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Pfizer and BioNTech 'on track' for COVID-19 vaccine regulatory review in October

Pedestrians wearing a protective mask walks past Pfizer Inc. headquarters on July 22, 2020 in New York City. (Photo by Jeenah Moon/Getty Images)
Pedestrians wearing a protective mask walks past Pfizer Inc. headquarters on July 22, 2020 in New York City. Photo: Jeenah Moon/Getty Images

US pharma giant Pfizer (PFE) and its German partner BioNTech (BNTX) have announced that they are on track to submit their vaccine candidate for regulatory review as soon as October.

The companies released fresh data on Thursday of their m-RNA vaccine against COVID-19currently in phases two and three of testing in Germany and the US.

Phase three means mass human testing; Pfizer and BioNTech announced at the end of July that they had begun phase three testing on some 30,000 volunteers between the ages of 18 and 85, in 120 sites globally.

The two companies said in a press release that “across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.”

If they get the required regulatory authorisation or approval is obtained, they said they “currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.”

Pfizer and BioNTech recently entered into an agreement to supply the US government with 100 million doses of their coronavirus vaccine in a $1.95bn (£1.48bn) deal, as part of the government’s Operation Warp Speed — a push to deliver 300 hundred million doses of COVID-19 vaccines by the end of the year.

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BioNtech and Pfizer, AstraZeneca (AZN.L) and the University of Oxford, Moderna (MRNA), Novavax (NVAX), Johnson&Johnson (JNJ), and Germany’s CureVac (CVAC) are some of the leaders in the vaccine-development race, so far.

US-based Moderna also announced the launch of late-stage m-RNA vaccine trials on 30,000 volunteers across the US at the end of July.

M-RNA, or a messenger RNA (ribonucleic acid) are a new type of vaccine. Unlike traditional vaccines, which work by putting weak or inactivated doses of a virus or bacteria into the body to make the immune systems produce antibodies, the m-RNA vaccine works by transmitting a genetic code to cells telling them produce a protein, which in turn activates the immune system.

The head of Germany’s vaccine regulator, the Paul Ehrlich Institute, said this week that the first coronavirus vaccinations for certain groups of people could start as soon as the beginning of 2021.

“If data from phase three trials shows the vaccines are effective and safe, the first vaccines could be approved at the beginning of the year, possibly with conditions attached,” Institute president Klaus Cichutek said in an interview with Funke Media Group.

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