FDA Wants Anti-COVID-19 Variant Boosters Out Quickly

An FDA ruling this week quickens the process by which COVID-19 vaccine manufacturers can get to the market—and into arms—booster shots that are targeted at variants.

New cases of coronavirus disease 2019 (COVID-19) infection, hospitalization, and death continue to plummet across the United States. Yesterday, there were 56,044 new cases of COVID-19, while 1415 people died from the disease, according to Johns Hopkins University. At the height of the recent surge, some days saw over 4000 deaths.

Some news on the COVID variants front as well. Health care experts have been telling Infection Control Today® that the vaccines are somewhat effective against the variants, but that they could be re-engineered as booster shots that would hopefully be very effective against the variants.

And those booster shots would arrive in a hurry, thanks to a ruling this week by the Food and Drug Administration (FDA). The FDA on Monday said that the makers of vaccines, treatments, and tests do not have to conduct large, time-consuming clinical trials to move those products to the frontlines.

Acting FDA Commissioner Janet Woodcock, MD, said in a statement that “we know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

There is a precedent for this. The annual flu vaccines only need to show efficacy in small clinical trials. Two manufacturers of COVID-19 vaccines—Moderna and Pfizer-BioNTech—are busy modifying their vaccines so that they will be more effective against the variants.

As more and more people get fully vaccinated—that is, get the two doses—what does that mean for them, exactly? Will they still have to social distance? How about wearing a mask? If a fully vaccinated person comes into contact with someone who has COVID-19, does the fully vaccinated person then have to quarantine? The questions boil down to this: How should we live our lives now? The Centers for Disease Control and Prevention (CDC) might be providing answers to those questions soon.

There are some dark clouds to watch besides the COVID variants. Children’s hospitals in America say that they are seeing a surge in cases of an illness that follows infection from COVID-19. It’s called multisystem inflammatory syndrome and symptoms include stomach pain, vomiting, diarrhea and fever. It affects youngsters between 1 and 14 years old, and disproportionately affects children of color. As reported by Axios today, hospital officials say that the illness seems to be more common than it was earlier in the pandemic. Between October 1, 2020 and January 7, 2021, COVID hospitalizations for adults exploded by almost 300%, according to researchers at the University of Minnesota. During that same period, pediatric COVID-19 hospitalizations rose 50%. Since January 7, adult hospitalizations fell by 54%. Hospitalizations for children fell by 25%.

Meanwhile, since the pandemic began, there have been over 28 million confirmed cases on COVID-19, in the US, while over 500,000 people have died from the disease. In the world, there have been about 112 million confirmed cases of COVID-19, while about 2.5 million people have died from the disease.