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The rest amoxil for a this document, including sections amoxil for a clinical aspects, user consultation, and the overall conclusion, can be found in the PDF. Contents Print this amoxil for a Is this page useful. The product will be referred to as BNT162b2 in this lay summary for ease of reading. What is BNT162b2 and what is it used for. How does BNT162b2 work. How is BNT162b2 used. This vaccine can amoxil for a be amoxil for a with a prescription.

What amoxil for a of BNT162b2 have been shown in studies. What are the possible side effects of BNT162b2. Why was BNT162b2 approved. What measures are being taken to ensure the safe and effective amoxil for a of BNT162b2.

Other information about BNT162b2 Authorisation for the temporary supply of BNT162b2 was granted in the UK on 1 December 2020. The full public assessment report for BNT162b2 follows this summary. This summary was last updated in June 2021. Introduction This report is based on the information provided by the company in a rolling data submission procedure and it covers the authorisation for temporary supply of BNT162b2.

Immunological agent for active immunisation (anti-SARS-CoV-2) Appearance: Clear to slightly opalescent, colourless to slightly brown liquid BNT162b2 RNA is not the subject of a European Pharmacopoeia monograph (Ph. Pharmaceutical development The manufacturer has described the finished product development strategy.

Manufacture of the product A description of the manufacturing method for COVID-19 mRNA Vaccine BNT162b2 has been provided and consists amoxil for a thawing and dilution of the drug substance, lipid nanoparticle formation upon mixing organic and aqueous phases (where specialised equipment is used for LNP formation), buffer exchange, concentration, filtration, formulation, sterile filtration, aseptic filling, visual inspection, labelling and freezing, and storage packaging and shipment.

Excipients The excipients sucrose, sodium chloride, potassium chloride, dibasic sodium phosphate dihydrate, monobasic potassium phosphate and water for injection are all of Ph. The controls in place for the excipients are considered suitable for this application. Excipients of human and animal origin No excipients of animal or human origin are used in the finished product. Novel excipients ALC-0315 is a cationic lipid and is critical to the self-assembly amoxil for a of the particle itself, the ability of the particle to be taken up amoxil for a cells and the escape of the RNA from the endosome.

Finished product amoxil for a The product specification includes relevant control parameters considering the nature of the product and its manufacturing process. Independent batch testing Independent batch testing is required for vaccines and provides additional assurance of quality before a batch is made available to the market.

Characterisation of impurities The impurity profile amoxil for a the BNT162b2 drug product is based primarily on the impurity profile of the materials used for its manufacture. The infertility impurities are controlled through the acceptance criteria used for their manufacture. Reference standards or materials The manufacturer has defined reference materials that are used in the determination of drug product content and in the determination of lipid content for the four lipids used for nanoparticle formation.

Container closure system Overall, the container closure system has been well described and complies with the relevant quality standards of the Ph. Stability The manufacturer has provided amoxil for a stability amoxil for a available to date. Deployment of this vaccine is subject to the conditions of this Regulation 174 approval.

Handling amoxil for a Pfizer Vaccine BNT162b2 Amoxil for a nanoparticles (LNPs) are complex particles made of four lipid components that entrap the mRNA.

Long term storage: It must be stored frozen at ultra-low temperature (ULT). Once thawed, the vaccine cannot be refrozen. Once diluted, the vials should be marked with the dilution date and time.

Following dilution, vials should be used in the shortest time period possible. The amoxil for a non-clinical studies were submitted with this application: Pharmacology Study 20-0211: In vitro expression of BNT162b2 drug substance and drug product Study R-20-0085: COVID-19: Immunogenicity of BNT162b2 in mice Study R-20-0112: Characterizing the immunophenotype in spleen and lymph node of mice treated with SARS-CoV-2 vaccine candidates Study VR-VTR-10671: BNT162b2 immunogenicity and evaluation of amoxil for a against SARS-CoV-2 challenge in amoxil for a macaques Pharmacokinetics Study PF-07302048: Single dose pharmacokinetics study of ALC-0315 and ALC-0159 following intravenous bolus injection of a nanoparticle formulation norethisterone rats Study R-20-0072: Biodistribution of BNT162b2 using the luciferase protein as a surrogate marker protein after intramuscular injection in mice.

Toxicology Study 38166: Repeat-dose toxicity study of three LNP-formulated RNA platforms encoding for viral proteins by repeated intramuscular administration to Wistar Han rats Study 20GR142: 17-day Intramuscular Toxicity Study of BNT162b2 and BNT162b3 in Wistar Han Rats These studies were conducted in accordance amoxil for a current Good Laboratory Practice (GLP).

Absorption No absorption studies were conducted for COVID-19 mRNA Vaccine BNT162b2 since the route of administration is intramuscular (IM). Distribution Study R-20-0072 evaluated the in vivo potential biodistribution of COVID-19 mRNA Vaccine BNT162b2 in mice using luciferase expression Irbesartan (Avapro)- Multum a surrogate reporter.

Metabolism The in vitro metabolism of ALC-0315 and ALC-0159 was evaluated in blood, liver microsomes, S9 fractions, and hepatocytes from mice, rats, monkeys, and humans. Excretion No excretion studies have been conducted with COVID-19 mRNA Vaccine BNT162b2.

Pharmacokinetic drug interactions No PK drug interaction studies have been conducted with COVID-19 mRNA Vaccine BNT162b2. Repeat-dose toxicity Study 38166 was a GLP-compliant repeat-dose study performed in rats to evaluate toxicity of the LNP and mRNA platform used in BNT162b2. No amoxil for a deaths were observed. Toxicokinetics No toxicokinetic studies have been performed with the vaccine.

Genotoxicity No genotoxicity studies are planned for BNT162b2, as the components of all vaccine constructs are lipids and RNA that are not expected to have genotoxic potential (WHO, 2005).

Carcinogenicity Carcinogenicity studies with BNT162b2 have not been conducted as the components of all vaccine constructs are lipids and RNA that are not expected to have carcinogenic or tumorigenic potential. Reproductive and developmental toxicity Fertility and early embryonic development and embryofoetal development In the general toxicity studies, macroscopic and microscopic evaluation of male and female reproductive tissues showed no evidence of toxicity.

Local tolerance No such studies have been done. Other toxicity studies No such studies have been done. Toxicity conclusions The absence of reproductive toxicity data is a reflection of the speed of development to first identify and select COVID-19 mRNA Vaccine BNT162b2 for clinical testing and its rapid development to amoxil for a the ongoing urgent health need.

Further information The rest of this document, including sections on clinical aspects, user consultation, and the overall conclusion, can be found in the PDF.



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