By now you’ve surely heard the good news about the COVID-19 vaccine being developed by Pfizer Pharmaceutical Company in collaboration with a German biotech company, BioNTech. After being given to nearly 44,000 volunteers, only 94 cases of COVID-19 occurred leaving the company to boast a more than 90% rate of efficacy. But it was not announced whether the cases occurred in the half that received vaccine or the half who received placebo.
Pfizer is the drug company, you may recall, that brought us Lipitor and Viagra, two huge money makers. But Pfizer has many other drugs that are of clinical significance.
Each trial participant received two injections, spaced 21 days apart, of either the active vaccine or a placebo. As mentioned, out of 43,538 patients, only 94 cases of COVID-19 developed. That sounds very good to me. The FDA is requiring a minimum of two full months of follow-up data from patients to document safety and efficacy. Only after enough time passes to be certain adverse effects will not occur, will the FDA grant approval for administration to the general public.
Pfizer wants to extend the trial until 164 cases of COVID-19 are recorded to better verify their results. They want to be able to state their vaccine gives “a level of protection on a par with current highly effective childhood vaccines.” They hope to have 15-20 million doses of vaccine available for immunization by the end of 2020.
Pfizer executives purposely waited until after the presidential election to announce these results. They also stated they were “not part of Operation Warp Speed,” the government program that incentivized vaccine development. Pfizer wanted to avoid taking “any government money to pay for research and development.” The U.S. government did, however, pay Pfizer 1.95 Billion dollars to produce 100 million doses of vaccine; no small “subsidy.” More recently, Pfizer received additional money to cover the cost of distribution.
Despite developmental success, many scientists still want to see more data and worry the vaccine’s protection won’t last. Still unknown are the vaccines side effects and length and degree of immunity. Others were impressed expecting less spectacular results. Some “want to know the spectrum of disease that the vaccine prevents.” Others want to know “if the vaccine can prevent asymptomatic, or mildly symptomatic, people from spreading coronavirus.”
Eleven other vaccines, including 4 from U.S. manufacturers, are in late-stage trials. Moderna, Astra-Zeneca, and Johnson & Johnson are three of the more notable prospects. So the horizon shows optimistic signs of the sun coming up and a new era beginning. Our society and economy desperately need an effective, safe vaccine that is declared liability free. We shouldn’t bring a vaccine to market without protecting the manufacturers from lawsuits stemming from adverse reactions that occur years later and were not present during the rigorous trials during development. Opportunistic product liability lawyers will have their claws poised to dig into the flesh of the first company who has an adverse reaction to their vaccine. Companies need protection from these predators, and I hope it occurs.
Public anxiety about COVID-19 is at a very high level. People hate wearing masks, hate not seeing one another, not going to church, not having weddings and funerals, and not being free to enjoy life as it was before last March. A vaccine seems to be the only answer. It certainly became the President’s only hope for re-election. One observer said referring to the vaccine, “I’ve seen some good things, but it is extraordinary and bodes well for us being able to get a handle on the epidemic and get us out of this situation.”
Pfizer’s announcement plus progress from the numerous other manufacturers give us hope. News about other late trial successes should be coming soon, so as soon as I see something, I’ll express my opinion in a blog. There’s a lot of information “out there,” and keeping up with it is a task. I’ll try to do my best.
Since this blog was written, Pfizer has reached the threshold of 164 cases (actual 170) and now claim a 95% efficacy rate. Overwhelmingly, the cases of COVID were in the placebo group. Pfizer will soon file for Emergency Use Authorization from the US FDA.
References: https://www.npr.org/sectional/health-shows/2020/11/09
HTTPS://www.nytimes.com/2020/11/09/health/Covid-vaccine-Pfizer
HTTPS://www.stat news.com/2029/11/09/Covid-19-vaccine-from-Pfizer
