Pfizer plans to seek authorization for Covid-19 vaccine next month

Henrietta Strickland
October 16, 2020

Without further data on how effective the vaccine is and how long immunity from it may last, it's also hard to know what impact any of the shots now in phase III trials will have on controlling the pandemic. The last step is demonstrating that the "vaccine can be consistently manufactured at the highest quality standards".

That October timeline sounded even more aggressive when Moderna CEO Stephane Bancel, known for touting ambitious goals, said his company's shot, which was the first in the U.S.to move into clinical testing, likely wouldn't have data until November.

In mid-August, Russia released the world's first coronavirus vaccine approved for public use, Sputnik V. However, scientists worldwide have cast doubt on the vaccine, as it was registered before the results of phase 3 studies were made available.

United States pharmaceutical giant Pfizer expects to file for emergency use authorization for its COVID-19 vaccine in late November, around two weeks after the November 3 USA presidential election, it said Friday.

Pfizer's Chief Executive Officer Albert Bourla noted in a letter posted on its website that the filing depended on several factors, including data on effectiveness that may or may not be available by late October.

"We estimate that we will reach this milestone in the third week of November", Bourla wrote.

The second Russian vaccine to receive regulatory approval was developed by the Vector State Research Centre of Virology and Biotechnology.

The Russian government also expects that clinical trials for the vaccine can start in Indonesia, which would allow for its registration with the health authority in the country. AstraZeneca's USA trial has been on hold since September.

Sanofi and Translate Bio confirmed that a phase 1/2 trial on humans would begin in the fourth quarter to test for safety and to determine the dosage before a possible final Phase 3 trial. "And the polling shows us that lot of people are reluctant to take it because they think it's not just being driven strictly by the science", he said. Pfizer's vaccine requires two doses, about a month apart.

Is US authorization up to President Trump?

Though President Trump and others have portrayed it as a silver bullet in bringing the rampaging deadly virus to an end, epidemiologists and vaccine researchers tend to portray any COVID-19 vaccine more as one effective tool among many in the fight against the spread of the disease.

The CDC has said that if supplies are limited, the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, people aged 65 years and older and essential workers. The agreement provides the US government an option to purchase an additional 500 million doses.

Other reports by Click Lancashire

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