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Pfizer begins manufacturing COVID-19 vaccines ahead of expected approval

US pharmaceutical giant Pfizer has begun manufacturing hundreds of thousands of doses of its COVID-19 vaccine ahead of its expected approval next month.

The UK’s Daily Mail on Sunday published video showing a manufacturing plant in Puurs, Belgium with thousands of doses of the vaccine coming off the production line.

Pfizer said last week it expects to file for emergency use authorization for its COVID-19 vaccine in late November, around two weeks after the November 3 US presidential election.

The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November.

The company has said it hopes to make 100 million doses available this year and a massive 1,3 billion available in 2021. Each recipient will need two doses.

“It was great to see the first vial coming off the manufacturing line,” Pfizer UK head Ben Osborn told the Daily Mail. “It just brought a tremendous smile to my face to see all of this work actually result in a product.”

In July the US announced it will pay Pfizer nearly $2 billion for a December delivery of 100 million doses of a COVID-19 vaccine the pharmaceutical company is developing. The US could buy another 500 million doses under the agreement.

The agreement is part of US President Donald Trump’s Operation Warp Speed vaccine program, under which multiple COVID-19 vaccines are being developed simultaneously. The program aims to deliver 300 million doses of a safe and effective COVID-19 vaccine by January 2021.

Under the initiative, the government will speed development and buy vaccines — before they are deemed safe and effective — so that the medication can be in hand and quickly distributed once the FDA approves or authorizes its emergency use after clinical trials.

The Pfizer announcement last week means the United States could have two vaccines ready by the end of the year, with Massachusetts biotech firm Moderna aiming for November 25 to seek authorization.

The Food and Drug Administration (FDA), which authorizes pharmaceuticals for distribution in the US — asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.

The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large scale production.

Pfizer and Modern, both funded by the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses.

Source: TOI and AGENCIES