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Pfizer and BioNTech announce plan to expand the Covid vaccine trial

17 Sep 2020

Pfizer and BioNTech are moving to enlarge their Covid-19 vaccine's Phase 3 trial by 50 percent, which could allow the company to obtain more data on safety and efficacy and increase the diversity of participants in the research. 

 

In a recent press release these companies said they would increase the study size to 44,000 partakers, up from an initial recruitment goal of 30,000 people.

 

U.S. Food and Drug Administration have been ordered to still approve the move before it goes into effect.

 

The companies continue to expect that by the end of October, a definitive examination of efficacy is possible, "the press release said." The research by Pfizer and BioNTech is likely to be among the first to announce efficacy results from a Phase 3 trial in the United States.

 

It is possible that the extension of the trial will make it easier for the company to prove whether the vaccine is successful against SARS-CoV-2, the Covid-19 virus.

The companies also said the move will allow the study to include a more diverse population.

 

The companies said the research will now include adolescents as young as 16 years old, people, with stable HIV, and also those with hepatitis C or hepatitis B.

 

The companies said that next week, the trial is expected to hit its initial target of 30,000 patients. Moderna, who began his trial on the very same day as Pfizer, said on September 4th that it is working on the diversity of trial participants in his research, "even if those efforts have an effect on the pace of enrollment."

 

The Pfizer / BioNTech study could end earlier than Moderna's, even though, for other reasons, the two started on the same day. Both vaccines need a second shot; after three weeks, Pfizer's are given, and after four, Moderna's. The Pfizer trial also begins to count Covid-19 cases earlier than the Moderna study after the participants receive their shots.

 

But, should they prove successful, the Pfizer / BioNTech vaccine could also prove to be one of the most difficult experimental vaccines to administer. It is important to maintain the vaccine at a temperature of -70 degrees Celsius.

 

Political pressure to move a vaccine quickly has been put in motion, with President Trump saying one could be available before election day. Several drugmakers, including Pfizer, issued a pledge last week not to move a vaccine forward faster than the outcomes of their clinical trials justified.