Upping the phase 3 investigational vaccine trial size to 44,000 participants will also allow for the enrollment of new populations.
Pfizer and BioNTech are planning to expand the enrollment of a phase 3 COVID-19 vaccine trial from 30,000 to 44,000 participants. Pfizer’s CEO has announced that the firm hopes to have a coronavirus vaccine beginning to roll out by the end of the year.
Upping the phase 3 trial size to 44,000 participants will allow for the enrollment of new populations, according to a press release published by Pfizer.
The BNT162 mRNA vaccine program uses messenger RNA, unlike other adenovirus based candidates.
The trial expansion is intended to include adolescents as young as 16 years of age and people living with HIV, Hepatitis C, or Hepatitis B infection, as well as provide additional safety and efficacy data.
In the statement announcing intent to expand the trial, representatives of the 2 companies also estimated when efficacy results will be available.
“The pivotal trial is event-based and there are many variables that will ultimately impact read-out timing. As stated previously, based on current infection rates, the companies continue to expect that a conclusive readout on efficacy is likely by the end of October,” the statement reads.
While Pfizer is a household name in pharmaceuticals, not everyone is likely to have heard of BioNTech.
According to the Pfizer release, the company’s collaborator Biopharmaceutical New Technologies is “a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.”
The US government will pay the companies $1.95 billion upon the receipt of the first 100 million doses of BNT162, following US Food and Drug Administration authorization or approval. The US can also acquire up to an additional 500 million doses.
A recently released manuscript describes key safety and immunogenicity data from the US phase 1 trial for the BNT162b2 vaccine candidate, which at 30μg recorded 7 days after the second dose elicited SARS-CoV-2-neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults.
In addition, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants.
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