The full public assessment report for BNT162b2 follows this summary. Other information about BNT162b2Īuthorisation for the temporary supply of BNT162b2 was granted in the UK on 1 December Monitoring plan for all COVID-19 vaccines to enable rapid analysis of safety information The MHRA has also put in place an additional proactive safety Based on this plan, safety information has been included in the Information for UK Healthcare Professionals and the Information for UK recipients, including the appropriate precautions to be followed by healthcare professionals and patients.Īll side effects reported by patients/healthcare professionals are continuously monitored.Īny new safety signals identified will be reviewed and, if necessary, appropriate regulatoryĪction will be taken. An RMP has been agreed for the use of BNT162b2 in the UK. What measures are being taken to ensure the safe and effective use of BNT162b2?Īll new medicines approved require a Risk Management Plan ( RMP) to ensure they are used as safely as possible.
Therefore, the MHRA concluded that theīenefits are greater than the risks and recommended that this medicine can be authorised for temporary supply during the COVID-19 pandemic. Furthermore, the side effects observed with use of this vaccine are considered to be similar to those seen with other vaccines. It was concluded that BNT162b2 has been shown to be effective in the prevention ofĬOVID-19. Were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain and fever.Īdverse events were usually mild or moderate in intensity and resolved within a few daysĪfter vaccination. The most common side effects with BNT162b2 (which may affect more than 1 in 10 people) What are the possible side effects of BNT162b2? These results were observed 7 days following the second dose in study participants with no evidence of prior SARS-CoV-2 infection.Ī similar benefit of the vaccine was observed in subjects with one or more other medical conditions that increase the risk of severe COVID-19 disease, such as obesity, hypertension, diabetes, or asthma. Those who received vaccination with BNT162b2 had a reduction in the rate of COVID-19 illness compared to those who received placebo (8 cases of COVID-19 illness in the vaccinated group compared to 162 cases in the placebo group).
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.
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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. 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)
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