UK first to approve new bivalent covid vaccine

[DownNative]

The UK has become the first country to approve a COVID vaccine that targets both the original strain and the Omicron variant.

The Moderna jab was given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator's standards of safety, quality and effectiveness.

The booster dose, known as "Spikevax bivalent Original/Omicron", contains 25 micrograms of Omicron vaccine and 25 micrograms of original coronavirus vaccine.

Vaccines that work for two infections are known as bivalents and have been developed by global manufacturers since the emergence of the Omicron variant.

Source: news.sky.com/story/uk-is-first-to-approve-covid-vaccine-targeting-original-strain-and-omicron-variant-12673637

It's Omicron still very prevalent then?
And it's it necessary for those who've likely had an Omicron infection?

From what I understand, it'll be given to the elderly and those with underlying health conditions from this autumn.

Omicron is still around, yes.

The US has already ordered bivalent vaccines from both Pfizer and Moderna. We've been told that distribution will start sometime in September, so FDA approval must be very nearly complete.

It's great news all around, and well done to the MHRA.

It is great news, indeed.

What has the MHRA done here? surely any regulator can approve a vaccine, its whether its safe or not that matters.
They approved AZ and that then had to be withdrawn for younger age groups.

The question i would want to ask is why hasn't anyone else approved the vaccine yet.

The way people are going on about this, you'd think Moderna was a UK company.

Excellent news. I'm looking forward to my parents getting it as they're still really worried about Covid, but it's becoming increasingly difficult for them to put life on hold.

I would like some myself but as I'm only 40 I guess it'll be a while!

They're the only UK regulator Sounds like other countries regulators will be approving very shortly too.

Correct. It's not a bad thing the UK has approved it before any other state.

Doh! never knew that!! 🙄

But really, it makes SFA difference, its just dick waving "we approved it before the EU shite"

The EU has already pre approved it, so actually were first and has a contract that will ensure all non delivered doses will be changed to the new vaxx, plus additional vaccines ordered.

Its all good news but i don't know why the UK has to be such jerks about it

How are we being dicks about it? Genuinely - it's being reported in the news. I haven't seen any politicians saying how superior the Uk is because our regulator has approved a drug that the rest of the world's regulators will also approve in a matter of days - have I missed some tbh g?

What I don't understand, and hoping someone clever can explain, is that this is for original covid variant and omicron 1, but we are already on omicron variants 4 & 5 so what benefit is it and isn't there likely to be another variant by the next wave which it won't cover🤔

Because the UKs amazing, envy of the world nhs is near complete collapse- 12hr wait times in a&e in Summer- they’d rush through anything in the vein hope it keeps 1-2 people out of a&e in the short term this winter.

Well I currently have covid, presumably the Omicron BA5 variant. I am on the mend, but have spent a week feeling like utter shit. Not as bad as when I had Delta.

TBH I'd have this new vaccine in my arm immediately if I could. I've coughed so violently, I've pissed myself and I had a nasty temperature a few days ago.

The new vaccine triggers a strong immune response against the Omicron (BA.1) variant. BA.1 is the variant that arrived before Christmas last year.

In the meantime, Omicron variants have been and gone. The new vaccine has poor performance against the current BA.5 variant.

The immunity generated by an omicron infection is likely to provide far superior immunity to the next variant than any vaccine based on BA.1.

But yes, we should all rejoice and pretend it is still 2021!

The new vaccine has poor performance against the current BA.5 variant.

According to this, The U.K. approved omicron-specific booster shots. They're coming to the U.S. soon "The Moderna shot approved Monday in the U.K. was less effective against BA.5 — though it still "generate[d] a good immune response" against that strain, researchers said."

The article also states that the version under review in the US targets the BA.5 variant, while the vaccine approved in the UK targets the BA.1 variant. So they are not identical, which may explain why the FDA is still reviewing the US application.

It has just a third of the immune response to BA.5 than it had to BA.1. The response to the next dominant variant will be lower still.

Also, a bivalent vaccine is less efficient than a monovalent Omicron booster.

I'm pleased we're still developing and approving these vaccines but I do worry about them. I'm in the age bracket to get this latest vaccination, and I should be very grateful, but I always wonder if we might have missed something along the way and there'll be a vaccine that has some nasty side effects or something. I suppose I'm not making sense here really.

I had all my jabs as they became due, of all the ones I had, the Moderna one was the nastiest, I had the worst reaction to it and I wasn't very happy for a day. But I shall go forward for the next one, I just think I'm more worried about them these days.

Horray for science!

Over 50 isn't elderly

It has just a third of the immune response to BA.5 than it had to BA.1.

Source for this?

I wonder if the MHRA is in the process of approving the vaccine that includes the BA.5 strain.

So, news organisations reporting this news means the UK are being "dicks about it"?

Do tell since you seem to know.....🙄

Pre-approving is not the same thing as approving.

Pre-approve = "at a stage before approval". Keyword is "pre".

"Moderna added that the bivalent vaccine generates antibodies that still block BA.4 and BA.5, although their levels were about three times lower than those against BA.1."

www.nature.com/articles/d41586-022-01771-3

This bivalent vaccine above would have been a great booster this time last year as BA.1 was taking hold. BA.1 and BA.2 have been and gone.

However, this bivalent vaccine will have little to offer in Autumn 2022 in a population where so many have already been infected with omicron during the year.

I'm glad it's happening, but whether we are first or not should not be something to shout about.

Why do you think the UK isn't looking at the bivalent vaccine that targets BA.5, which is what the US has ordered and is in the process of approving?

My understanding is that the UK ordered the BA.1 version of the vaccine.

The FDA asked the companies to re-tweak so that it's a better match against BA5 and that is the version that the US has ordered.