personalising content and ads, providing social media features and to Added an accessible HTML document: Summary of the Public Assessment Report, Added the Public Assessment Report for the Pfizer/BioNTech COVID-19 vaccine. There has also been an update to the product information for the Comirnaty vaccines on myocarditis and pericarditis after a third dose and in the age group 5-11 years. if you are allergic to the active substance or any of the other ingredients of this medicine, ever had a severe allergic reaction or breathing problems after any other vaccine injection or after you were given COVID-19. Updates to the SmPC and PIL to include information about receiving a heterologous booster dose in individuals aged 18 years and over. This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/information-for-uk-recipients-on-pfizerbiontech-covid-19-vaccine. Kupferbergterrasse 17-19 Do not drive or operate machinery until you are sure that you are not affected. This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder 2. Any changes made can be done at any time and will become effective at the end of the trial period, allowing you to retain full access for 4 weeks, even if you downgrade or cancel. To help us improve GOV.UK, wed like to know more about your visit today. Supply of the vaccine is now in accordance with the Marketing Authorisation with all remaining Regulation 174 stocks expiring at the end of February 2022. Changes to section 4.2 and 6 of the Information for UK Healthcare Professionals to provide clarification following further feedback and update to section 4.4 to strengthen information on special warnings and precautions for use. Updated the shelf life life from 6 months to 9 months. a weakened immune system, such as due to HIV infection, or are on a medicine that affects your immune system, a bleeding problem, bruise easily or use a medicine to inhibit blood clotting, allergic reactions such as rash or itching, allergic reactions such as hives or swelling of the face, inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain, extensive swelling of the vaccinated limb, swelling of the face (swelling of the face may occur in patients who have had facial dermatological fillers), a skin reaction that causes red spots or patches on the skin, that may look like a target or bulls-eye with a dark red centre surrounded by paler red rings (erythema multiforme), This vaccine contains polyethylene glycol/macrogol (PEG) as part of ALC-0159, ALC-0315 = (4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), ALC-0159 = 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine. The Pfizer BioNTech vaccine against COVID-19 has very high efficacy against severe disease and moderate efficacy against symptomatic SARS-CoV-2 infection. Multiple travel industry officials have said that the requirement on foreign visitors, which has resulted in a handful of high-profile spats over unvaccinated athletes and celebrities being denied entry into the country, is widely expected to be allowed to expire. Regulatory documents remain unchanged. Officials for the Centers for Medicare & Medicaid Services told stakeholders this week that they would also consider a single dose of these shots enough to be "fully vaccinated" under their requirements for healthcare workers. "Because some traveler vaccine records might not specify whether . A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. The U.S. COVID-19 public health emergency and Illinois' statewide disaster declaration are set to end May 11. ARCHIVE: Information for UK recipients on Pfizer/BioNTech COVID-19 Updated Conditions of Authorisation, Information for Healthcare Professionals and Information for UK Recipients documents in line with an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds. hb``Pa``nd```c Individuals 6 months through 4 years of age: Unvaccinated individuals: Three doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are administered over at least 11 weeks. A vial of Pfizer-Biontech COVID-19 vaccine is seen at a Clalit health clinic in Jerusalem on August 8, 2021. The website decision page for the mRNA COVID-19 vaccines has been updated to reflect the fact that the 15-minute observation period following vaccination has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses. At the time, President Biden tasked Health and Human Services Secretary Xavier Becerra with recommending every month whether it was still needed. Additional information on Pfizer-BioNTech storage and handling can be found on CDC's Pfizer- Storage in boxes or bins can help maintain temperature longer, especially if power is lost. COVID-19 Vaccine Storage & Expiry - AAP or Updated the Information for UK recipients and the Information for healthcare professionals documents, to reflect changes to the dosage interval, advice for women who are pregnant or breastfeeding and to those with allergies. You may change or cancel your subscription or trial at any time online. Read . Log in. CDC eases COVID vaccination rule on international travelers, as The GB CMA was converted to a full MA on 9 November 2022. It will take only 2 minutes to fill in. The first two doses are. A temporary suspension will also apply for infants and children aged 6 months to 4 years, should this age group be included in the vaccination programme. Product information has been added for a new presentation of the vaccine for use in those aged 6 months to 4 years. We use European Union's Amended COVID-19 Vaccine Deal with Pfizer-BioNTech Latest COVID booster guidance; new subvariant, Latest COVID booster guidance as new Arcturus subvariant spreads, Public File for KMAX-TV / Good Day Sacramento. 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