By Ana Martinez-Ortiz
Earlier this week the U.S. Food and Drug Administration approved the Pfizer COVID-19 vaccine. This is the first COVID-19 vaccine to be approved by the FDA.
The Pfizer vaccine, which will now be marketed as Comirnaty, is approved for individuals who are 16 and older and remains available under emergency use authorization for individuals ages 12 to 15. The Pfizer vaccine first became available in December 2020 for eligible adults and later was approved for youth in May 2021.
Dr. Bechara Choucair, a White House vaccinations coordinator, noted that many people were waiting for the COVID-19 vaccine to be approved by the FDA before receiving their first dose.
“For those folks who have been waiting for that approval, now is the time to go ahead and get vaccinated,” Choucair said. “It is a key milestone in our nation’s fight against COVID-19.”
People who remain unvaccinated continue to be at risk of contracting the virus, being hospitalized and possibly dying, he said, adding that the majority of people hospitalized or dying from COVID-19 are unvaccinated.
“Keep in mind, no vaccine is 100% effective,” Choucair said. “So, while we do see some breakthrough cases, the overwhelming majority of those breakthrough cases for people who are fully vaccinated are asymptomatic or mild and people are not having to end up in the hospital or dying from COVID.”
The FDA process ensures the safety, the effectiveness and the quality of production of the vaccine, he said. The review includes looking over pre-clinical data, clinical data and information, inspecting the manufacturing site and more.
“The FDA worked around the clock and has already said that this one of its top priorities,” he said. “We have no doubt that the FDA is the gold standard for safety in the world and people in this country can be confident that this vaccine has met this high level of standards and is safe and effective.”
According to Choucair, the companies behind the Moderna and the Johnson and Johnson vaccines are still collecting data before they submit their application. He added that Pfizer is collecting additional data before seeking the approval of the vaccine for individuals ages 12 to 15.
Dr. Cameron Webb is the senior policy advisor for equity on White House COVID-19 response team. Webb noted that some employers were waiting for the FDA approval in order to require vaccinations.
The announcement follows last week’s news regarding the COVID-19 booster shot rollout plan which is set to begin in September. Eight months after receiving their second dose of the Pfizer or Moderna vaccine, individuals can receive a booster shot.
However, the Centers for Disease Control and Prevention is recommending that individuals who are considered immunocompromised can receive a third dose without waiting eight months.
“We were talking about folks with compromised immune systems, and how for them, they may have never mounted an appropriate response,” Webb said. “Their body may have never created the antibodies necessary to fight COVID…we recommended a third dose of the vaccine for those individuals because that will help get their antibodies to the level where they need to be.”
Boosters on the other hand are for those whose immunity is waning, Webb explained.
Overall, he said, when it comes to vaccination rates there’s still room to go. It’s about meeting people where they are, Webb said, and acknowledging the dynamics that currently exist. Everybody remains a priority, he said.
“I think things like the FDA’s full approval of the vaccine, goes a long way,” Webb said. “These vaccines are safe, and they are effective and that’s by the strictest scrutiny. There’s no country that has a process like the FDA in terms of standard for safety for medications.”
In addition to the vaccine, many people are choosing to mask up again. The Delta variant spreads faster than the Alpha, he said, and nothing should be left to chance.
“Using every tool, we have available to us, it’s not just good science, it’s good public policy,” he said. “People are trying to protect themselves, protect their families and protect their communities not just to survive this pandemic but to get us back to achieving and thriving.”