Jumat, 05 Februari 2021

COVID-19: Vaccines found to be 'extremely safe' - as UK orders 50m doses of CureVac jabs to fight variants - Sky News

Existing COVID vaccines in the UK are meeting strict safety standards, according to the UK's regulator - while the government has signed a deal to rapidly develop fresh jabs in response to new coronavirus variants.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Friday published the first of what will be regular vaccine safety reports, following its approval of the Pfizer/BioNTech and Oxford/AstraZeneca jabs last year.

More than 10 million vaccine doses have since been given in the UK.

The regulator found that "approved vaccines meet strict regulatory standards for safety" and that their safety was "as high as expected from the clinical trial data that supported the approvals".

The MHRA also said that the vast majority of reported side effects are "mild and short lasting, reflecting a normal immune response to vaccines - including a sore arm and fatigue".

They added that analysis showed a reporting rate of three suspected side-effects for every 1,000 doses of vaccine administered, and that the "benefits of the COVID-19 vaccines outweigh the risks".

Professor Sir Munir Pirmohamed, chairman of the expert working group of the Independent Commission on Human Medicines, said COVID vaccines were "extremely safe".

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"The benefits far outweigh the risks. I say that to my family as well," he added.

From 9 December to 24 January, the MHRA received 22,820 reports of suspected side-effects, with the vast majority being mild and in line with most other types of vaccine - such as the annual flu jab.

Dr June Raine, the MHRA's chief executive, said: "The data we have collected provides further reassurance that the COVID-19 vaccines are safe and continue to meet the rigorous regulatory standards required for all vaccines.

"We remain confident that the benefits of these vaccines outweigh any risks."

She added the MHRA would "continue to analyse, monitor and review all the safety data for these vaccines".

The MHRA has approved a third coronavirus vaccine, developed by Moderna, for use in the UK - although supplies are not expected to arrive until later this year.

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'Mutations of concern' specified by health sec

Meanwhile, the government has reached a deal with vaccine manufacturer CureVac for an initial order for 50 million doses of new vaccines if they are needed to respond to new COVID variants.

The government said both the Pfizer/BioNTech and Oxford/AstraZeneca vaccines appear to work well against the COVID variants currently dominant in the UK.

But fears of a COVID variant developing that is resistant to existing vaccines has seen ministers strike the partnership with the German company.

Under the new agreement with CureVac, who are working with drugs giant GlaxoSmithKline on a vaccine candidate, UK expertise on genomics and virus sequencing will help allow new varieties of vaccines based on mRNA technology to be developed quickly.

A new expert advisory group will be established to identify the variants that the UK could need vaccines against.

And the partnership with CureVac is aimed at boosting the UK's capacity to develop and manufacture variant vaccines in the UK.

Almost all vaccines developed through the agreement will be variants of an existing jab by CureVac, which is currently undergoing Phase 3 clinical trials.

The government said this means it should be possible to accelerate clinical trials ahead of submission to the regulator for approval.

The process is similar to the method used to update flu vaccines each year.

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Health Secretary Matt Hancock said: "The vaccines we are deploying now are safe and effective, with the latest evidence suggesting they provide protection against new strains of COVID-19.

"But we must be prepared for all eventualities and bolster onshore UK manufacturing capacity to develop vaccines to combat new variants of the disease, taking advantage of our world-leading genomics expertise."

England's deputy chief medical officer, Professor Jonathan Van-Tam, said: "The virus continues to mutate and it is likely that our vaccines will have to adapt to continue to offer the best possible protection.

"Being able to create these new vaccines at speed will allow our scientists to keep ahead of the virus as they do every year with the influenza vaccine."

Vaccines using mRNA technology, such as the Pfizer/BioNTech and Moderna jabs, are likely to quicker reformulate against variants than those using more traditional vaccine technologies.

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2021-02-05 13:55:11Z
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