The Oxford University/AstraZeneca vaccine
has been approved by the UK medicines regulator, opening up the possibility of
rapidly scaling up vaccination against Covid-19 within days.
The Medicines and Healthcare products
Regulatory Authority (MHRA) has approved the vaccine for use in the UK. Because
it needs only normal refrigeration at 2-8C and is easily transported, the
rollout to GP practices and care homes will be swift.
The first batches of vaccine are already in
the UK and more will be made in UK factories, ensuring a good supply. The UK
has ordered 100m doses, of which 4m are expected to be available within the
next few days.
Announcing the approval, the Department of
Health and Social Care (DHSC) said on Wednesday the vaccine would be available
for those at the highest risk of Covid-19.
The government’s joint committee on
vaccination and immunisation (JCVI) has advised that priority should be to give
as many people in at-risk groups their first dose of either the Oxford or
Pfizer vaccine, rather than providing the required two doses in as short a time
as possible.
“Everyone will still receive their second
dose and this will be within 12 weeks of their first. The second dose completes
the course and is important for longer term protection,” said a DHSC
spokesperson.
The decision to approve the vaccine
followed “rigorous clinical trials and a thorough analysis of the data by
experts at the MHRA, which has concluded that the vaccine has met its strict
standards of safety, quality and effectiveness”, the DHSC said.
The UK health secretary, Matt Hancock, has
said the approval signals a “route out” of the coronavirus pandemic.
He told Sky News: “I am now, with this
approval this morning, highly confident that we can get enough vulnerable
people vaccinated by the spring that we can now see the route out of this
pandemic.
“It is going to be a difficult few weeks
ahead. We can see the pressures right now on the NHS and it is absolutely
critical that people follow the rules and do everything they can to stop the
spread, particularly of the new variant of this virus that transmits so much
faster.
“But we also know that there is a route out
of this. The vaccine provides that route out. We have all just got to hold our
nerve over the weeks to come.”
Appraisal of the Oxford vaccine has taken
longer than it did for the Pfizer/BioNTech vaccine, which the UK approved
faster than any other regulator in the world on 2 December. The dossier of
testing and trial results for the Oxford vaccine is more complicated.
Pfizer/BioNTech, whose vaccine is based on
novel mRNA technology, had very positive and straightforward results, with 95%
efficacy from an international trial involving 43,000 people.
Oxford/AstraZeneca had 62% efficacy in
their largest trial, of 11,636 people, but 90% efficacy in a small additional
sub-group in the UK numbering 2,741 who were given a half dose of the vaccine,
followed by a whole dose four weeks later.
The researchers have pointed out that none
of the volunteers in the trials who had the vaccine became seriously ill or
were admitted to hospital.
AstraZeneca said its vaccine would be made
available to some of the poorest regions of the world at a low cost and not
being manufactured for profit.
Its chief executive, Pascal Soriot, said:
“Today is an important day for millions of people in the UK who will get access
to this new vaccine. It has been shown to be effective, well-tolerated, simple
to administer and is supplied by AstraZeneca at no profit.”
Trials of the vaccine are still taking
place to gather more data. AstraZeneca is running a large trial in the US and
it is not thought the US regulator, the Food and Drug Administration, will
approve the vaccine until that is complete. The FDA has also sought more data
on the protection the vaccine gives to older people and black and ethnic
minority groups.
Prof Andrew Pollard, the director of the
Oxford Vaccine Group and the chief investigator of the Oxford trial, said: “The
regulator’s assessment that this is a safe and effective vaccine is a landmark
moment, and an endorsement of the huge effort from a devoted international team
of researchers and our dedicated trial participants.
“Though this is just the beginning, we will
start to get ahead of the pandemic, protect health and economies when the
vulnerable are vaccinated everywhere, as many as possible as soon possible.”
Jonathan Ashworth, the shadow health
secretary, welcomed the news, tweeting: “Now let’s go hell for leather to get
jabs rolled out. We’ve seen how more virus circulating means opportunities for
variants to emerge. This is now a race against time. We need vaccination ramped
up especially for NHS staff urgently.”
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