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April 12, 2021

Coronavirus company news summary – Pfizer/BioNTech seek FDA approval for Covid-19 vaccine in adolescents – EMA investigates J&J single-dose vaccine for potential blood clot link

By Chris Lo

Pfizer and BioNTech are seeking US Food and Drug Administration (FDA) approval to expand the emergency use authorisation (EUA) for their Covid-19 vaccine to children aged between 12 and 15 years. The request comes immediately after Pfizer released data showing its vaccine to be 100% effective and well tolerated by the younger group. The findings also indicated that children had stronger immune responses than adults one month after the second dose.

After AstraZeneca’s Covid-19 vaccine made headlines due to a potential link to rare blood clots, European drug safety regulators are now investigating the possible clotting risks from Johnson  & Johnson’s single-dose Covid-19 vaccine. According to the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee, four cases of unusual blood clots with low blood platelets following Covid-19 Vaccine Janssen have been reported in the US rollout. The vaccine is currently in use only in the US, under an emergency use authorisation.

According to real-world data from Israel, the South Africa coronavirus variant may evade the protection offered by the Pfizer-BioNTech Covid-19 vaccine. The study compared nearly 400 individuals infected with the SARS-CoV-2 virus, 14 days or more after receiving one or two doses of the vaccine, against the same number of unvaccinated patients with the disease. The study revealed that the B.1.351 variant made up 1% of all the Covid-19 cases across all the people studied, while those who had received two doses of the vaccine, the variant’s prevalence rate was eight times higher than those unvaccinated. The study has not been peer-reviewed.

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