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Health Minister welcomes Pfizer-BioNTech vaccine FDA approval

This story was posted 9 months ago
23 August 2021
in Health
2 min. read
Hon. Nickolas Steele
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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 licencing terms of the Biologics Licence, 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.

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Tags: comirnatycoronaviruscovid-19linda strakernickolas steelepfizer-biontechsevere acute respiratory syndrome coronavirus
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Comments 3

  1. James S says:
    9 months ago

    As a careful observer of 28 years of biological warfare in the USA. I would expect nothing less from the Federal Death Administration.

    Reply
    • anthony slaine says:
      9 months ago

      You would say that you anti vaxxer. Pfizer is the first Covid vaccine to be approved by the FDA therefore you can no longer keep lying about it being an “experimental” vaccine, which it has not been since it was released as an emergency (not experimental) vaccine along with Astra Zeneca, Johnson & Johnson etc.

      Reply
      • James S says:
        9 months ago

        You talk as though being against injecting,
        formaldehyde
        aluminum hydroxide
        aluminum phosphate
        thimerosal (mercury)
        polysorbate 80
        neomycin
        hydrolized gelatin
        chick embryo
        human diploid cells from aborted fetal tissue
        benzethonium chloride
        monkey kidney cells
        SV-40 (Simian virus)
        bovine gelatin and serum
        chicken protein
        aspartame
        polymyxin
        beta-propiolactone
        mouse serum proteins
        engineered prion-related spike proteins
        monosodium glutamate
        squalene
        graphene
        (all toxic, potentially cancer causing, or immune disregulating),

        is a bad thing. By the way, why does an “approved” vaccine need additional studies until 2025? Did you even read the attached letter? Who funds the FDA? I’ll give you a free one. The FDA is 75% industry funded. Talk about the fox guarding the hen house. Maybe you are friends with the fox?, or maybe you are just a die hard virtue theorist who thinks our pharma funded, un-elected “governing health authorities” are on their way to Sainthood – as pure as the newly fallen snow.

        Reply

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