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Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

EMA's safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).

In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

EMA's human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.

EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events

Several authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca. This is a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine, as previously reported.

EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU

EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age.

After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality.

EMA starts rolling review of the Sputnik V COVID-19 vaccine

EMA's human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine(1) developed by Russia's Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH.

FDA issues Emergency Use Authorization for third COVID-19 vaccine

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Regulatory Affairs News

Joint CDC and FDA statement on Johnson & Johnson COVID-19 vaccine

AstraZeneca's COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets

Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna

EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events

EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU

EMA starts rolling review of the Sputnik V COVID-19 vaccine

FDA issues Emergency Use Authorization for third COVID-19 vaccine

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