MOSCOW (Pakistan Point News / Sputnik - 21st March, 2021) Australia's Therapeutic Goods Administration (TGA) said Sunday it had approved local production of the COVID-19 vaccine AstraZeneca.
The AstraZeneca vaccine, developed by British-Swedish multinational pharmaceutical and biotechnology company of the same name, was recently suspended in some EU countries after reports of blood clotting in people who had received the jab. AstraZeneca reaffirmed the safety of their vaccine in a press release on March 14. Several days later, the European Medicines Agency and a World Health Organization expert panel announced, separately, that the benefits of the vaccine outweighed associated risks. The vaccination resumed in the EU.
"Earlier today, the Therapeutic Goods Administration approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia," the TGA, which is administered by Australia's Department of health, said in a press release.
The TGA authorized overseas-manufactured Astrazeneca in February.
"Specific approval of Australian manufacturing by TGA was required to ensure that the locally-manufactured vaccine had exactly the same composition and performance as overseas-manufactured vaccine, was made to the same quality and is free of contaminants," the TGA explained.
The vaccine will be manufactured at two sites in suburban Melbourne and is an "exciting milestone in Australia's response to the COVID-19 pandemic," the agency said.
The local production will begin with a TGA batch release, required for every single batch of any vaccine that is supplied in Australia. This will include the review of all documentation on how the vaccine batch was produced, tested, shipped and stored. The review will also look at results of TGA's in-house testing to ensure the vaccine was produced in accordance with all required standards.
Over 1,000 general practices will join Australia's COVID-19 vaccination program starting Monday as they have already been supplied with imported AstraZeneca vaccines. By the end of April, the clinics will increase in number to over 4,000.
