Warp Speed Gift! Pfizer Says COVID Vaccine 90% Effective in Phase 3 Trial Analysis, and So Is Sputnik V
Nov. 9, 2020 (EIRNS)—The pharmaceutical manufacturer Pfizer, which is currently in the lead to produce a vaccine for COVID-19, has announced that its vaccine is over 90% effective in preventing the infection. One headline called the event “a great day for science and mankind,” and it is the gift of the Warp Speed vaccine-development “crash program” of President Donald Trump.
Russian Health Ministry research institute director Oksana Drapkina then said of the Sputnik V vaccine, already being administered to target populations in Russia, “Based on our observations, it is also more than 90%. The appearance of another effective vaccine—this is good news for everyone.”
An interim analysis of data from the ongoing Phase 3 trial of Pfizer mRNA vaccine reviewed the experience so far. The test population is 44,000 participants, half getting the vaccine and half getting a placebo salt-water shot. So far there have been 94 cases of COVID-19 in this entire 44,000 population, with fewer than 9 of these in the vaccinated half of the participants, and 86 in the placebo group. The head of Pfizer’s vaccine research and development, Kathrin Jansen, told the Washington Post, “I would say it’s an historical moment. Something like this has never happened before. First of all, the world was faced with such a terrible situation, the pandemic, and being able in such a short time to go through what usually takes many years.” The interim results were analyzed by an independent committee, which found no serious safety concerns.
The number of positives in a vaccine Phase 3 trial needed to show statistical efficacy is usually in the range of 160 cases. However, statistical significance tests can show efficacy at lower numbers of total positives if there is a dramatic difference between the two populations. In the case of the Pfizer vaccine, the difference in positives is so dramatic that efficacy could be strongly supported at a lower number of total positives. This means that it is highly likely that more than a month ago, in early October, there would have been sufficient evidence of efficacy for an emergency approval.
Regarding safety, there were no significant safety concerns as of early October, after thousands of study participants had been vaccinated and observed for 1 month or more. Given the extreme urgency of getting a vaccine to the most vulnerable sections of the population, such as nursing home residents, an emergency use authorization would have been justified in early October regarding safety concerns, accompanied by an advisory to use in the most vulnerable populations first. It is a scandal that this early-use authorization process was held up by FDA’s vaccine program head, Peter Marks, with an arbitrary safety observation period that happened to stretch two weeks past the presidential election. Dr. Marks is head of the Center for Biologics Evaluation and Research at the Food and Drug Administration.
The Pfizer vaccine uses a new technology, messenger RNA, which contains the genetic code for the virus spike protein. The mRNA is encapsulated in very small lipid particles, and is injected into the subject. The mRNA enters the subject’s cells, and codes for the production of the virus spike protein, which then stimulates an immune reaction. There is no virus in the vaccine. Another company, Moderna, has developed this technology over the past 10 years, and is also in Phase 3 testing. The advantages of an mRNA vaccine include that a live virus containment lab is not necessary. The same delivery system can be used for other mRNA vaccines or therapies which require only a change in the mRNA code, and because production is done entirely in the test tube, the process can be easily scaled up as needed.
