FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates
Jacqueline Howard By Jacqueline Howard, CNN 7 minute read Updated 12:25 PM EDT, Mon August 23, 2021
CNN — The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
The vaccine will be marketed as Comirnaty, the FDA said in its announcement on Monday. The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older, and in May, the authorization was extended to those 12 and older.
“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” according to the FDA.
Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.
“While this and other vaccines have met the FDA’s rigorous scientific standards for emergency use authorization, as the first FDA approved Covid-19 vaccine, the public can be confident that this vaccine meets the FDA’s gold standard for safety, effectiveness and manufacturing quality that we require for an approved product,” FDA Acting Commissioner Dr. Janet Woodcock said during a briefing on Monday, calling the approval “a pivotal moment” for the United States’ fight against the coronavirus pandemic.
“Health care providers can continue to use the vaccine on their shelves,” Woodcock added. “The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably to provide the Covid-19 vaccine series.”
Agency official said Monday they hope approval will push unvaccinated people to get vaccinated. US Surgeon General Dr. Vivek Murthy said on CNN’s State of the Union on Sunday that approval could encourage individuals to act, and more mandates.
“For businesses and universities that have been thinking about putting vaccine requirements in place in order to create safer spaces for people to work and learn, I think that this move from the FDA, when it comes, will actually help them to move forward with those kinds of plans,” Murthy told CNN’s Brianna Keilar.
Murthy also noted “a small number of people” have been waiting for full approval before getting their shot and believes “this may tip them over toward getting vaccinated.”
Why emergency use authorization came first Due to the seriousness of the pandemic, vaccine makers originally applied for emergency use authorizations because the authorization process takes less time than what’s required for full approval.
In July, drugmaker Pfizer announced that the FDA granted its vaccine a priority review, and the FDA had been pulling in extra help from across the agency to speed final approval of the vaccine.
The FDA worked around the clock and conducted its own analyses of the vaccine in addition to the companies’ analyses, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during Monday’s briefing.
“We also did benefit-risk assessments based on real-world data that has emerged since the vaccine has now been used in hundreds of millions of people globally. And so that actually takes a lot of work,” Marks said, adding that the agency also inspected facilities that make the product.
Respectfully addressing the misinformation about COVID-19 vaccines:
While I appreciate your focus on factual accuracy, some of the statements in your post contain inaccuracies and potential misinformation. I'd like to clarify those points while respecting your right to share your perspective.
Here's a breakdown of the points to address:
1) COVID-19 vaccines not approved? This is partially true. While some age groups and specific doses still fall under Emergency Use Authorization (EUA), two COVID-19 vaccines: Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) have received full regulatory approval for individuals 16 and 18 years old and older, respectively.
Full Regulatory Approval (BLA): Pfizer-BioNTech (Comirnaty): Approved for individuals 16 years and older on August 25, 2021. Moderna (Spikevax): Approved for individuals 18 years and older on January 31, 2022.
2) Child Vaccine Act shielding manufacturers? While the Child Vaccine Act of 1986 provides limited liability protection for vaccine manufacturers in specific cases, it does not imply a lack of safety testing or approval processes. Additionally, the EUA process also involves rigorous safety and efficacy evaluation.
3 Deleterious effects surfacing over time? Claims of significant long-term negative effects from COVID-19 vaccines lack credible evidence. Extensive surveillance and research continue to monitor vaccine safety, and no widespread, serious long-term side effects have been established. Individual reactions to vaccines can vary, but these are typically mild and short-lived.
I don't know about you, but when I get my COVID vaccine I am given a site to register with the FDA, and they texted me regularly on multiple vaccinations to check on side-effects and any health issues. I had not issues from the vaccines beyond the normal, expected, initial vaccine's making me a bit tired. Subsequent boosters had little impact even right after the vaccinations, which I typically have scheduled with my flu vaccine.
4) Public and private data proving vaccines a failure? This statement requires careful analysis of the sources and interpretation of such data. While vaccines, like any medical intervention, may not be 100% effective in preventing all infections, they have demonstrably reduced COVID-19 hospitalization, severe illness, and death.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
