Going forward with an Emergency Use Authorization (EUA), the Food and Drug Administration (FDA) has permitted the use of Pfizer-BioNTech’s COVID-19 vaccine for adolescents aged 12-15 years. The Phase 3 trial for this vaccine reportedly demonstrated 100% efficacy in this age group.
The vaccine had already been approved for individuals aged 16 and above in the US, and according to a study in Israel, has proven an on-ground efficacy of 95% against coronavirus.
“The study found that two doses conveyed 95.3 percent protection against infection and 96.7 protection against death seven days after the second dose. After 14 days, that protection increased to 96.5 percent and 98 percent, respectively,” Firstpost reported. Over 70% of Israel’s population has been fully vaccinated with Pfizer, making this the largest real-world study of the vaccine.
Pfizer Inc. released a statement on Twitter stating, “colleagues at distribution centers in the U.S., Europe, and Asia are hard at work rushing shipments of Pfizer medicines that the Government of India has identified as part of their COVID treatment protocol.” Pfizer Chairman and CEO Albert Bourla in his open letter has acknowledged the deficit and urgency of vaccinations and has assured efficient delivery of doses all over the world. He has also detailed the company’s plan in effectively overcoming distribution, storage, and tracking problems.
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Pfizer’s possible extension of the vaccine to India’s inoculation program has been in the works since April. “Unfortunately, our vaccine is not registered in India, though our application was submitted months ago. We are currently discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country”, said CEO Bourla in a video statement on May 3.
India has fully vaccinated less than 3% of the total population. According to the latest vaccination rules in India, COVID-19 vaccines already approved by the FDA, and other internationally recognized authorities or those listed for emergency use by the World Health Organization (WHO) will be approved immediately, pending clinical trials within 30 days of authorization.