Who were equally allocated to the vaccine or a placebo. What benefits of BNT162b2 have been shown in studies?īNT162b2 has been studied in approximately 43,000 individuals 16 years of age and older If a person has any questions concerning the vaccine, they should ask the administering This vaccine can only be obtained with a prescription.
Healthcare Professionals and the Information for UK recipients available on the Medicines and Healthcare products Regulatory Agency ( MHRA) website. You should receive two doses (eachįor further information on how BNT162b2 is used, refer to the Information for UK Muscle at the top of the upper arm (deltoid muscle).
Following dilution with saline,īNT162b2 is given to you by an authorised practitioner as an intramuscular injection into the The pharmaceutical form of this medicine is an injection. Stimulates immune cells to protect against COVID-19. When a person is given BNT162b2, it triggers the body to naturally produce antibodies and What is BNT162b2 and what is it used for?īNT162b2 is a vaccine indicated for active immunisation to prevent COVID-19 caused by the SARS-CoV-2 virus, in individuals 12 years of age and older. The product will be referred to as BNT162b2 in this lay summary for ease of reading.įor practical information about using BNT162b2 patients should read the Information for UK recipients or contact their doctor or healthcare practitioner.
Provide practical advice on how to use this product. Of the Human Medicine Regulations, as well as its conditions of use. It explains how this product was assessed and authorised under Regulation 174 This is a summary of the Public Assessment Report ( PAR) for COVID-19 mRNA VaccineīNT162b2.
The Committee of Ministers also has adopted a resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies as the US FDA looks to crack down on such compounding pharmacies, which produced drugs that led to numerous deaths in the US.Authorisation for Temporary Supply, COVID-19 mRNA Vaccine BNT162b2 (BNT162b2 RNA) concentrate for solution for injectionĭepartment of Health and Social Care ( DHSC), Pfizer Limited & BioNTech Manufacturing, GmbH Lay summary, COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection (BNT162b2 RNA) In addition to the South Africa announcement, the EDQM (European Directorate for the Quality of Medicines & HealthCare), which supports the EU Pharmacopeia, announced Monday that it would craft a draft resolution aiming to harmonize the quality and safety standards around the production of pharmaceuticals in pharmacies.įollowing a survey in 2008 by the Committee of Experts on Quality and Safety Standards for Pharmaceutical Practices and Pharmaceutical Care, the EDQM found “a wide gap” in quality assurance and standards for pharmacy-made medicinal products between EU countries, as well as a gap in quality assurance between preparation in pharmacies and medicines prepared by the pharmaceutical industry. The standards are official for all 37 member states and the EU. The eighth edition of the European Pharmacopeia includes more than 2220 monographs and 340 general chapters on the specifications for active substances and excipients used in medicines. The council, unlike a number of regulators in neighboring African countries, has made a push in recent years towards more transparency by seeking industry comment on new regulations and guidance, as well as keeping its website up to date.Īlthough observer states to the European Pharmacopeia are not required to institute the monographs or chapters, some, such as Canada and Australia, have done so in the past. The Medicines Control Council of South Africa - which joins Morrocco, Tunisia, Guinea, Senegal and Algeria among its African counterparts, and 20 other observers, including the World Health Organization – will now be able to attend the pharmacopeia commission’s sessions.