UK first to approve Omicron COVID shot with Moderna nod
Last edited Mon Aug 15, 2022, 09:31 AM - Edit history (2)
Source: Reuters
LONDON, Aug 15 (Reuters) - Britain has become the first country to approve a COVID-19 vaccine that targets both the original and Omicron variant of the virus. The UK medicines regulator (MHRA) approved the so-called bivalent vaccine made by U.S. drug company Moderna (MRNA.O) as a booster for adults. The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said.
The MHRA also cited an exploratory analysis in which the shot was found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5. No serious safety concerns were identified with this new formulation, the agency added. Now approval has been secured, Britain's Joint Committee on Vaccination and Immunisation (JCVI) will advise on how the vaccine should be deployed in the country.
While existing COVID-19 vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved. "The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives," MHRA Chief Executive June Raine said in a statement. "What this bivalent vaccine gives us is a sharpened tool in our armoury to help protect us against this disease as the virus continues to evolve."
European Medicines Agency (EMA) officials expect COVID variant-adapted vaccines to be approved in the European Union by September, and have signalled the regulator is open to using shots targeting the older BA.1 variant this autumn, given those specifically targeting newer subvariants are further behind in clinical development. In contrast, the U.S. Food and Drug Administration (FDA) has said it will seek the specific inclusion of the newer BA.4 and BA.5 offshoots of Omicron in any new shots used domestically.
Read more: https://www.reuters.com/world/uk/variant-adapted-covid-vaccine-wins-first-approval-britain-2022-08-15/
This is Moderna's vaccine and hopefully CDC will get it approved this fall here in the U.S. FDA's VRBPAC met back on June 28th and gave a go-ahead for consideration of the bivalent-type vaccines.
Previous headline - Variant-adapted COVID vaccine wins first approval in Britain
Original article -
The the UK medicines regulator (MHRA) approved the so-called bivalent vaccine made by U.S. drug company Moderna (MRNA.O) as a booster for adults.
The agency's decision was based on clinical trial data that showed the booster triggered "a strong immune response" against both Omicron (BA.1) and the original 2020 virus, it said.
The MHRA also cited an exploratory analysis in which the shot was also found to generate a good immune response against the currently dominant Omicron offshoots BA.4 and BA.5.
= new reply since forum marked as read
Ty for sharing!
(this meeting was going on at the same time as one of the J6 hearings so I was streaming it, watching the J6 on TV, and managing the J6 "live threads"
).
They were looking at various combos of monovalent (targeted) versions of their vaccine vs bivalent ones and how these performed. For all of these companies, their initial attempts at targeting started before Omicron because Omicron was pretty late in the parade of variants, and they had a longer period of time to watch how they worked over time.
Once Omicron hit, they did start tweaking to create an Omicron-only one, the early results weren't promising.
I.e., the Omicron-only (monovalent) was not as effective against Omicron (the same happened early with Pfizer's too). However they were finding what they had put together as a combo of either with a Beta or an Omicron, was better against Omicron than the original, unmodified version of the vaccine by itself or the monovalent Omicron version by itself.
And based on what they presented, they apparently wanted to go with their bivalent (tweaked original + an Omicron) - the 1273.214 - which was also found to be effective against BA.4/BA.5.
But note that as of last week's CDC Nowcast, there's some mutated version of Omicron BA.4 starting to increase -
