Earlier today the US Food and Drug Administration (FDA) granted the mRNA COVID-19 vaccine made by Pfizer-BioNTech full approval, a milestone in the ongoing pandemic.
Though the vaccine has been used under an emergency use authorization (EUA) since last December, a full approval allows more businesses, schools, and organizations to mandate vaccine use among employees and students, and offers legitimacy to a vaccine some people believe has been rushed through safety evaluations and protocols.
"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," said Acting FDA Commissioner Janet Woodcock, MD, in a press statement.
"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."
Pfizer's vaccine, which is administered in two doses 3 weeks apart, will still be under an EUA for recipients ages 12 to 15, and for immunocompromised individuals who qualify for a third dose of the vaccine 28 days after their second dose.
The FDA said it reviewed hundreds of pages of clinical study results and drug trial documentation before the approval, including details of a trial of 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The FDA said 12,000 vaccine recipients have been followed-up for at least 6 months.
Pentagon, NYC schools announce vaccine mandates
Following the announcement, the Pentagon said it was moving to make the vaccine mandatory for all 1.4 million active duty troops, and several major universities and school districts announced vaccine mandates, as well.
In New York City, Mayor Bill de Blasio said all 148,000 public school teachers and staff will be required to be vaccinated with at least one dose by Sep 27. Before FDA approval, the mayor said either vaccination or weekly testing was required for school staff.
While FDA approval makes mandates easier, it also makes it legal to give the vaccine off-label. Today the American Academy of Pediatrics (AAP) called for a completion of clinical trials of the vaccine in children ages 6 months and up before use in young children.
"The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children," said AAP President Lee Savio Beers, MD, FAAP in a statement. "The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA."
The AAP still recommends the vaccine be used in all children 12 and up.
Florida cases top 3 million
Florida has joined Texas and California as the third state in the country to breach 3 million COVID-19 cases, as a summer surged field by the Delta (B1617.2) variant continues to cause a spike in activity in the state.
The state reported a new high in COVID-19 deaths, with 1,486 in the past week, nearly 15% above the previous record. According to USA Today, Orlando's largest healthcare system reported 1,620 patients currently hospitalized, twice as many as last winter's peak.
The United States reported 36,692 new COVID-19 cases yesterday and 200 deaths, according to the Johns Hopkins COVID-19 tracker.
The 7-day average of new daily cases is 140,264, according to the Washington Post tracker. New daily cases rose 7.7% in the past week, while hospitalizations climbed 10.0% and deaths skrocketed by 47.2%.
As states battle increasing cases, demand for antibody treatments has also increased, especially in Texas, Florida, and Louisiana, according to the Associated Press. White House officials reported recently that federal shipments of the drugs increased fivefold last month, to nearly 110,000 doses.
The treatment, most commonly Regeneron's dual-antibody cocktail, is used in people with mild to moderate symptoms who are not hospitalized but are at risk for serious disease.
In related news, the FDA issued a warning over the weekend against the use of ivermectin to treat or prevent COVID-19. The drug prevents parasites in farm animals, but some people have experimented with taking the drug to prevent the coronavirus.
Late last week, Mississippi's health department issued an alert saying its poison control center is receiving calls from people experiencing symptoms after ingesting livestock ivermectin.
"Animal drugs are highly concentrated for large animals and can be highly toxic in humans," the health department warned. "Some of the symptoms associated with ivermectin toxicity include rash, nausea, vomiting, abdominal pain, neurologic disorders, and potentially severe hepatitis requiring hospitalization."
Other US developments
- A national poll from the University of Michigan today highlighting families' worries over sending kids back to school during the pandemic shows 26% of students fear having to complete virtual learning again, Three in five parents surveyed said their child would feel safer if most students and teachers were vaccinated against COVID-19.
- The Centers for Disease Control and Prevention said on Friday that people who are at increased risk for severe illness from the coronavirus should avoid traveling on cruises, according to Axios.
- Hospitals in the South and Midwest say they are treating more children with COVID-19 than ever and are preparing for worse surges to come, the Wall Street Journal reported yesterday.
