Pfizer's (NYSE: PFE) CEO Dr. Albert Boula made remarks to the International Federation of Pharmaceutical Manufacturers & Associations on Thursday that the pharmaceutical's coronavirus vaccine candidate, designed in partnership with BioNTech (NASDAQ: BNTX), could produce results from its Phase III trial by the end of October. Boula stated that once the company determines that the candidate is both safe and effective from the 30,000 participant study, it will immediately apply for regulatory approval from the U.S. Food and Drug Administration (F.D.A.).
Boula stated that about 23,000 people have enrolled in the company's late-stage clinical trials at this time, with the drugmaker coming close to its goal of 30,000 participants. Boula added that a good portion of volunteers have already received the second dose of the potential vaccine, with the trial testing the experimental mRNA vaccine with two doses given about 28 days apart.
To prove the vaccine is effective, Pfizer--alongside other major COVID-19 frontrunners like AstraZeneca (NYSE: AZN) and Moderna (NASDAQ: MRNA)--are giving half of their study participants the vaccine candidate and the other half a placebo. From there, researchers will wait to see which group develops the most COVID-19 infections during a set period of time. If significantly more participants develop COVID-19 infections in the placebo group than the vaccine candidate group, researchers may concluded it as evidence that the vaccine is effective.
Yet, due to the U.S. Centers for Disease Control and Prevention's (C.D.C.) new Nov.1 guideline for states to approve vaccine distribution centers and now Pfizer's aggressive vaccine timeline, many health experts are concerned that the vaccine may be becoming politicized to coincide with the Nov. 3 U.S. presidential election.
U.S. Health and Human Services (H.H.S.) Secretary Alex Azar disagrees with the assumption that the vaccine's potential timeline has anything to do with politics, telling "CBS This Morning" Thursday in an interview: "It has noting to do with elections. This has to do with delivering safe, effective vaccines to the American people as quickly as possible...Whether it's Oct. 15, whether it's Nov. 1, whether it's Nov. 15, it's all about saving lives but meeting the F.D.A. standards of safety and efficacy."
Azar stated that the C.D.C.'s deadline was made by Dr. Nancy Messonnier, director of the C.D.C.'s National Center for Immunization and Respiratory Diseases, as well as other C.D.C. staff. The vaccine data will also be reviewed by independent experts.
Ventilator Update
Back in the beginning of the coronavirus outbreak in the United States, the Trump administration made multiple, large emergency contracts with manufacturers to produce ventilators for the U.S. National Strategic Stockpile, which at the time did not have enough machines to fight severe infections. Six months later, the H.H.S. affirmed that the stockpile has now reached maximum capacity, with nearly 120,000 machines now available for state health officials.
According to the Associated Press, the H.H.S. has terminated its outstanding contracts with the manufacturers Hamilton Medical and Vyaire Medical, as well as Phillips's (NYSE: PHG) massive $647 million deal to deliver 30,700 ventilators.
General Motors (NYSE: GM) announced earlier this week that is had completed its $489 million contract to manufacture 30,000 ventilators for the federal government. Ford (NYSE: F) also finished making 50,000 breathing machines for the U.S. under its $336 million deal.