The FDA is under the gun. Both Pfizer and Moderna have requested Emergency Use Authorization (EUA) for their respective mRNA COVID-19 vaccines. The White House summoned Dr. Stephen Hahn, Commissioner of the FDA, to explain the agency’s seemingly slow pace. Britain gave the Pfizer and BioNTech coronavirus vaccine the green light on December 2, 2020. Why should people in the UK get access to the vaccine before American citizens?
The UK Approval vs. the FDA’s EUA:
British regulators accept the data as presented by the drug companies. The commission on Human Medicines (CHM) started doing a “rolling review” in October. These scientists reviewed the “available data” as fast as possible. During this expedited process the CHM relies heavily on the companies to do the number crunching.
The FDA, on the other hand, follows Ronald Reagan’s admonition to “trust but verify.”
According to the Wall Street Journal (Dec. 2, 2020):
“Food and Drug Administration Commissioner Stephen M. Hahn defended his agency’s vetting process for Pfizer Inc.’s Covid-19 vaccine, saying a thorough and meticulous review is needed to assure a skeptical public of the vaccine’s safety and effectiveness.
“In an interview with The Wall Street Journal, Dr. Hahn said his agency has had 150 people working days, nights and weekends in parallel teams to review the test data submitted by Pfizer and German partner BioNTech SE.”
The FDA scientists actually review the raw data rather than accept the summaries from the pharmaceutical manufacturers. An outside advisory committee will meet on December 10, 2020, to review the FDA’s data analysis for the Pfizer/BioNTech vaccine and make a recommendation. The Moderna meeting will occur on December 17, 2020.
Who Will Get Access to the Vaccine and When?
It is anticipated that the first COVID-19 vaccines will be administered in the UK starting Monday, December 7th. It will likely be at least a week or two after that for Americans to have access to the vaccine. That’s assuming the FDA issues an Emergency Use Authorization to Pfizer and BioNTech shortly after the advisory committee meeting on December 10, 2020.
In Britain, the Joint Committee on Vaccination and Immunization (JCVI) has issued its priority list. Here’s how it breaks down:
Highest priority goes to 1) residents and staff in residential care homes. 2) Frontline health and social care workers are also considered high priority for access to the vaccine. People over the age of 80 are also high risk and therefore top tier for access to the vaccine.
Next 3) come all those over the age of 75. 4) includes people 70 or above and “extremely vulnerable individuals.” 5) represents “all those 65 years of age and over.” 6) equals all individuals aged 16 years to 64 years with underlying health conditions which put them at higher risk of serious disease and mortality. 7) those 60 years and over. 8) 55 years of age and over and 9) all those 50 years of age and over.
The Brits suggest that:
“It is estimated that taken together, these groups represent around 99% of preventable mortality from COVID-19.”
Access to the Vaccine in the U.S.
An independent advisory committee has advised the CDC that health care workers are at high risk, as are vulnerable people in nursing homes or long-term care facilities. They should all be first in line. States have autonomy in deciding how to allocate vaccine distribution, but it is likely that the CDC recommendations will be followed.
Once this first tier of vaccinations is complete, early in 2021, it is expected that essential workers will be next in line to have access to the vaccine. That includes first responders, police, fire fighters, teachers, food workers, and people employed in public transportation. Older people and those with underlying health conditions will also be close behind.
The CDC’s Advisory Committee on Immunization Practices (ACIP) offers these goals for access to the vaccine if supply is limited:
• Decrease death and serious disease as much as possible
• Preserve functioning of society
• Reduce the extra burden the disease is having on people already facing disparities
• Increase the chance for everyone to enjoy health and well-being
What Do You Think?
I have made it clear that I will be getting the two shot program when I qualify for access to the vaccine. You can read why at this link:
I’m Getting the COVID Vaccine Because I Had Polio
There are now two vaccines under review by the FDA, Pfizer’s and Moderna’s. Will people get the COVID vaccine? Many say no, but I’m on board!
We know that many people remain skeptical. But at last count, over 100,000 people are hospitalized with COVID-19 and we are closing in on 3,000 deaths daily. These are grim statistics. It will be months before we can turn this pandemic around, even with access to the vaccine.
In the meantime, our healthcare system is being stretched to its limits. Dr. Robert Redfield, head of the CDC, has warned that we could reach “close to 450,000” deaths by February unless people interrupt the surge with careful behavior. We just hope that we can avoid achieving the tragic number of 675,000 deaths that occurred during the influenza pandemic of 1918.
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