Aug. 31, 2021 -- An independent expert panel of the CDC has studied the potential benefits and risks of the Pfizer COVID-19 vaccine and voted unanimously to recommend the shots for all Americans ages 16 and older.
The inoculation is still available to teens ages 12 to 15 under the FDA’s emergency use authorization.
CDC Director Rochelle Walensky, MD, signed off on the recommendation later Monday. .
After reviewing the evidence behind the vaccine, panel member Sarah Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia, said she couldn't recall another instance where panelists had so much data on which to base their recommendation.
"This vaccine is worthy of the trust of the American people," she said.
Doctors across the country use vaccines in line with the recommendations made by the ACIP. Their approval typically means that private and government insurers will cover the cost of the shots. In the case of the COVID-19 vaccines, the government is already picking up the tab.
The panel's independent review of the vaccine's effectiveness from nine studies held few surprises.
They found the Pfizer vaccine prevented a COVID infection with symptoms about 90%–92% of the time, at least for the first 4 months after the second shot. Protection against hospitalization and death was even higher.
The vaccine was about 89% effective at preventing a COVID infection without symptoms, according to a pooled estimate of five studies.
The data included in the review was only updated through March 13 of this year, however, and does not reflect the impact of further waning of immunity or the impact of the Delta variant.
In making their recommendation, the panel got an update on the safety of the vaccines, which have now been used in the US for about 9 months.
The rate of serious allergic reactions, called anaphylaxis, has settled at around 5 cases for every 1 million shots given, according to the ACIP's review of the evidence.
Cases of myocarditis and pericarditis, serious inflammation of the heart after vaccination, were more common after getting a Pfizer vaccine than would be expected to happen naturally in the general population, but the risk was still very rare, and elevated primarily for men younger than age 30.
Out of 17 million second doses of Pfize vaccines given in the US, there have been 327 confirmed cases of myocarditis reported to the Vaccine Adverse Event Reporting System in people who are younger than age 30. The average hospital stay for a myocarditis cases is 1 to 2 days.
So far, no one in the U.S. diagnosed with myocarditis after vaccination has died.
What's more, the risk of myocarditis after vaccination was dwarfed by the risk of myocarditis after a COVID infection. The risk of myocarditis after a COVID infection was 6 to 34 times higher than the risk after receiving an mRNA vaccine.
About 11% of people who get the vaccine experience a serious reaction to the shot, compared with about 3% in the placebo group. Serious reactions were defined as pain; swelling or redness at the injection site that interferes with activity; needing to visit the hospital or ER for pain; tissue necrosis, or having skin slough off; high fever; vomiting that requires hydration; persistent diarrhea; severe headache; or muscle pain/severe joint pain.
"Safe and Effective"
After hearing a presentation on the state of the pandemic in the US, some panel members were struck and shaken that 38% of Americans who are eligible are still not fully vaccinated.
Pablo Sanchez, MD, a pediatrician at Nationwide Children's Hospital in Columbus, OH, said, "We're doing an abysmal job vaccinating the American people. The message has to go out that the vaccines are safe and effective."