FDA Approves New COVID Boosters to Combat New Variants

The FDA authorised the use of COVID-19 vaccines developed by Pfizer/BioNTech and Moderna for emergency purposes on Wednesday.

The organisation highlighted research to back up the safety and effectiveness of this new generation of mRNA vaccinations aimed targeting problematic variations.

If you’ve been waiting for a booster shot specialised to a certain variation, you might be in luck as soon as next week.

The Pfizer EUA is the same as the business’s combo booster injection, which also contains the first COVID-19 vaccine and a shot to defend against the most current Omicron strains, BA.4 and BA.5.

Both the company’s original COVID-19 vaccine and a vaccine designed to protect exclusively against Omicron BA.4 and BA.5 subvariants are included in the Moderna combo vaccination.

According to CDC data, BA.4 and BA.4.6 made up around 11% of the circulating variations as of August 27 while BA.5 made up nearly all of the remaining 89%.

The Advisory Committee on Immunization Practices of the CDC is scheduled to meet on Thursday and Friday to assess the scientific information as the next step. Rochelle Walensky, MD, the agency director, must approve the CDC’s recommendations for usage before the new vaccines may be distributed.

Peter Marks, MD, director of the FDA Center for Biologics Evaluation and Research, said during a televised FDA news conference that “now is the time to consider receiving a booster dose if you haven’t yet received one or it’s been a while since your last booster dose.”

Also, if you haven’t vaccinated your kids, now is a perfect opportunity to think about bringing them along to get their shots, he added.

FDA Commissioner Robert M. Califf, MD, stated that COVID-19 “unfortunately continues to inflict terrible repercussions around the country with approximately 400 deaths and over 5,000 additional hospitalizations every day.” And just recently, preliminary CDC statistics showed that US life expectancy decreased once more in 2021, largely as a result of COVID fatalities.

He continued, “Unfortunately, only approximately half of eligible Americans have received their first booster.” “So, this is a wonderful chance to extend our life expectancy.”

According to CDC data, persons who have received all of their recommended vaccinations are 13 times less likely to die from COVID than those who have not and are three times less likely to die from COVID than those who have only received one booster shot rather than two.

According to Califf, “it’s really sad to see people dying needlessly when there’s a free medication that would prevent their death,” adding that the COVID-19 vaccines’ link to death prevention is “far more apparent than anything I’ve ever seen.”

Present-day and future protection

According to scientific modelling, Marks added, “we are looking at a probable fall wave with a peak around December 1.” “By delivering the boost now, we will hopefully be able to address this possible wave that looms in the future as well as regulate the current plateau that we’re in—we’re sliding off very slowly.”

A potential long-term benefit of the new immunizations, according to Califf, is protection against extended COVID, “which for young people is increasingly a big issue.”

I want to be clear that we have a chance to beat the next wave of COVID-19 thanks to these improved boosters, Califf stated. And in case anyone is interested, the CDC advises getting a COVID-19 booster at the same time as your annual flu shot.

According to Marks, the FDA will keep researching how well the new vaccines defend against COVID in the future.

Additionally, Marks expressed the hope that the vaccines of the future generation would offer greater protection.

The goal, he explained, “is not simply to boost antibodies today, but also to potentially offer us a longer length of protection.”

If this is accurate, Americans may no longer require as many booster shots in the future.

“I hope [this] holds us for as much of the season as possible.”

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