Alok Sharma defends UK’s rapid approval of Covid vaccine | Society

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The UK business secretary, Alok Sharma, has defended the UK’s “absolutely meticulous” approach to the coronavirus vaccine amid global criticism of its rapid approval by regulators.

Sharma said the UK should be “very proud” of becoming the first western country to give the green light to a Covid-19 jab as the government hit back at sceptics.

He described the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which approved the vaccine, as “very much regarded as the gold standard by international scientists” and added: “They’ve been absolutely meticulous in this whole process.

“The MHRA is of course independent and people should feel entirely confident that this vaccine is safe. If it wasn’t, it wouldn’t have been approved. It wouldn’t have got the clearance from the MHRA.”

Now that the UK has authorised the first Covid vaccine, who will get it first?

The government’s Joint Committee on Vaccination and Immunisation (JCVI) says its priority is to prevent Covid-related deaths and protect health and social care staff and systems.

Elderly care home residents and their carers are first on the JCVI’s list because their risk of exposure to the virus is higher and because the risk of death closely correlates with older age. They are followed in priority by anyone else over 80 and frontline health and social care workers.

Even so, for pragmatic reasons NHS staff are likely to be the first group to receive the Pfizer/BioNTech jab. This is because the vaccine needs to be stored at ultra-cold temperatures, which can be achieved more easily by using hospital facilities

Are there enough doses to reach all the priority groups?

Together, care home residents, their carers and the over-80s make up nearly 6 million people, and frontline NHS staff a further 736,685. Matt Hancock, the health secretary, has said he expects 10m doses of the Pfizer/BioNTech vaccine to be available this year, so if this is the only vaccine authorised, everyone else would have to wait until further doses become available next year. 

Where will I go for the vaccine?

Covid-19 vaccines are expected to be delivered at three types of venue: NHS trust “vaccine hubs” at hospital sites; mass vaccination centres, which are in the process of being set up at places such as football stadiums, conference buildings and racecourses – these are expected to vaccinate up to 5,000 people a day; and at GP surgeries and pharmacies. GPs can also visit care home residents and housebound patients at home without them needing to travel.

How far apart will the two doses be administered, and will I protected after the first?

While there is some evidence to indicate high levels of short-term protection from a single dose of vaccine, a two-dose schedule is what has been approved by the MHRA.

The second dose will need to be delivered at least 21 days after the first, and both will be injected into the deltoid muscle – the thick triangular muscle we use to raise each arm.

For the Pfizer vaccine, its efficacy rate was calculated seven days after the second shot. It is likely that people will have some protection before this, but this is how long it will take for full protection to kick in. We will learn more about the extent of protection and how long it lasts as data from ongoing clinical trials comes in.

Can I pay to get the vaccine privately?

Unlikely. England’s deputy chief medical officer, Jonathan Van-Tam, has said he believes Covid-19 vaccines should be delivered according to clinical priority rather than allowing people to jump the queue if they can afford it.

Will I be able to choose which vaccine I have?

Also unlikely, at least in the short to medium term. Assuming more than one vaccine is approved, the priority will be distributing any available doses to the people who need it as quickly as possible.

Linda Geddes

His comments came after Anthony Fauci, the US’s leading infectious disease scientist, said the MHRA had “rushed through” its approval, although he later apologised and blamed his remarks on a “misunderstanding”.

Fauci, who leads the US National Institute of Allergy and Infectious Diseases, initially said the UK “ran around the corner of the marathon and joined it in the last mile” and “rushed through that approval”.

He contrasted that with the approach of the US Food and Drug Administration (FDA), which he said had been careful to avoid “cutting corners” because it did not want to fuel vaccine scepticism.

Fauci later told the BBC he did not mean to imply “any sloppiness” and said: “I have a great deal of confidence in what the UK does both scientifically and from a regulator standpoint.”

Asked on Sky News on Thursday morning about Fauci’s comments, Sharma said: “You should also see what Dr Fauci has subsequently said overnight about the fact that he is confident in the processes that we have followed.

“I just want to make this point because you’re absolutely right about giving people the confidence that the vaccine is safe. The MHRA, which is the regulator in the UK, is independent. It’s also regarded actually as a gold standard of regulation by international scientists, people around the world.”

UK coronavirus cases

Dr June Raine, the head of the MHRA, had previously insisted that “no corners had been cut” in vetting the vaccine. Raine will reportedly undertake a series of interviews with local and commercial radio stations on Friday in an attempt to convince the public the vaccine is safe.

There are serious concerns within government that anti-vax campaigners are latching on to scepticism about the rapid approval of the immunisation.

The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

In the case of an mRNA vaccine, the virus’s mRNA is injected into the muscle, and our own cells then read it and synthesise the viral protein. The immune system reacts to these proteins – which can’t by themselves cause disease – just as if they’d been carried in on the whole virus. This generates a protective response that, studies suggest, lasts for some time.

The two first Covid-19 vaccines to announce phase 3 three trial results were mRNA-based. They were first off the blocks because, as soon as the genetic code of Sars-CoV-2 was known – it was published by the Chinese in January 2020 – companies that had been working on this technology were able to start producing the virus’s mRNA. Making conventional vaccines takes much longer.

Adam Finn, professor of paediatrics at the Bristol Children’s Vaccine Centre, University of Bristol

The deputy chief medical officer for England, Jonathan Van-Tam, also hit back at critics, telling the BBC: “If you’re a regulator who’s slightly further behind, what do you say to justify your position that you are further behind? Words such as the ones we’ve heard perhaps.”

The UK announced on Wednesday it had become the first western country to license a vaccine against Covid, opening the way for mass immunisation with the Pfizer/BioNTech vaccine to begin next week for those most at risk.

The first doses of the vaccine would arrive in the coming days, said the company. The UK has bought 40m doses of the vaccine, which has been shown to have 95% efficacy in its final trials.

Sharma said he was “very confident” that 800,000 doses of the jab would be available for the start of the rollout next week and that he hoped the UK would have “some millions by the end of this year”.

Hafta Ichi
Source: The Guardian
Keyword: Alok Sharma defends UK’s rapid approval of Covid vaccine | Society

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