![]() The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care. ![]() The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products.The Joint Committee on Vaccination and Immunisation (JCVI) will advise on how this vaccine should be offered as part of the deployment programme. Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines said:įollowing an independent review of the safety, quality and effectiveness of the vaccine, the Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group supports the MHRA’s decision.Īs with any medicinal product, including vaccines, it is important to continually monitor effectiveness and safety when it is deployed, and we have the relevant processes and expertise in this country to do that. We have in place a comprehensive safety surveillance strategy for all UK-approved COVID-19 vaccines, and this will include the updated booster we approved today. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.īivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against COVID-19 variants. I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. Dr June Raine, MHRA Chief Executive said: Safety monitoring showed that the side effects observed were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, and no new serious safety concerns were identified. The MHRA’s decision is based on data from a clinical trial which showed that a booster dose with the bivalent Pfizer/BioNTech vaccine triggers a strong immune response against both Omicron and the original strain. In each dose of the booster vaccine, ‘Comirnaty bivalent Original/Omicron’, half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. Earlier studies involving people who received the original Moderna booster suggested that they generated higher levels of virus-fighting antibodies compared to people who received a Pfizer-BioNTech booster.A second, “bivalent” vaccine has today been approved as a booster by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness. But it may potentially come with an advantage, if the experience with the original booster shots is any guide. A higher dose means that people getting Moderna’s Omicron booster may experience slightly higher rates of side effects, such as swelling, arm soreness, fever, and fatigue compared to people who get Pfizer-BioNTech’s. The same is true of Moderna’s new Omicron booster. One thing to keep in mind, however, is that all along, Moderna’s vaccine doses have been slightly higher than those from Pfizer-BioNTech. ![]() It’s also not clear what happens, for instance, if someone who was vaccinated with Moderna’s shot, then boosted with Pfizer-BioNTech’s, now gets a Pfizer-BioNTech or Moderna Omicron booster.īut based on previous studies of mixing and matching, health officials are relatively confident that the booster doses are interchangeable, and the CDC says people over 18 “may get a different product for a booster than they got for their primary series, as long as it’s Pfizer-BioNTech or Moderna.” But human studies of the new Omicron boosters have not been completed yet-they will be launched in September-so there are no data yet on what happens when people who have been vaccinated with one company’s shots then get an Omicron booster made by a different company. That was the case with the original vaccines and boosters. Studies have shown that people who received mRNA booster doses of the original vaccine made by a different manufacturer than that of the primary series generated similar virus-fighting antibodies against SARS-CoV-2, compared to people who got the same brand of primary and booster shot. But the abundance of options means you may have already received a booster dose from a different manufacturer, and that’s just fine. Centers for Disease Control and Prevention (CDC) recommends that people not mix the two primary series doses of the mRNA vaccine-so if you’ve been vaccinated with Pfizer-BioNTech for your first dose, for example, your second dose should also be from Pfizer-BioNTech the same goes for Moderna.
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