Calling the Miraculous Great Day for Science Into Question

Pfizer/BioNTech vaccine has 90% efficacy. Justin Lane/EPA

"[Early data suggests the BNT152b2 vaccine is more than 90 percent effective, a] Great day for science and humanity."

"As the study continues, the final vaccine efficacy percentage may vary [from its initial 90%]."

"The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 percent, at seven days after the second dose."

"Today is a great day for science and humanity."

Pfizer Inc. press  release

"It's well known in clinical trials that sometimes when you have really, really positive effects in the interim analysis, those positive effects get smaller as you complete the trial."

"You'd really need to see the full array of safety information to have a critical appraisal of the vaccine."

"If there is a reversal of fortunes for this vaccine, people in the public begin to have more doubts about what companies or various sponsors are reporting ... You really want to be confident that you have worked out all the kinks, that you have reliable findings before you go public."

"Presumably, Pfizer is making this information public because they think it ought to inform some people's decisions. Why not wait until you have carefully vetted the data, that you've completed the trial, before you issue these results?"

Jonathan Kimmelman, professor of biomedical ethics, McGill University 

"[A vaccine that provides over 90 percent protection against COVID-19] would be absolutely amazing and would definitely go a huge way to leading us out of the pandemic."

"I just want to see the evidence." 

"Does [the Pfizer/BioNTech vaccine] attenuate the disease? Does it reduce spread to other people?"

Dr.Andrew Morris, infectious diseases specialist, Toronto

The Conversation

 

Successful vaccines are developed to produce a dual result; protect the individual who has been vaccinated from becoming infected with the disease while protecting the next person he comes in contact with from being infected. Many experts in the field of epidemiology were taken by surprise when they read the release from Pfizer, since the acceptable minimum target the U.S. Food and Drug Administration felt would be the minimum for it to grant emergency use authorization for such a vaccine stood at 50 percent effectiveness.

Pfizer's press statement sent global stock markets upward, and hope to spring into the minds of a public weary of lockdowns and concerns over contracting the illness that has been so destructive globally and in particular to the United States in caseloads, hospitalizations and deaths. The basis for the pharmaceutical company's confidence in releasing the results of its third-stage trial before peer review or publication was the conclusion the vaccine appears safe, no serious concerns surfacing, but information on safety yet to be assembled.

The statement of confidence and jubilation is based on an interim analysis. The stakes are "beyond imagination", Albert Bouria, chairman and CEO of Pfizer stated. Experts in the field are somewhat less convinced, urging caution rather than rushing to a somewhat rash conclusion, pointing out that there is as yet too much unknown; whether the vaccine prevented serious infections, or mainly mild cases. Throw in that it's too soon to know how long any immunity that does result from the vaccine will continue to protect from the disease.

The Conversation

 

The statement by Pfizer and German partner BioNTech reflected an early analysis of the final stage Phase 3 trial to determine the new vaccine's effectiveness. Either the experimental vaccine, administered in two stages, or a placebo was used with volunteers, no one knowing which was apportioned to whom. The vaccine known as BNT152b2, has been designed to target the spike protein surrounding the surface of the virus causing COVID-19; a formula also used by other vaccine candidates.

The fact is, nonetheless, that a 90 percent efficacy rate has been reported; vastly superior to the 50 percent minimum target set by the US. Food and Drug Administration. The trial is set to continue until such time as there are 164 confirmed COVID cases among the total 44,000 volunteers receiving both doses of the experimental vaccine. Of that number 94 contracted cases of COVID-19, hence the 90 percent success designation.

Dr. Anthony Fauci ... Al Drago - Pool/Getty Images 

"It's a really good day for biomedical research and clinical application of biomedical research. This is very good news looking forward."

"[The result] validates the mRNA platform, [which could indicate that a separate mRNA vaccine developed by Moderna could also have positive results]." 

"[This] validates greatly [the virus' spike protein as the immune-response target, which is important because it's also the target for] virtually every one of the other vaccines."

"It's not only immediate good news, it really is optimistic about what's going to roll out in the next several months with the other vaccines."

Dr.Anthony Fauci, infectious disease expert, director, U.S. National Institute of Allergy and Infectious Diseases