Covid-19 roundup: Moderna gets Swiss booster OK; Bivalent shots expect US EUA sans complete in-human data — report
After Moderna’s bivalent Omicron booster first got authorized in the UK, it was only a matter of time before other countries followed suit. We now know the next country to sign off on it: Switzerland.
Moderna put out word Monday that the regulatory agency Swissmedic gave a temporary thumbs up to the mRNA behemoth’s bivalent booster vaccine, mRNA-1273.214.
Per a press release, the booster is only authorized for adults. Half of the 50 µg vaccine targets the original virus strain, while the other half targets Omicron BA.1.
The decision from Swissmedic was based on clinical trial data from a Phase II/III trial that were read out in June, where the candidate met all primary endpoints , including a superior antibody response against Omicron, when compared to baseline in participants without antibodies.
The biotech already got authorization in the UK two weeks ago and decisions are still pending in other countries, such as Australia and Canada.
Moderna added that it is working with the Swiss government and Swissmedic to get the booster available in the country by sometime next month.
Omicron boosters expected to be FDA authorized before completion of in-human trials
Covid-19 booster shots — ones targeting the Omicron variant — are set to be authorized by the FDA this week before in-human testing is completed, according to a report from the Wall Street Journal published over the weekend.
The report noted FDA plans to examine the shots from a variety of other sources outside of clinical data, such as preclinical data from mice, the profiles of the original vaccines and the performance of earlier iterations of boosters.
“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA commissioner Rob Califf said in a series of tweets last week. The FDA chief also noted that strain changes can be done safely, and that the regulatory agency will not hold an adcomm to review the new submissions.
It also lines up 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, then the US will be set for a fall vaccination campaign.
Valneva turns over further positive Phase III data for adjuvanted Covid-19 vaccine
Valneva previously reported a positive Phase III readout for its adjuvanted Covid-19 vaccine candidate, VLA2001. Now, it’s got more to share.
The biotech put out word via statement Monday that additional readouts from Valneva’s Phase III trial showed “persistent immunogenicity and first positive heterologous booster results following primary vaccination.” That primary vaccination was with AstraZeneca’s vaccine ChAdOx1-S, also known as Covishield.
This is one of the newest developments for Valneva after its contract with Europe for 60 million doses collapsed, settling for just 1.25 million doses after the company’s regulatory review got stalled. The biotech had also fired back after a study late last year — touting some of its own booster data after a study published in the Lancet said that VLA2001 was the only one of 7 different vaccines that did not work well as a booster for a Pfizer or Moderna shot.
Per a release, neutralizing antibody titers induced by Valneva’s vaccine 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 reported to be efficacious against SARS-CoV-2 — around 90%. On top of that, a booster shot of VLA2001 was well tolerated in patients who had either VLA2001 or AstraZeneca’s Covishield before.
Valneva CMO Juan Carlos Jaramillo said in a statement that “we believe the robust immunogenicity and safety profile of our differentiated whole virus, inactivated vaccine remains compelling,” and the company looks forward to providing further data.