The U.S. Food and Drug Administration late Thursday approved an additional COVID-19 syringe for people with compromised immune systems to underscore the risk the virus still poses to some vaccinated Americans.
"The country has entered another wave of the COVID-19 pandemic and the FDA is particularly aware that immunocompromised people are particularly at risk of serious illness," Acting FDA Commissioner Janet Woodcock said in a statement. “After a thorough review of the available data, the FDA determined that this small, vulnerable group could benefit from a third dose of the Pfizer BioNTech or Moderna vaccines.
"Today's action enables doctors to boost immunity in certain immunocompromised individuals who need additional protection from COVID-19. As we mentioned earlier, other people who are fully vaccinated are adequately protected and do not currently need an additional dose of the COVID-19 vaccine, "Woodcock said.
The FDA's announcement was made ahead of the CDC Advisory Committee meeting scheduled for Friday. The committee is expected to decide whether the CDC should recommend additional vaccination for people with immunodeficiency.
This was the first US regulatory approval for any type of COVID-19 booster vaccine. Other countries, including Israel, France and Germany, have announced that they will be giving some members of their population an additional shot.
It comes at a time when awareness of breakthrough infections among vaccinated Americans is growing in an increase in daily cases equal to the numbers seen in early February.
Doctors say the most serious of these breakthrough cases occur in immunocompromised people, including organ transplant patients, people undergoing chemotherapy, Americans taking chronic drugs that can suppress their immune systems, and the elderly.
However, FDA approval does not include the elderly.
"We don't believe that others – elderly or non-elderly who are not immunocompromised – need a vaccine right now, but this is a dynamic process and the data is being evaluated," Dr. Anthony Fauci, senior medical advisor to President Joe Biden, told reporters Thursday.
This is a sharp turn in thinking from a month ago when the CDC and FDA released a joint statement on July 8th stating that fully vaccinated people don't need an extra dose.
The FDA has not confirmed its plan to update the emergency clearances for Pfizer Inc.
and Moderna Inc
COVID-19 vaccines are said to contain booster vaccinations, as reported by multiple media outlets. (Both vaccines are mRNA syringes with similar rates of effectiveness in clinical rates.)
However, the regulator told MarketWatch that "the agency is working with the CDC to evaluate potential options on this issue and will exchange information in the near future."
Breakthrough infections are still considered rare among the more than 167 million Americans fully vaccinated. However, there is anecdotal evidence and some research to show that a small but increasing number of people who are fully immunized get sick or test positive for the virus. Most report mild and moderate infections.
Almost all hospital admissions and deaths currently occurring are unvaccinated; An analysis by the Kaiser Family Foundation on July 30, using somewhat limited data from 16 states, found that breakthrough hospital admissions accounted for 5% or less of hospital admissions and 3% or less of deaths.
The U.S. doesn't by and large track the number of breakthrough infections occurring, and it's known that vaccine-induced immunity may decline in some people, in part because the vaccines we have may offer less protection against the more contagious Delta variant .
Fauci noted during the briefing that at some point boosters will be needed for the general public. "Sooner or later you will need a booster to provide permanent protection," he said.
It's a much more worrying scenario for people who are immunocompromised.
According to George Yancopoulos, president of Regeneron Pharmaceuticals Inc. REGN, in his remarks last week on the company's monoclonal antibody treatment, immunocompromised people likely make up between 3% to 4% of the US population.
He also said that about half of these people fail to develop an immune response after sometimes "three attempts with the vaccine," according to a FactSet transcript of the investor appeal.
However, some early research has shown that an extra dose can boost the immune response in these patients. A third dose of BioNTech BNTX and Pfizer vaccine in solid organ transplant patients "significantly improved the immunogenicity of the vaccine with no reported cases of COVID-19," a group of doctors in France wrote Thursday in the New England Journal of Medicine.
"Many of the immunocompromised patients we've had were actually organ transplant patients who took every possible precaution," said Dr. Nida Qadir, assistant director of the medical intensive care unit at the Ronald Reagan UCLA Medical Center in Los Angeles. “They were vaccinated when they could. And so they are often surprised and also really frustrated because they had the feeling that they had played their part and unfortunately still got sick. "