The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on Aug. 15 that the vaccine has been found to meet the UK regulator’s standards of safety, quality, and effectiveness.
MHRA Chief Executive Dr. June Raine said that the jab was found in the clinical trial to provide “a strong immune response against the Omicron BA.1 variant as well as the original 2020 strain.”
The new “bivalent vaccine” offers “a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve,” she said.
Moderna Chief Executive Stephane Bancel said the company is “delighted” with the UK’s authorisation of the new jab.
He described it as a “next generation COVID-19 vaccine” which will play an “important role in protecting people in the UK” from the virus over the winter.
Bancel added that the jab has “consistently shown superior breadth of immune response” over alternatives in clinical trials.
Side Effects ‘Typically Mild’
The MHRA said that the vaccine’s side effects are the same as those seen in the original Moderna booster dose and were “typically mild and self-resolving.”
“No serious safety concerns were identified,” the regulator said.
Raine said the regulator has “in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this will include the vaccine approved today.”
But there have been well-documented cases of side effects associated with previous COVID-19 vaccines produced by Moderna.
The risk of myocarditis after receiving the Moderna vaccine was 30 times greater than unvaccinated control groups, and the largest association for myocarditis following the Moderna jab was 44 times higher risk for persons aged 18 to 24 years.
The U.S. vaccine maker admitted in June that more than 1,000 cases of myocarditis had been detected in recipients of Moderna’s COVID-19 vaccine who are under 40 years old.
The company did not report cases of pericarditis, another heart inflammation condition that has been linked with the vaccines produced by both it and Pfizer.
Both myocarditis and pericarditis can have serious repercussions, with doctors often ordering patients to stop all physical activity for a period of time.
Zachary Stieber and PA Media contributed to this report.