by Linda Straker
- Last week Grenada Pfizer vaccines from US government through COVAX facility
- FDA approved Comirnaty (Covid-19 Vaccine, mRNA) on 23 August
- Comirnaty indicated to prevent Covid-19 in individuals 16 years of age and older
Health Minister Nickolas Steele is hoping that the decision by the US Food and Drug Administration (FDA) to approve the Pfizer-BioNTech vaccine for Covid-19, will bring more confidence to the people, and in turn, lead to an uptake in the vaccine locally.
The FDA has approved Comirnaty (Covid-19 Vaccine, mRNA), which was previously known as Pfizer-BioNTech Covid-19 Vaccine, for the prevention of Covid-19 disease in individuals 16 years of age and older.
“We look forward to others being fully approved so that we can use this and upcoming approvals to help us as stronger tools in our vaccination programme. It’s my hope that it brings more confidence to people,” Steele said. The approval was granted on Monday, 23 August 2021.
Last week Grenada received a shipment of Pfizer vaccines from the US government through the COVAX facility. These vaccines are donated to Grenada by the US Government as part of the Biden-Harris Administration’s global vaccine sharing framework. As of 23 August, nationals have the option of choosing the AstraZeneca or the Pfizer vaccine as protection against Covid-19. “This news is very timely, coming on the same day that we started to offer it as another option,” Steele said.
According to the letter of approval from the FDA, the trading name for the vaccine will be Comirnaty and it will be a vaccine indicated for active immunisation to prevent coronavirus disease 2019 (Covid-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
According to the licensing terms of the Biologics License, the FDA said that it is issuing Department of Health and Human Services US Licence No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products.
“The licence authorises you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards. Under this licence, you are authorised to manufacture the product, Covid-19 Vaccine, mRNA, which is indicated for active immunisation to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older,” said the letter of approval which is addressed to Amit Patel of BioNTech Manufacturing GmbH.
The approval letter also mandates that the company must submit adverse experience reports in accordance with the adverse experience reporting requirements for licenced biological products and it must submit distribution reports at monthly intervals.