Pfizer, Moderna to File for Emergency Authorization of Vaccine: What Next?

Marco Green
November 20, 2020

"We are working at full speed", he told AFP in a Zoom interview, confirming that the companies planned to apply for emergency use authorization of their jab in the U.S. on Friday, while European regulators will receive another batch of data "next week". According to the companies, the application will be sent to the United States authorities on Friday.

"Filing in the USA represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential", Pfizer CEO Albert Bourla said in a statement.

Government officials and private companies are ready to distribute the vaccines - both were about 95 percent effective in large trials - to all parts of the country, he said. Pfizer and BioNTech expect to produce a total of 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Prof Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the full data would have to be submitted to bodies like the US Food and Drug Administration and the European Medicines Agency for approval.

"We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world". Although questions have been raised on the infrastructure required to store the vaccine, US health officials have confirmed that freezers required to store Covid-19 vaccines are in place at health systems that are preparing to administer the initial doses. "Widespread success of coronavirus vaccines would be a huge boon to the world's health, because Pfizer and BioNTech alone can not meet the full demand".

Adding to the encouraging 95 percent efficiency data for the Pfizer product is the fact that efficacy was found to be consistent across all age-groups - a primary concern for a disease that hits the elderly the hardest - as well as genders and ethnicities.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations, it will be months before large-scale rollouts begin in either country. Canada signed a deal with the company in August to secure 20 million doses of the vaccine in 2021.

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That means anyone offered an emergency vaccination must get a "fact sheet" describing potential benefits and risks before going through with the shot, she said.

Pfizer's vaccine must be shipped and stored at freezing temperatures of -70 degrees Celsius from the moment they are bottled to the time they are ready to be injected. The most common adverse event rated as "severe" in the trial was fatigue, in 3.7 percent of participants after the second dose.

Henry said that they are working on how they will roll out the vaccine and some of the logistical challenges that come with both vaccines.

Sahin said he was "very confident" his vaccine was safe, a day after Pfizer and BioNTech announced that a completed study of their trial - involving some 43,000 volunteers, more than 21,000 of whom received the jab - showed no serious side effects. Johnson & Johnson said it is on track to deliver data this year.

Traditional virus vaccines use actual viruses that can take months or years to develop. Pfizer only recently began testing the vaccine in children as young as 12.

Moderna too is likely to apply soon for the emergency authorization of its own vaccine.

Other reports by Click Lancashire

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