The U.K. has authorized Moderna’s Covid vaccine that targets two different variants of the virus, the nation’s medicines regulator announcedon Monday, a world first as pharma firms adapt to a changed viral landscape and countries prepare to launch fall booster campaigns.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorized the shot, known as “Spikevax bivalent Original/Omicron,” for use as a booster vaccine in adults.
It makes the U.K. the first country in the world to greenlight the two-in-one shot, known as a bivalent vaccine, which contains half original vaccine and half omicron-specific vaccine.
It is specifically designed to target the first omicron variant, BA.1, which propelled a tsunami of cases in Britain last winter, in addition to the original strain.
The MHRA said trials showed the vaccine triggered a “strong immune response” against both BA.1 and the original strain and analysis found it could also “generate a good immune response” against the newer omicron variants BA.4 and BA.5.
Dr. June Raine, MHRA chief executive, said that while the first-generation vaccine still provides “important protection against disease” the bivalent vaccine provides “a sharpened tool in our armory” to help protect us as the virus evolves.
Moderna chief Stéphane Bancel praised the decision and said the vaccine offers broader immunity than the original vaccine, adding that the shot has an “important role to play” in protecting people against Covid-19 as winter approaches.
The virus circulating today has shifted significantly from the original one identified back in 2020. Vaccines, meanwhile, are still based on the original variant and while they still provide strong protection against serious illness, hospitalization and death, experts fear this could change with future variants. Most major Covid vaccine makers—including Pfizer, Moderna, Johnson & Johnson and Novavax—have been working on shots specific to the omicron variant to address waning effectiveness against the variant and some are working on bivalent varieties to cover more bases. Moderna had hoped to market the shot in the U.S. but in late June, the Food and Drug Administration told manufacturers to develop shots to specifically target the BA.4 and BA.5 variants, which now make up the vast majority of cases in the country.
WHAT WE DON’T KNOW
Who will be eligible for a booster shot. All people 16 and over have been offered first booster jabs in the U.K.. The government has announced plans to offer additional shots to some groups—including everyone 50 years old and older, healthcare workers, social care workers and people ages 5 and older with health conditions putting them at high risk of serious Covid—in the fall, around a year after the first wave of boosters were given. The response may broaden if officials believe circumstances justify a wider rollout. Plans have changed in the past. Under the original plans those ages 50-65 were not going to be boosted but the government expanded eligibility due to the high number of cases caused by omicron.
By Robert Hart, Forbes Staff