Health officials rejected Pfizer’s insistence for a COVID booster – for many reasons

Rows of small glass bottles.
Enlarge it / An undiluted bottle of Pfizer COVID-19 vaccine.

Pfizer had planned to give a personal explanation to U.S. health officials about its case for the filming of COVID-19, but U.S. and global public health officials did not hesitate to launch the idea publicly, calling the booster shots unnecessary at this time and unethical in facing great injustices in the global vaccine supply.

Pfizer and its vaccine partner BioNTech made headlines last Thursday with the announcement that it will seek permission from the Food and Drug Administration in the coming weeks to increase suffering to its two -injection regimen. The companies suggest that a third shot is needed between six and 12 months after the second dose. During this period, immunity to the coronavirus decreased, the company said, especially in the elderly. The third shot, they said, could increase antibody levels five to 10 times than those seen after the first two.

But health officials quickly dismissed the booster talk last week, and the response has only intensified over the past few days.

The U.S. Department of Health and Human Services issued an unusual joint statement late Thursday from the Centers for Disease Control and Prevention and the Food and Drug Administration. The statement read bluntly, “Americans who have been fully vaccinated do not need an alarm at this time.”

Vaccine requirements

The statement went on to say that U.S. health agencies are monitoring every possible need for booster shots in the future. But health officials will not rely entirely on data from vaccine makers, who clearly have a conflict of interest to decide whether more of their shots are needed.

The agency wrote:

FDA, CDC, and NIH [the National Institutes of Health] engage in a scientific and thorough process to consider whether or when a booster may be needed. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies but does not rely on such data exclusively. We continue to review any new data as it becomes available and will provide information to the public. We are prepared for booster doses if and when science shows that they are needed.

Officials with the World Health Organization went a step further on Monday during the periodically scheduled COVID-19 press briefing. In addition to noting the lack of evidence supporting current amplifier needs, they rebuked the discussion of giving a third dose to people in rich countries while many low- and middle-income countries do not have a supply of vaccines to give the first dose to even the most vulnerable citizens, i.e. frontline health workers and the elderly.

“What part of ‘this is a global crisis’ that we don’t get?” Mike Ryan, executive director of the WHO Health Emergency Program, said at the briefing. “This is still a global crisis, and it’s time to protect the most vulnerable in our society.” If we fail to protect vulnerable people and keep talking about promoters, “then I think we will be judged … I think we will look back with anger and we will look back with shame.”

Ryan and other experts with the WHO state that the primary purpose of vaccination is to prevent severe illness and death, which current vaccines do very well. But so far, the main impetus for considering a third dose is to protect against mild infections that may arise as the effectiveness of the vaccine diminishes over time.

Preventing mild illness in those who have been vaccinated should not be a priority when vulnerable, unvaccinated people are still dead, Ryan and others said. Increased production of vaccines that can be used as boosters should be used “to protect the most vulnerable, protect our front-line health workers anywhere in the world, [and] bring deaths and hospitalizations and ventilators from this outbreak, ”Ryan said.

“Very disappointing”

Moreover, as the pandemic coronavirus continues to rage through unvaccinated populations, it still has more chances to develop into a new, more dangerous variant. Current vaccines are largely effective against current variants, including delta, a highly contagious variant that first appeared in India amid a mostly unvaccinated population. But the effectiveness of the vaccine may not withstand future variants. And if there was a variant that could completely avoid the immune response from the current vaccine, that would make the third dose not only ethically questionable but also useless.

WHO Director-General Tedros Adhanom Ghebreyesus spoke at a briefing on a “two-lane pandemic”, in which unvaccinated countries continue to suffer, and highly vaccinated countries have a false sense of security that the pandemic is largely over for them.

Distributing vaccines fairly is not just the right thing to do, Dr. Tedros emphasizes – this is for everyone’s self -interest.

When you consider that “many countries have not even started vaccinating, and other countries have vaccinated most of their population with two doses and [is] now switching to the third dose, which is a booster, it’s actually not just disappointing, “he said.” It’s very disappointing. That doesn’t make sense. Illogical. “

On Saturday, The Washington Post reported that Pfizer and BioNTech plan to meet with U.S. officials about their case as promoters. According to those familiar with the meeting plan, those invited included Anthony Fauci, President Biden’s chief medical adviser; Francis Collins, NIH director; Rochelle Walensky, CDC director; Janet Woodcock, acting FDA commissioner; David Kessler, chief science officer for the COVID-19 response; and Surgeon General Vivek H. Murthy. The Post reported that it was unclear who among them would be present. The meeting was initially scheduled for Monday, but the Post reported that the scheduling could change.

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