COVID-19 Updates: FDA Grants Full Approval for Pfizer Vaccine, Patients Advised Not to Rush for Boosters

African American man in antiviral mask gesturing thumbs up during coronavirus vaccination, approving of covid-19 immunization

At least 212 million cases of COVID-19 have been diagnosed worldwide as of Monday evening, August 23, 2021, including at least 4.44 million deaths. Healthcare officials in the United States have reported at least 37.8 million positive COVID-19 cases and approximately 628,000 deaths. Source: Johns Hopkins University & Medicine

At least 4.97 billion individual doses of COVID-19 vaccine have been administered worldwide as of Monday evening, including at least 363 million in the United States. Source: GitHub

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FDA grants full approval for Pfizer-BioNTech vaccine

The Pfizer-BioNTech COVID-19 vaccine received full approval by the U.S. Food and Drug Administration (FDA) on August 23.

The vaccine will now be marketed as Comirnaty and is available to all individuals aged 16 and older, according to a press release by the FDA. The vaccine also continues to be available under emergency use authorization (EUA) for individuals ages 12-15 years, as well as for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Janet Woodcock, MD, acting FDA commissioner. “While millions of people have already safely received COVID-19 vaccines, we recognize that, for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals aged 16 years and older. The authorization was expanded to include those 12-15 years in May 2021.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety, and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA), a comprehensive document that is submitted to the agency that provides specific requirements.

For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, PhD, MD, director of FDA’s Center for Biologics Evaluation and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.

“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

Although not an FDA requirement, the company has also reportedly committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.

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Patients advised “not to rush” for boosters

Severely immunocompromised people are currently eligible for a third dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines. However, all other patients should be advised that they should only receive a third dose eight months after their second dose.

According to a recent report by ABC, experts are cautioning that patients not receive the booster sooner than the recommended eight-month guideline. Citing William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, patients will “get a more robust immune response” if they follow this protocol.

Although immunity appears to wane over time, it is believed to be a gradual progression, with current data suggesting all authorized vaccines provide good protection at least six months after initial vaccination.

Vivek Murthy, MD, U.S. surgeon general, told ABC that “we are concerned that this pattern of decline we are seeing will continue in the months ahead.” “We don’t have data that suggests you benefit from having the additional dose of the vaccine before your immunity drops off,” added Jay Bhatt, an internist and geriatrician.

Those patients who received the Johnson & Johnson vaccine will also likely need an additional dose, but data is still developing on these guidelines, the report states.

Tweeted message warns against using ivermectin

The U.S. Food and Drug Administration (FDA) took to Twitter recently to warn the public to not take veterinary drugs as a way to treat or prevent COVID-19. According to various reports, the messaging followed several instances of patients being hospitalized after self-medicating with ivermectin, a drug intended for horses.

“You are not a horse. You are not a cow. Seriously, y’all. Stop it,” the FDA’s tweet reads.

Ivermectin, which is not an antiviral drug, is generally used to treat or prevent parasites in animals. Patients who overdose on the drug can experience nausea, vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, problems with balance, seizures, coma, and death, according to the FDA.

Officials have also clarified that FDA-approved ivermectin tablets are meant to treat humans with certain conditions caused by parasitic worms, as well as topical formulations used for head lice and skin conditions such as rosacea. But these products are different from the drug used on animals. No form of ivermectin has been approved for use in treating or preventing COVID-19 in humans.

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