Moderna gets Swiss booster OK; Bivalent shots expect US EUA without full human data – report – Endpoints News
After Moderna’s bivalent Omicron booster was first licensed in the UK, it was only a matter of time before other countries followed suit. We now know the next country to sign: Switzerland.
Moderna announced on Monday that regulatory agency Swissmedic has temporarily approved the mRNA behemoth’s bivalent booster vaccine, mRNA-1273.214.
According to a press release, the booster is only allowed for adults. Half of the 50 mcg vaccine targets the original viral strain, while the other half targets Omicron BA.1.
Swissmedic’s decision was based on clinical trial data from a phase II/III trial that were read in June, where the candidate met all primary endpoints, including a superior antibody response against Omicron, compared to baseline in participants without antibodies.
The biotech already got clearance in the UK two weeks ago and decisions are still pending in other countries, such as Australia and Canada.
Moderna added that it was working with the Swiss government and Swissmedic to have the booster available in the country by next month.
Omicron boosters should be cleared by the FDA before the end of human trials
According to a report from the wall street journal released over the weekend.
The report notes that the FDA plans to review snapshots from various other sources outside of clinical data, such as preclinical mouse data, original vaccine profiles, and performance of previous iterations of boosters.
“Real-world evidence from current mRNA Covid-19 vaccines, which have been given to millions of individuals, shows us that the vaccines are safe,” FDA Commissioner Rob Califf said in a series of briefings. tweets last week. The FDA chief also noted that strain changes can be made safely and the regulatory agency will not hold adcomms to review new submissions.
It also aligns with biotech and pharma expectations, after Moderna just finished submitting a bivalent Omicron candidate to the FDA last week. The booster, targeting BA.4 and BA.5 as well as the original strain and called mRNA-12.73.222, is currently in an ongoing Phase II/III trial. Pfizer and BioNTech also submitted theirs last week to the FDA for EUA.
If the FDA gives these two the green light, the United States will be ready for a fall vaccination campaign.
Valneva delivers new positive Phase III data for adjuvanted Covid-19 vaccine
Valneva previously announced a positive Phase III reading for its adjuvanted Covid-19 vaccine candidate, VLA2001. Now he has more to share.
The biotech announced in a statement on Monday that additional readings from Valneva’s phase III trial showed “persistent immunogenicity and the first positive heterologous booster results after the primary vaccination.” This primary vaccination was with AstraZeneca’s ChAdOx1-S vaccine, also known as Covishield.
It is one of the most recent developments for Valneva after its contract with Europe for 60 million doses collapsed, settling for just 1.25 million doses after regulatory review stalled. of the society. The biotech had also hit back after a study late last year – touting some of its own recall data after a study published in the Lancet said VLA2001 was the only one of 7 different vaccines that didn’t work well as a booster for a Pfizer or Moderna vaccine.
According to a statement, Valneva’s vaccine-induced neutralizing antibody titers were non-inferior to Covishield at day 71, including a similar level of Covid-19 cases between the two vaccine candidates.
The biotech noted that the vaccine was able to boost immunity to levels deemed effective against SARS-CoV-2 – around 90%. In addition to this, a booster injection of VLA2001 was well tolerated in patients who previously had VLA2001 or AstraZeneca’s Covishield.
Valneva CMO Juan Carlos Jaramillo said in a statement that “we believe the robustness of the immunogenicity and safety profile of our differentiated whole virus inactivated vaccine remains compelling,” and the company looks forward to provide additional data.