Covid-19 roundup: Moderna showcases progress on its bivalent booster; Novavax wins approval in Japan
New data from Moderna offer encouraging results for the mRNA powerhouse’s bivalent booster candidate.
The bivalent booster candidate, known as mRNA-1273.211 and which includes mutations found in the Beta variant of concern, bested the company’s original booster in terms of neutralizing titers against all variants of concern, including Omicron.
The news, which follows similar results for the Pfizer/BioNTech Covid-19 vaccine when combined with Beta, bodes well for the booster in the fall.
“We believe that these results validate our bivalent strategy, which we announced and began pursuing in February 2021. The results indicate that mRNA-1273.211 at the 50-µg dose level induced higher antibody responses than the 50-µg mRNA-1273 booster, even when additional variants of concern were not included in the booster vaccine,” Stéphane Bancel, CEO of Moderna, said in a statement. “Our latest bivalent booster candidate, mRNA-1273.214, which combines the currently authorized Moderna COVID-19 booster with our Omicron-specific booster candidate, remains our lead candidate for the fall 2022 Northern Hemisphere booster. We look forward to sharing initial data on mRNA-1273.214 later in the second quarter.”
The company on Tuesday revealed a 2.2-fold (95% CI: 1.74, 2.79) and 2.15-fold (95% CI: 1.66, 2.78) increase in the neutralizing antibody titers against Omicron with the mRNA-1273.211 booster dose compared to the Spikevax booster dose at one month and six months, respectively, among 895 participants in the study.
Nuvaxovid Covid-19 vaccine and booster receive approval in Japan
Novavax has now seen its Covid-19 vaccine authorized in just about every country except for the US, as Japan on Tuesday became the latest to OK the shot.
Novavax and its partner Takeda received manufacturing and marketing approval from the Japan Ministry of Health, Labor and Welfare for the injection, which is now approved for primary and booster immunization in individuals aged 18 and older with distribution starting as soon as possible.
The vaccine, known as Nuvaxovid, is the first protein-based vaccine to be authorized for use in Japan.
“Together with Takeda, we are pleased to be able to offer the first protein-based COVID-19 vaccine to adults aged 18 and over in Japan,” said Stanley Erck, president and CEO of Novavax. “This approval is significant because it includes both primary and booster vaccination.”
The approval is based on Takeda’s NDA submission which included positive interim results from a Phase I/II study conducted by Takeda in Japan and several studies conducted by Novavax, including two pivotal Phase III clinical trials in the UK, US and Mexico as well as Phase I/II studies in Australia and the US. Additional safety and efficacy data were submitted for booster immunization review, which included a Phase II study conducted by Novavax in South Africa for a single vaccination given six months after primary immunization.
According to Novavax, Takeda will manufacture the vaccine at its Hikari-based facility. Takeda and the Japanese government have agreed to make and supply about 400 million doses of the Novavax shot.
Mask enforcement to become more relaxed as federal judge drops mandate
Federal officials will no longer enforce a mask mandate after a federal judge struck down the requirement to wear a mask on buses, trains and airplanes as well as in transportation hubs including airports.
US District Judge Kathryn Kimball Mizelle of Florida said the mandate exceeds the statutory authority of the CDC. The case was brought on behalf of a conservative legal group known as Health Freedom Defense Fund and as well as several airline passengers.
The judge ruled in favor of the plaintiffs on several key issues, finding that the CDC had exceeded its legal authority, and the mandate’s failure to provide notice and comment was not a harmless error.
A new team at the CDC plans to provide better and faster info on Covid-19
A new team of federal health scientists at the CDC will provide better, faster information about what is likely to happen next in this public health emergency and future infectious disease outbreaks.
According to the Washington Post, around 100 scientists will be a part of this team, analyzing technical data and policy options for decision-makers and the public about how the virus is behaving and who is most at risk but using user-friendly terms.
To be known as the Center for Forecasting and Outbreak Analytics, which starts with $200 million in funding, the center was created in 2021 to improve the understanding of the CDC and the government more broadly of Covid-19 and any future outbreaks in real-time.
This effort will also act as a boon to get ahead of any potential future pandemics as there is no national system for infectious disease forecasting. The center will also provide support and analyses to decision-makers at both the federal level and to states. This includes forecasting how many Covid cases might be expected in the coming days and weeks by analyzing the number of new cases and hospitalizations as well as examining the populations most affected.
The center will also analyze the spread of infections, vaccine protection against severe illness, the impact of variants on vaccines and the time since vaccination.