Pfizer Signals Time for COVID Booster; FDA and CDC Disagree For Now
The COVID-19 pandemic hasn't diminished despite the number of vaccines available
The coronavirus even spawned a more dangerous variant, the Delta, first discovered in India
However, a vaccine manufacturer claims its vaccine is waning, which requires a third dose to optimize the protection level
Pfizer said Thursday that its COVID vaccine is found with diminishing immunity
It is now working on a booster dose and will soon publish data about it
Once the data is available, it will also submit details to regulators, including the US FDA and European Medicines Agency
Pfizer plans to seek emergency use authorization for the booster in August
Though, two federal agencies in the US didn't agree with Pfizer
The agencies said that companies alone can't make decisions whether a booster dose is needed
Just hours after Pfizer made the announcement, the FDA and CDC released a joint statement
"Americans who have been fully vaccinated do not need a booster shot at this time," they said
The statement noted that fully vaccinated people are "protected from severe disease and death, including from the variants," currently invading the US like Delta
But those who aren't vaccinated remain at risk of severe symptoms, hospitalization, and premature death
Both two agencies explained that a "rigorous" process is required to determine if a booster is necessary
This process considers laboratory, clinical trial, and cohort data, yet not exclusively relying on those
The World Health Organization told CNN that no one knows whether boosters will maintain protection against COVID due to limited information
There's no concrete evidence yet on how long current doses will last
Plus, no sufficient data has determined if these boosters are truly beneficial or which groups will benefit the most
But why did Pfizer suddenly make an announcement without seemingly coordinating with federal agencies?
The company likely based its decision on the data released from the Israel Ministry of Health
That data suggested dwindling efficacy on preventing infection and symptomatic disease at 6 months after vaccination
While preventing severe disease remains high even at 6 months
The announcement can be a big deal worldwide
Not every nation has vaccinated at least 50% of its population
The booster dose may mean expanding protection among fully vaccinated but may restrict access of those unvaccinated due to limited resources
Right now, the best approach is to have as many people fully vaccinated against COVID-19