Coronavirus UK: Calls to approve Oxford University vaccine ASAP

Pressure is mounting for Britain to approve Oxford University’s coronavirus vaccine to stop the spiralling outbreak that has wrecked Christmas for millions.

Oxford and AstraZeneca’s jab may now be the UK’s last hope for lifting lockdown rules before spring 2021 because the country can’t get enough doses of Pfizer’s or Moderna’s – which won’t come until March – to protect all vulnerable people.

The MHRA drugs regulator has been doing its final review of the vaccine for three weeks now, since November 27, with a decision expected by next Tuesday.

Scientists and politicians are calling for it to be green-lighted as soon as possible so it can be rushed out to stop the devastating epidemic.

The discovery of a mutated strain of the virus, which the Government claims is up to 70 per cent more infectious than its predecessor, has experts worried that even lockdowns now won’t be strong enough to contain the virus.

Schools face the prospect of total closure in the new year in some parts of the country and London and the South East may be stuck in Tier Four rules for months.

One top scientist said it is ‘pretty clear that for the UK either the AZ vaccine is approved or most people get Covid’, adding ‘every day delayed counts’.

A medical journal editor added: ‘Why is there a delay in approving the Oxford vaccine in the UK and India? Nothing could be more urgent.’

The vaccine is so crucial because Britain already has more than four million doses on standby, with 100million ordered in total, and it can be kept in a normal fridge, so the roll-out could, in theory, be started the day after it is approved and go extremely quickly into care homes, GP surgeries and pop-up vaccination centres nationwide.

MHRA regulators have been deciding whether to approve the coronavirus vaccine made by Oxford University and British pharmaceutical company AstraZeneca since November 27 (stock image)

The MHRA is doing a critical, detailed review of Oxford’s study to make sure the jab is safe and effective before it is given to millions of people.

However, they made a decision about Pfizer and BioNTech’s jab within 10 days of being instructed to do so by the Department of Health. 

Britain has ordered 40million doses of Pfizer’s vaccine, with around 500,000 already given out and more on the way, and seven million of the jab made by Moderna.

The US Government has an exclusive deal for Moderna’s jab meaning the UK can’t get hold of any until March 2021 – because of this the MHRA has not yet started analysing it, so its efforts can be focused on Oxford. 

It has now been 23 days since the MHRA was officially told to decide on whether to approve the Oxford vaccine.

The sticking point is that officials must decide whether people should get the full two doses – which the trial showed give 62 per cent protection against Covid-19 – or 1.5 doses, which a dosing error in the trial found may be 90 per cent effective.

There are not a lot of data for the group in which the vaccine worked better, and it didn’t include older people, which would mean the regulator may have to take a leap of faith if it goes for it.  

There are no signs that regulators are concerned about the safety of the vaccine, and AstraZeneca said even the less effective form of the jab was still good enough to meet standards and was better than a flu jab.

Calling for the vaccine to be approved, Theo Sanderson – a malaria expert at the Francis Crick Institute in London – yesterday said it was worth considering ‘approve AZ vaccine tomorrow provided risk is considered lower than risk of unprotected Covid infection’.

He said on Twitter: ‘Pretty clear that for the UK either the AZ vaccine is approved or most people get Covid. Hope the regulator is judging any risk of side effects in that context. Ever[y] day delayed counts.’

And editor-in-chief of the Blood Cancer Journal, Dr Vincent Rajkumar, in Minnesota, US, said: ‘Why is there a delay in approving the Oxford vaccine in the UK and India? Nothing could be more urgent.’ 

HOW DOES THE OXFORD VACCINE WORK?

The vaccine – called ChAdOx1 nCoV-19 – uses a harmless, weakened version of a common virus which causes a cold in chimpanzees.

Researchers have already used this technology to produce vaccines against a number of pathogens including flu and Zika.

The virus is genetically modified so that it is impossible for it to reproduce  in humans and cause infection.

Scientists have transferred the genetic instructions for coronavirus’s specific “spike protein” – which it needs to invade cells – to the vaccine.

When the vaccine enters cells inside the body, it uses this genetic code to force the body’s own cells to produce the surface spike protein of the coronavirus.

This induces an immune response because it makes those cells look like the virus, which effectively works as a training aid for the immune system to learn how to fight the virus if the real thing gets into the body.

In clinical trials Oxford’s vaccine was 62 per cent effective at preventing a coronavirus diagnosis if given as two doses, and 90 per cent when one half dose was given followed by a further full dose.

The difference, experts say, may be because a smaller dose the first time allows the body to create a better picture of what the virus will look like before it attempts to launch a full-scale attack, as with a full dose, giving quality first and then quantity later.

Lord Ralph Lucas, a Conservative member of the House of Lords, tweeted: ‘What reasons for not immediately approving the Oxford vaccine could possibly outweigh the damage done by not approving it?’

Former Liberal Democrat MP Mark Oaten added: ‘Race between virus and vaccine now. Approve Oxford ASAP and get army in for mass vaccination program’. 

An MHRA spokesperson said: ‘Our rolling review of the Oxford/AstraZeneca Covid-19 vaccine is ongoing.

‘Our process for approving vaccines is designed to make sure that any Covid-19 vaccine authorised meets the expected high standards of safety, quality and effectiveness.

‘Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency (MHRA), and no vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.’

The difficult part of analysing Oxford’s study will be disentangling results from a group that was accidentally given too little of the jab but developed stronger protection. 

A problem with manufacturing equipment that measured the strength of doses meant that one batch was ‘over-estimated’, so scientists shrunk the doses to avoid giving people too much.

They pressed ahead with the trial, with the blessing of the MHRA, and gave those volunteers – and all other volunteers – full doses for the rest of the study, the team explained after their results were published in November.

And later, when those people didn’t get side effects that were as strong, the researchers found out exactly how much smaller the doses had been. 

The study results showed them that the vaccine was 90 per cent effective when given in 1.5 doses with the half-dose first, compared to 62 per cent when given in two full doses.

The MHRA now faces a dilemma and must choose whether to give approval for the 90 per cent effective regime to be given to the public, despite a smaller amount of data – it was only given to around 2,000 people.  

Professor Sarah Gilbert, who masterminded the potentially life-saving jab, said today it was ‘up to regulators’ to choose which regimen to rubber-stamp – but noted the half-dose had only been tested in under 55s. 

‘They will consider all of the data that’s been submitted to them,’ she said, ‘and we do have measurements of the immune response in older people and show that it doesn’t decline at all in people even aged over 70’.

She has previously said the half dose may be more effective because it would prime the immune system before a second full dose triggers a stronger immune response.

Scientists are still in the dark about which dosing regime the MHRA will choose – or whether it is happy with both of them – but are confident the evidence is good enough for either to be approved. 

HOW DO THE OXFORD, MODERNA AND PFIZER/BIONTECH VACCINES COMPARE? 

Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective. 

Oxford University has published the findings from its second phase, which show the jab provokes an immune response and is safe to use – it is not yet clear how well it protects against coronavirus in the real world.

Here’s how they compare: 

PFIZER (US) & BIONTECH (DE)

mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making ‘spike’ proteins and learning how to attack them.

mRNA vaccine – both Moderna’s and Pfizer and BioNTech’s vaccines work in the same way.

Recombinant viral vector vaccine – a harmless cold virus taken from chimpanzees was edited to produce the ‘spike’ proteins and look like the coronavirus.

94.5% effective (90 positive in placebo group, 5 positive in vaccine group) .

95% effective (160 positive in placebo group, 8 positive in vaccine group).

62% – 90% effective, depending on dosing. Average 70.4%.

Moderna confirmed it will charge countries placing smaller orders, such as the UK’s seven million doses, between £24 and £28 per dose. US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose.

The US will pay $1.95bn (£1.48bn) for the first 100m doses, a cost of $19.50 (£14.80) per dose.

Expected to cost £2.23 per dose. The UK’s full 100m dose supply could amount to just £223million.

UK has ordered five million doses which will become available from March 2021. Moderna will produce 20m doses this year, expected to stay in the US. 

UK has already ordered 40million doses, of which 10million could be available in 2020. First vaccinations expected in December.

UK has already ordered 100million doses and is expected to be first in line to get it once approved.

What side effects does it cause? 

Moderna said the vaccine is ‘generally safe and well tolerated’. Most side effects were mild or moderate but included pain, fatigue and headache, which were ‘generally’ short-lived. 

Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee ‘has not reported any serious safety concerns’.

Oxford and AstraZeneca said there are no serious safety concerns about the vaccine. Phase three trial saw three out of 23,745 participants have ‘serious adverse events’ that were ‘possibly’ linked to the vaccine. All three have recovered or are recovering, and remain in the trial.