(Reuters) – The United States is reviewing the need for a third COVID-19 booster shot among residents who have already been vaccinated but needs to see more data to know if additional shots could raise people’s risk of serious side effects, a U.S. health official said Tuesday.
The official said the second dose for two-shot COVID-19 vaccine regimens was associated with higher rates of side effects, suggesting a third dose could potentially come with even greater risks.
Jay Butler, deputy director at the U.S. Centers for Disease Control and Prevention, said during a media briefing:
“We’re keenly interested in knowing whether or not a third dose may be associated with any higher risk of adverse reactions, particularly some of those more severe – although very rare – side effects” … READ MORE.
When and how will we know if we need Covid-19 booster shots?
By STAT staff July 12, 2021
There’s a lot we don’t yet know about the data behind Pfizer and BioNTech’s renewed push to change their two-shot Covid vaccination series to a three-shot regimen.
But as various factions bicker about whether a third shot is going to be needed, one thing is certain: The final decision will not rest with the companies.
Public health officials, not pharmaceutical executives, will be making the final call on when and whether booster shots will be needed. Pfizer and other manufacturers will surely try to push for approvals; Moderna is already testing a Delta-variant-specific booster.
Depending on how their conversations go with vaccine regulators at the Food and Drug Administration, companies may apply for a change to their emergency use authorizations (or to the vaccine license, if they secure one before applying to change their vaccine label to a three-dose one).
But unless the FDA agrees to the change, and unless the Centers for Disease Control and Prevention recommends use of an additional booster — in some or all of the people who got the Pfizer shot — this will remain a two-dose vaccine.