PERTH, Australia – With the first COVID-19 vaccine ready to be launched in Australia, the Therapeutic Goods Administration has released guidance on its pharmacovigilance plan to track real-world safety data and adverse events following immunization.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C).
HONG KONG – Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, received conditional approval for use by the general public from China’s National Medical Productions Administration (NMPA), two days after filing for conditional market authorization.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective.
Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision.
HONG KONG – China National Biotec Group (CNBG) said that BBIBP-CorV, one of the two COVID-19 vaccines it currently has under development, provides 79.34% protection against the coronavirus.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII).
Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.
PERTH, Australia – The University of Queensland (UQ) and CSL Ltd. are abandoning their trials of an Australian COVID-19 vaccine after recipients generated HIV antibodies during phase I trials. The response means the antibodies produced by the vaccine can interfere with HIV diagnostic tests. However, there was no possibility the vaccine caused infection, and routine follow-up tests confirmed no HIV virus was present, the partners said.