FDA panel recommends approval of Pfizer vaccine, 17 to 4. But why did 4 oppose?

As expected, the FDA’s independent vaccine advisory committee recommended approval of the Pfizer vaccine yesterday, “17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding”.

CBS News

A federal advisory panel on Thursday recommended the emergency use of Pfizer’s COVID-19 vaccine. The Food and Drug Administration is expected to approve the drug, kicking off a massive nationwide operation to get nearly 3 million doses of the vaccine to hospitals and drug stores across the country. The experts voted 17 to 4 in favor of recommending the drug for emergency use for people aged 16 years and older, with one of the members withholding. Health care workers and nursing home residents will be among the first to get the vaccine.  …….. Clinical trials showed the Pfizer vaccine was nearly 95% effective for adults 18 to 64 and was just as effective for people of all ethnicities. However, some groups — people with weak immune systems, individuals with severe allergic reactions, and pregnant women — could be restricted from getting the shot. However, British health officials on Wednesday warned that people with a history of “significant” allergic reactions to vaccines, medicine, or food should not be given Pfizer’s vaccine. Hahn said the FDA is working closely with its partners in the U.K. to understand what happened with the allergic reactions. “We study the data very carefully to say who should not receive the vaccine and these are the things the FDA does to ensure the safety and effectiveness” of the drug, Hahn said Thursday.

The advisory committee’s recommendation will probably lead to FDA approval by the weekend. The consensus is that the vaccine is safe and 95% effective. The Covid-19 pandemic is clearly out of control and there is a fear – quite justified – that without widespread acceptance of the vaccines the pandemic may continue unchecked. The Spanish flu pandemic (1918 – 21) lasted almost 3 years without any vaccine. Even with widespread and effective vaccination against Covid-19, this pandemic is set to last for at least two years until Spring 2022. Currently there is a widespread, global “information campaign” in favour of vaccination. Sometimes the simplistic and unnuanced messages are, I think, counter-productive. The WHO and UN information programs, in particular, talk down to the “great unwashed” and come close to being brainwashing attempts.

It can be expected that all members of an expert panel on vaccines will generally be in favour of vaccines. A key question then is why 4 of the expert panel did not recommend approval. In the current climate the dissenting expert views are of special importance. Unfortunately there is not much reporting of their views (with some exceptions).

The WSJ has some details:

Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine, said she dissented from the recommendation vote because there isn’t enough data justifying including 16 and 17 year olds in an emergency authorization. …. Oveta Fuller, a virologist at the University of Michigan Medical School, also dissented, saying in an interview that she would like to see at least two more months of data on trial participants that could help determine whether the vaccine reduces transmission.

The issue of using placebos in double-blinded trials for some patients and denying such patients vaccines came up (of effectively using humans as guinea-pigs). This is not really an ethical question at all, though the medical profession assuages its conscience by presenting it as such.

……. Doran Fink, deputy clinical director of the FDA’s division of vaccines, said further evaluation of the vaccine after its release will be necessary to see if its benefits continue to outweigh its risk, and whether any labeling changes will be required. Dr. Fink also addressed one major topic that has been in question—whether patients in the Pfizer trial who were randomly assigned to placebo should automatically be switched over and get the vaccine. FDA staffers told the committee they shouldn’t.

Steven Goodman, a Stanford University School of Medicine dean and epidemiologist, described that choice in testimony before the panel as an “ethical dilemma” in which both answers—getting vaccines to placebo patients and developing long-term safety and effectiveness—are right, and neither is unethical. ….. Marion Gruber, director of the FDA’s office of vaccines (and no relation to Bill Gruber), said she is concerned that if there is an unblinding of patients, that might limit the ability of the study to gather enough data about the vaccine’s safety.

Of course, there is no ethical dilemma. It is a simple case of the one being over-ruled by the many. Those patients involved in trials who get placebos instead of the vaccines are effectively human guinea-pigs whose health (and lives) are being adventured, without their knowledge, “for the common good”. Guinea-pigs (human or not) are not required to be told, or to understand, their fate. Their role is only to be counted in the appropriate column.

Throughout human history “the few” have always been sacrificed for “the many”. That, after all, is the essence of democracy. The reality is that the health of those receiving placebos in a vaccine trial is always subordinated to the results of the trial.


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