The U.K. regulator has become the first to authorize Moderna’s bivalent COVID vaccine booster for use in adults aged 18 and older.
The Medicines and Healthcare products Regulatory Agency gave the nod to the booster, identified as mRNA-1273.214, which targets the original virus strain, as well as the omicron variant.
The decision was based on data from a Phase 2/3 trial that met all primary goals, including superior neutralizing antibody response against omicron (BA.1) when compared with a 50-milligram booster dose of mRNA-1273.
“A booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against omicron approximately 8-fold above baseline levels,” the company said in a statement.
The booster further “elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age,” it added.
Preliminary safety data from the trial showed the vaccine to be generally well-tolerated, and adverse events were low in number and balanced between vaccine and placebo groups and not considered related to the vaccine, the company said.
In the 12- through 17-year-old population, the Novavax’s vaccine has been granted authorization in India, the European Union, Australia, Thailand and Japan, and is actively under review in other markets, the company said.
The U.S. authorized the Novavax vaccine for adults aged 18 and older in July, adding a fourth option to the U.S. program and one that is more conventional than the mRNA vaccines developed by Moderna MRNA, +3.27% and Pfizer PFE, -0.72% and German partner BioNTech BNTX, +1.33%. The Janssen vaccine from Johnson & Johnson JNJ, +0.48% is of the viral-vector variety.
On Monday, the company applied for emergency-use authorization for a booster shot that would be offered to adults six months after the first two shots. The company said the booster has lifted antibody levels to comparable or even higher levels than seen after the primary doses.
U.S. known cases of COVID are continuing to ease based on numbers provided by a New York Times tracker, although the true tally is likely higher given how many people are testing at home, where the data are not being collected.
The daily average for new cases stood at 102,902 on Sunday, according to the New York Times tracker, down 17% from two weeks ago. Cases are falling in almost every state and are down 20% or more in more than a dozen states, namely Rhode Island, Texas, Nebraska, New Mexico, Florida, Idaho, Illinois, California, Arkansas, Louisiana, Oregon, New Jersey, Arizona, Hawaii, Alabama and Utah.
The daily average for hospitalizations was down 4% at 42,239, while the daily average for deaths is up 12% to 488.
Other COVID-19 news you should know about:
• Pfizer Chief Executive Albert Bourla has tested positive for COVID-19. He tweeted Monday that he has received four shots of the COVID-19 vaccine the company developed with BioNTech SE, is “experiencing very mild symptoms” and has started taking Paxlovid, Pfizer’s COVID-19 antiviral.
• China cut two key interest rates on Monday, in an effort to boost economic growth that has been disrupted by lockdowns in Shanghai and Wuhan due to its zero-COVID policy as it works to rein in cases driven by the BA.5 subvariant of omicron. The surprise cut and fresh funds pumped into the financial system to boost lending came after some weak data, as Barron’s reported. China’s economic activity is slowing across the board, from factory output to consumer spending and real estate. Chinese leaders have backed away from this year’s 5.5% growth target. The International Monetary Fund forecasts 3.3% growth for the year, which would be the lowest level in more than 40 years, outside of the pandemic.
• It’s a very different story for Japan, where the economy recovered its pre-pandemic size in the April-through-June quarter, with strong consumer spending after pandemic-related movement restrictions were lifted, the Wall Street Journal reported. The world’s third largest economy, after only the U.S. and China, expanded 0.5% in the three months to June from the previous quarter. That compares with a flat reading in the previous quarter and consensus forecasts for a 0.6% expansion. Adjusted for inflation and seasonal factors, Japan’s economy in the latest quarter was bigger than in the final quarter of 2019, the first time that has happened since the COVID-19 pandemic hit in early 2020. The economy expanded 2.2% on an annualized basis, which reflects what would happen if the second-quarter pace continued for a full year.
• Novak Djokovic pulled out of next week’s hardcourt tournament in Cincinnati on Friday because he has not gotten COVID-19 vaccine shots and so is not allowed to travel to the United States, the Associated Press reported. That is also why Djokovic is not expected to be able to enter the U.S. Open, the year’s last Grand Slam tournament, which begins in New York on Aug. 29.
Here’s what the numbers say
The global tally of confirmed cases of COVID-19 topped 590.6 million on Monday, while the death toll rose above 6.43 million, according to data aggregated by Johns Hopkins University.
The U.S. leads the world with 92.9 million cases and 1,037,053 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 223.5 million people living in the U.S. are fully vaccinated, equal to 67.3% of the total population. But just 107.9 million have had a first booster, equal to 48.3% of the vaccinated population.
Just 21 million of the people 50 years old and over who are eligible for a second booster have had one, equal to 32.7% of those who had a first booster.