• Andrea Vidican

Updates to the safety and security of the Pfizer vaccine according to the FDA

As of late September, Pfizer-BioNTech announced the results of their Covid-19 vaccine trials for children from 5 to 11 years of age, which have proved to be effective in protecting them from the virus without many cases of dangerous side effects. As a result, Pfizer is likely to gain full approval from the Food and Drug Administration soon this Autumn since “The data came a little earlier than some were expecting and depending on how long the FDA takes to review the application, whether it's a four-week review or a six-week review, you could have a vaccine available to children as early as probably by the end of October, perhaps it slips a little bit into November" if they pass the rigid requirements and monitoring of the vaccine.
In the description of their trials, the pharmaceutical company administered 2 doses of 10 micrograms of the vaccine 21 days apart for children 5 to 11 years of age. The side effects of the vaccine were similar to those of the vaccinated individuals who were older. The only noteworthy difference in the official regimen was that Pfizer had only used a third of the dosage for the younger children as opposed to the 30 microgram dose for those over 11 years old. The decision for this factor was stated in their press release: “The 10 µg dose was carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children 5 to 11 years of age.” as younger children have more sensitive immune systems. However, this doesn’t alter the effectiveness of the vaccine in this particular age group as Dr. Ugur Sahin, CEO, and co-founder of BioNTech affirmed “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
Pfizer-BioNTech’s public release of their vaccine trials for younger children came as pediatric cases of Covid-19 are increasing with many schools returning to in-person learning. The knowledge of the rise in cases has been provided by Albert Bourla, Chairman and Chief Executive Officer of the company, who mentions “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” also expressing, “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”
Despite the trials’ favorable results, it may take a while for official vaccine mandates to be implemented for children in this age group. Perhaps once the company has proven the safety and effectiveness of their vaccine for all individuals, current Covid-19 vaccine policies may be altered for the future.

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