What Pfizer's COVID Vaccine Approval Means
The FDA has fully approved Pfizer’s COVID-19 Vaccine for 16-year-olds and up. The MRNA vaccine has been researched in other coronaviruses for years.
It's been 97 days since Pfizer started submitting data for their full approval application.
Part of that time for the FDA includes inspecting the vaccine manufacturing facilities AND clinical trial sites, even monitoring individual patients and going through data of tens of thousands of patients and, given enough time, to also follow them for safety.
Based on those results, the vaccine was 91% effective in preventing COVID-19 disease.
These numbers are from before the Delta variant surge. Early research shows immunity from the MRNA vaccines goes down after roughly 6-8 months.
The FDA's licensure doesn't cover boosters. FDA must approve that separately. The Biden administration is planning for boosters starting in the fall, but the FDA and CDC still must OK it.
The FDA already is allowing emergency use of a third dose of Pfizer or Moderna shots for people with severely weakened immune systems.
Front line health care workers, who have seen a vast majority of those severely sick unvaccinated, tell Newsy they're hopeful this will help in the pandemic fight.
"This stamp of approval is so good, because it will say, look, we have done what we would have done for every other vaccine," says Neysa Ernst, Nurse Manager at Johns Hopkins Hospital. "For your shingles vaccine, for your pertussis vaccine, for your tetanus shot."
The FDA only expanded Pfizer’s vaccine emergency approval for 12-to-15-year-olds on May 10, so it's too early for that group to be included in the full license.
Also, still to be decided is vaccination of children under 12. Both Pfizer and Moderna are studying young children, and those findings are expected in the fall.
FDA says it will continue to study the Pfizer vaccine even after approval, including safety studies for pregnancy.
The hope here is that groups that have been hesitant will get vaccinated now. For example, even though the CDC recommends it, right now only about 1 in every 4 pregnant people have gotten a COVID vaccine.
Moderna defends vax price hike, despite billions in taxpayer funding
The company is planning to raise the price of its COVID-19 vaccine from about $26 per dose up to $130 per dose.
What living with long COVID is really like
Scripps News talked to a dozen people with long-term COVID symptoms about their current experience and their hope for the future.
New data links COVID-19 pandemic's origins to raccoon dogs
The discovery does not prove that raccoon dogs or any other animals infected with COVID triggered the pandemic.
Texas police: Migrants found 'suffocating' in train; 2 dead
Migrants routinely travel through Uvalde, Texas, where the migrants were stopped, often leading to high-speed vehicle pursuits.
Pennsylvania chocolate factory explodes; 5 dead, 6 missing
Some residents were displaced from a neighboring apartment building that was damaged in the explosion.
Trump rallying supporters in Waco ahead of possible charges
The rally comes as Trump has berated prosecutors, encouraged protests and raised the prospect of possible violence should he be criminally charged.