

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

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA. The vaccine must reduce the risk of infection by at least 50% in order to be considered for FDA emergency authorization.

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

US drugmaker Pfizer Inc with German partner BioNTech SE, US biotech Moderna Inc and Britain-based AstraZeneca Plc in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials as early as October or November.



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