COVID-19 Round-Up: FDA Approves Pfizer/BioNTech Vaccine; Pandemic Linked to Prescription Drug Misuse in Adolescents; and More

Moderna Submits its COVID-19 for FDA Approval

This week, Moderna announced it completed its submission to the US Food and Drug Administration (FDA) for full approval its COVID-19 vaccine for individuals 18 years and older. The company said it has requested FDA priority review. Moderna had started submitting data for its Biologics License Application (BLA) to the FDA back in June. “This BLA submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” Moderna CEO Stéphane Bancel said in a statement, as reported by CNN.

Pfizer/BioNTech Seeks Booster Shot Approval

Pfizer/BioNTech intends to complete submission for approval for their supplemental Biologics License Application for a third dose of their COVID-19 vaccine. In a press release, the companies described a successful trial consisting of 306 people who received booster dose nearly five and eight months subsequent to their second dose. The results showed that the booster generated higher levels of antibodies, and was safe, with only “mild to moderate” side effects, such as fatigue, muscle/joint pain, and chills.

The COVID-19 Pandemic has Increased Nicotine Use and Prescription Drug Abuse in Adolescents

A study finds that during the COVID-19 pandemic, alcohol use has actually decreased among adolescents age 10 to 14, however, the use of nicotine and the misuse of prescription drugs has increased. The findings appeared in the Journal of Adolescent Health. In this particular survey study, researchers assessed 7,842 adolescents and their families at 21 US sites for the first six months during stay-at-home orders in response to the spread of COVID. The results showed that substance use among adolescents was stable during the first six months of the pandemic, and the use of alcohol declined compared to pre-pandemic levels. However, the researchers observed an augmented use of nicotine and misuse of prescription drugs. They postulate this is because the latter are easier to hide from their families during quarantine.

FDA Grants Full Approval of Pfizer COVID Vaccine

The U.S. Food and Drug Administration on Monday granted full approval for Pfizer’s coronavirus vaccine. “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in an agency news release. “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 very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”