Jun 9, 2021 | News, Regulatory
A new pneumococcal 20-valent conjugate vaccine by Pfizer, PREVNAR 20™, has been approved for adults by the FDA in efforts to strengthen the prevention of disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes. The authorized vaccine not...
Jun 2, 2021 | News, Regulatory
Israel’s Ministry of Health has found a possible link between myocarditis (heart inflammation) in males aged 16-30 and the second Pfizer vaccine. In examining the matter, the Ministry has disclosed the findings of its commissioned study stating that among the total 5...
May 11, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine to now include young teens between 12 and 15 years of age. Previously, the EUA was approved for patients 16 years of age and older,...
Feb 10, 2021 | News, Regulatory
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
Dec 14, 2020 | News, Regulatory
Pfizer and BioNTech have made history with their COVID-19 vaccine, as it is the first to enter the U.S. market after Phase 3 clinical trial results showing 95% efficacy. The mRNA vaccine is being allocated for emergency use to hospitals nationwide,...
