- The United Kingdom has become the first nation to approve Moderna’s bivalent COVID-19 vaccine.
- The vaccine was developed to target both the original strain and Omicron BA.1 variant of
SARS-CoV-2, the virus that causes COVID-19.
- The Joint committee on Vaccination and Immunisation (JVCI) will decide how the new vaccine will be offered and if it will be included in its wider fall immunization program against COVID-19 and the flu.
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The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) announced on Monday, August 15 that it had officially approved Moderna’s new updated COVID-19 vaccine targeting two different
In a press release, the MHRA said the vaccine would be used as a booster dose in adults after the vaccine passed tests of safety, quality, and effectiveness.
“The first generation of COVID-19 vaccines being used in the U.K. continue to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve,” said Dr. June Raine, MHRA chief executive.
The new Moderna booster dose is bivalent, meaning that it can fight two different variants of the virus. It is called “Spikevax bivalent Original/Omicron” and contains 50 micrograms of mRNA, half of which targets the original variant of SARS-CoV-2 from 2020, and the other half targets
A bivalent vaccine offers protection against two different antigens. Those can be either two separate viruses or two different strains of the same virus.
According to Dr. Richard Kennedy, co-director of the Vaccine Research Group at Mayo Clinic in Rochester, MN, the bivalent vaccine, in this case, has two different spike proteins.
“It will create an immune response (or boost an existing response) to the spike protein from the original strain of SARS-CoV-2 that we saw circulating at the start of the pandemic,” he explained to Medical News Today.
“It will also create an immune response against the spike protein found in the Omicron strain (BA.1) that started circulating in December of 2021. In people who have been infected with Omicron, it will boost that immune response.”
“This bivalent vaccine is a step in the right direction — it targets an early version of Omicron (BA.1), not the current strains,” Dr. Kennedy added.
“[The bivalent vaccine] also recognizes the reality of the situation: the original vaccines worked well but not well enough; the virus has changed considerably from the original strain that started the outbreak; the virus will continue to mutate and change, and we will see more variants in the future.”
— Dr. Richard Kennedy
Dr. Fady Youssef, a board-certified pulmonologist, internist, and critical care specialist at MemorialCare Long Beach Medical Center in Long Beach, CA, told MNT he was happy to see a vaccine targeting Omicron.
“We’ve been seeing a lot of breakthrough cases where patients who are vaccinated and boosted are getting COVID,” he explained.
“The big concern is going to be if we’re going to be able to rapidly develop boosters and vaccines targeting the variants as they keep emerging. Which one is going to happen faster — it’s a race between variants emerging and boosters being developed and safely approved to combat them,” he said.
The MHRA’s authorization is based upon clinical trial data from a phase 2/3 trial. The data are not publicly available but have been shared with regulators. The trial was conducted by Moderna, Inc. for the company’s Omicron-containing bivalent COVID-19 booster candidate mRNA-1273.214.
According to the company’s press release about the trial, the booster candidate contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant of concern.
Moderna reported trial participants who received a 50 µg booster dose of mRNA-1273.214 experienced a “superior neutralizing antibody response”, increasing geometric mean titers (GMT) 8-fold against the Omicron variant baseline levels one month after receiving the booster.
An earlier booster candidate from Moderna called mRNA-1273.211, reported on in April this year, resulted in a lower GMT increase of 2.2 fold. However, the data from this trial showed durability of response over 6 months. Moderna say they expect similar durability from mRNA-1273-214, and taken together with its superior immune boost response against variants of concern makes it their “lead candidate for a Fall 2022 booster”.
Moderna also reported the mRNA-1273.214 booster candidate was “generally well-tolerated” by participants with side effects comparable to the booster dose of the original mRNA-1273 vaccine at the 50 µg dose level.
The vaccine will be available in England, Scotland, and Wales, while Northern Ireland has received an emergency use authorization.
The U.K. Joint Committee on Vaccination and Immunisation (JCVI) recently published its advice on which vaccines should be part of the fall 2022 vaccine booster program.
The JCVI has added the Moderna mRNA (Spikevax) bivalent Omicron BA.1/Original ‘wild-type’ vaccine to its list of recommended vaccines for adults ages 18 years and older.
Dr. Kennedy stated that in July, the Food and Drug Administration (FDA) asked vaccine manufacturers to update their products to create boosters that target the latest Omicron subvariants (BA.4 and BA.5).
“SARS-CoV-2 has mutated enough that an immune response to the original strain or even one of the early variants (e.g., Alpha, Beta, Gamma) is less effective at recognizing and protecting us against later variants (e.g., Omicron BA.1 – BA.5),” he explained.
“Because this new vaccine includes the Omicron spike, it allows us to broaden the immune response to better recognize the virus strains that are causing disease right now.”
— Dr. Richard Kennedy
Dr. Youssef agreed, stating it is important at this time to have a COVID-19 vaccine booster targeting Omicron.
“I think the number of breakthrough cases is the main concern,” he said. “Patients that are vaccinated and sometimes patients who have been infected are getting reinfected. And patients that are vaccinated are getting breakthrough infections because the variants seem to evade the immunity that was developed in response to original vaccines and innate immunity.”
However, Dr. Kennedy cautioned this new booster vaccine is not perfect as researchers are still playing catch-up.
“This new vaccine contains an early version of Omicron (BA.1) that really isn’t circulating widely right now,” he detailed.
“Instead, we have new versions of Omicron (BA4, BA.5, BA.2.12.1) that have additional mutations not found in BA.1. The company says that the data for this new vaccine shows that the immune response does a much better job recognizing these new variants. This data is not yet publicly available, but if true, suggests that the bivalent vaccine will provide a better level of protection against the current variants,” he concluded.