By Charlotte Webster-
Approval has today been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a Pfizer/BioNTech ‘bivalent’ Covid vaccine that targets both the Original strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 sub-variants. The updated booster vaccine is the second bivalent vaccine from Pfizer/BioNTech to receive MHRA approval, after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.
The vaccine has been approved for use as a booster dose in individuals aged 12 years and above. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.
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In each dose of the booster vaccine, half of the vaccine (15 micrograms) is said to target the original virus strain and the other half (15 micrograms) targets Omicron (BA.4-5).
The MHRA’s decision is based on all available evidence on the original Pfizer/BioNTech COVID-19 vaccine and its adapted vaccines. This includes extensive safety and effectiveness data for the original vaccine, clinical data from the bivalent original/omicron BA.1 vaccine,and safety data from an on-going clinical trial.
The data show that the common side effects observed with the new bivalent vaccine were similar to those seen for other versions of the vaccine. These side-effects were typically mild and self-resolving, with no new safety concerns identified.
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Vaccines have been a controversial topic of discussion since the pandemic, given all the hysteria surrounding the virus. The stressed importance of being vaccinated has been pitted with concerns of some parents and from people of various demographics. The vast majority of the British public have been vaccinated or double vaccinated, but ,many parents became every concerned when school children of 12 were to be offered vaccination. without necessarily needing parental consent, if the child is deemed mature enough.
The Department of Health’s position is that the matter of Health was so serious enough to allow a framework for discretion if the child was adequately mature. Opinion was sharply divided over the proposals, ultimately parents of school pupils made the decisions in most cases.
All approved covid booster vaccines have the ultimate goal of improving the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19.
The approval from the regulator today comes as BioNTech reported vaccine sales at 3.5 billion euros for the quarter, stunning analysts who zeroed in on a consensus figure of 1.9 billion euros. In September, analysts from ODDO BHF projected the company’s annual figure to come out to 14.1 billion euros ($14.1 billion).
The company said it expects to supply 2.1 billion doses of the shot this year, fulfilling contracts with Europe for delivery of 650 million doses and with the U.S. to provide 105 million doses. BioNTech also has “deployed more than 300 million doses of our variant-adapted vaccine as of mid-October,” Ryan Richardson, BioNTech’s chief strategy officer, said on a conference call.
It demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study
Pfizer and BioNTech jointly announced the success of its vaccine in being more than 90% effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.
The study which enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed. It evaluated 94 confirmed czses of COVID-19 among participants.
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