On 23 November, the science journal Nature published the article, “Why Emergency COVID-Vaccine Approvals a Dilemma for Scientists.”
The article points to the concerns of a number of scientists due to potential safety factors being overlooked in the mad rush to get a COVID-19 vaccine out to the public. On 9 November, drug makers Pfizer (based in New York and New Jersey) and BioNTech (based in Germany) reported successful phase III trials of their vaccines and are now seeking “emergency-use rules” to speed up the release.
As the article points out, “Once a vaccine is granted emergency approval, there is pressure on developers to offer the immunization to trial participants who received a placebo. But if too many people cross over to the vaccine group, the companies might not have enough data to establish long-term outcomes, such as safety, how long vaccine protection lasts.”
Klaus Stohr, who was previously head of vaccine design at the pharmaceutical company Novartis in Massachusetts, called the sped-up process “a real vaccine-development dilemma.”
This potential safety issue was anticipated back on 22 June in an article published by Scientific American magazine: “The Risks of Rushing a COVID-19 Vaccine.” The article states,
“Telescoping testing timelines and approvals may expose all of us to unnecessary dangers related to the vaccine. While preclinical trials to evaluate the potential safety and efficacy of vaccine candidates are likely to include tens of thousands of patients, it is still unclear whether that number will be large enough and a trial will last long enough to evaluate safety for a drug that would be administered to so many.”
The FDA has announced its vaccine advisory committee will meet on 10 December to decide whether to approve the two current vaccines showing successful results. The Nature article points out most every researcher interviewed expects the FDA to grant approval.
But as the website Drugwatch, which reports information from peer-reviewed medical journals, reports,
“Contrary to what most people think, just because a drug or device is FDA-approved, it does not mean the product is guaranteed to be safe. In fact, manufacturers recall about 4,500 drugs and medical devices annually. While the FDA has efforts in place to minimize these safety risks, there are still occurrences where drugs or devices may come to market quickly and lead to safety concerns.”
The FDA was already being criticized for fast approvals of drugs that proved ineffective and, in some cases, deadly. In June 2018, PBS New Hour published an expose titled, “FDA increasingly approves drugs without conclusive proof they work.”
The article stated, “The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world.”
The article quoted Dr. Michael Carome, director of the health research group for the nonprofit organization Public Citizen and former U.S. Department of Hof Health and Human Services official. Dr. Carome said, “Instead of a regulator and a regulated industry, we now have a partnership. That relationship has tilted the agency away from a public health perspective to an industry-friendly perspective.”
