Clinical Covid-19 booster shot roll out plan expected to be...

Covid-19 booster shot roll out plan expected to be finalized by FDA by end of Q3


The U.S. Food and Drug Administration (FDA), in a discussion, proposed an early September timeline for rolling out a strategy for COVID-19 vaccine booster shots, as told by Biden administration.

The strategy would be applicable to all vaccinated people. However, the official said that the decision for the people with weak immune system is likely to be taken shortly.

The booster shot for COVID-19 vaccinated people is yet not recommended in the United States. Nevertheless, if it is recommended, U.S. will have its supply, personnel and also the capacity to efficiently launch it, the officials said.

FDA is working out the solutions regarding uncertainties in the use of COVID-19 vaccine booster doses, together with NIH and CDC, FDA spokeswoman told CNN. 

The spokesperson, Abby Capobianco, said in a statement, “The agencies are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”

The decision to lay out a plan for booster shots is taken as the country continues to suffer with the surge in COVID cases and hospitalizations, due to the highly contagious Delta variant, largely among unvaccinated people. 

In getting eligible American population vaccinated against COVID-19, Biden administration has played a significant role. The percentage of fully vaccinated people, out of the ones eligible for vaccination, has reached up to 49.9% as of Thursday, 5th of August, 2021.

According to the data provided by U.S. Centers for Disease Control and Prevention (CDC), the daily pace of vaccinations is the highest in past seven weeks.

Despite the World Health Organization’s call for moratorium on booster shots till end of September at least ̶  so that 10% of every country’s population gets vaccinated ̶  few countries including France, Germany, Israel and the U.K. are already proceeding with the plan to administer COVID-19 vaccine booster shots starting September or even before. 

People with compromised immune system may be needing supplementary protection even after receiving COVID-19 vaccine, said Dr. Anthony Fauci, the head of the National Institutes for Allergies and Infectious Diseases. A lot of effort has been put in making vaccine boosters available to such people “very soon”, he said.

Vaccine advisers to the CDC have held a discussion in this matter, however, they have neither given any formal recommendation regarding giving booster shots to immunocompromised ones, nor have voted for guidance yet.

“We are trying very hard to get the regulatory mechanism in place very soon to get those individuals a boost that might bring up their immunity to the level where it should be, if possible,” said Fauci.  

COVID-19 vaccine booster by Moderna showed 93% efficacy and resilience through six months against the disease, whereas, Pfizer/BioNTech demonstrated overall six-month efficacy of 91%. Nevertheless, the follow-up data collected for both the vaccines is not recorded after a surge is being noticed in cases due to Delta variant of the virus.  

In Moderna’s view, the Delta variant can bring more advanced infections, so the vaccine boosters will be needed before winters.

Pfizer is all set to submit its booster for the emergency use authorization (EUA) consideration by this month.

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