[ad_1]
Routine safety monitoring and analysis of COVID-19 vaccines approved by the UK’s medicines regulatory body, the Medicines and Health Products Regulatory Agency (MHRA), shows that the safety of these vaccines remain as high as expected based on clinical trial data that supported the approvals. .
The safety profile of the vaccines remains positive and the benefits continue to far outweigh the known side effects.
Over 10 million doses of Pfizer (NYSE: PFE) / BioNTech (Nasdaq: BNTX) and Oxford University / AstraZeneca (LSE: AZN) vaccines have been administered across the UK and the MHRA has gathered a large amount of data security on their use.
The MHRA statement follows speculation about the efficacy in the elderly of the AstraZeneca vaccine, AZD1222, and after the European regulator recently granted conditional marketing authorization for this vaccine in all slices of age. However, across the European Union, a number of national regulatory bodies have stipulated that the vaccine should not be given to people over the age of 65 and in some cases even younger.
Data released today shows 22,820 reports of suspected side effects, for an overall reporting rate of 3 in 1,000 doses of vaccine administered from December 9, 2020 to January 24, 2021. These reassuring data showed that the vast majority of effects Secondary reported are mild and all comply with most types of vaccines, including the seasonal flu shot. These include sore arms and mild flu-like symptoms, which reflect a normal immune response to vaccines and are short-lived.
Security monitoring strategy
The MHRA also today released its Safety Oversight Strategy to monitor the safety of all UK-approved COVID-19 vaccines. This was informed by the government’s independent advisory body, the Commission on Human Medicines and UK public health sector expertise.
The MHRA also today released the first of what will be regular COVID-19 vaccine safety reports. These provide details of suspected vaccine side effects reported through its safety monitoring system, the Yellow Card Program. This data has been thoroughly analyzed by the scientists and security experts of the MHRA as well as all other sources of evidence.
Dr June Raine, Executive Director of the MHRA, said: “Vaccines are the most effective way to protect against COVID-19 and to save lives and prevent serious complications from this terrible virus. The data we have collected provides further assurance that COVID-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines. We remain convinced that the benefits of these vaccines outweigh the risks. “
[ad_2]
Source link
