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UPDATE: AZ/Oxford University COVID-19 vaccine gets EU approval

MHRA is looking "very closely" at reports of adverse reactions to coronavirus vaccines

UPDATE: MHRA is looking "very closely" at reports of adverse reactions to coronavirus vaccines

Vaccines minister Nadhim Zahawi has said that the UK's medicines regulator is looking "very closely" at reports of adverse reactions to coronavirus jabs,

According to the Medicines and Healthcare products Regulatory Agency (MHRA), out of 18.1 million doses of the Oxford-AstraZeneca vaccine that have been administered up to and including 24 March, it has identified 30 cases of rare blood clot events. Among these 30 cases there have been seven deaths.

The MHRA is continuing to urge the public to get the vaccine when they are invited to do so, and has reiterated that the benefits of the vaccine in preventing coronavirus outweigh any risks.

Zahawi told BBC Breakfast: "The regulators absolutely look at, very closely, any adverse incidents through the yellow card system.

"And June Raine, who is the chief executive of the MHRA, our independent regulator, said last night that if you get the invite for the vaccine, to take that invitation and get the vaccine and get protected.

"At the same time, they are looking at these very rare instances of blood clotting.

"To put it in perspective, we have done almost 20 million vaccinations using the Oxford-AstraZeneca vaccine.

"Both vaccines [the other being Pfizer] have saved something like 6,300 lives between December and the end of February, so it's important to continue to follow what the clinicians, the scientists, the regulators tell us.

"And we will absolutely do exactly as they say."

1 February 2021: The European Commission (EC) has granted AstraZeneca (AZ) and Oxford University’s COVID-19 vaccine a conditional marketing authorisation (CMA) for use in people aged 18 years and older.

The European Medicines Agency (EMA) recommended the CMA on Friday, following an assessment conducted by its Committee for Medicinal Products for Human Use (CHMP) of all the available safety and efficacy data for the vaccine.

This included results from four clinical trials in the UK, Brazil and South Africa, which involved approximately 24,000 people in total.

However, the EMA focused on the efficacy observed in results from the studies based in the UK and Brazil, as the other two studies had fewer that six COVID-19 cases each.

The agency also concentrated on results involving people who had received a two-dose regimen of the vaccine, given between four to 12 weeks apart.

According to the EMA, these results showed a 59.5% reduction in the number of symptomatic COVID-19 cases for those who received the vaccine, compared to those who received a placebo – reflecting a 60% efficacy for the jab.

The EMA also noted that although there are not enough results in older participants (over the age of 55) to determine how well the AZ/Oxford vaccine works in this group, protection against COVID-19 in this population is still ‘expected’.

Last week, German media reports suggested that the AZ/Oxford vaccine is less effective in people over the age of 65.

The German newspapers Handelsblatt and Bild separately reported that the AZ/Oxford vaccine had an efficacy of only 8% or less than 10% in individuals aged 65 years and over. In response, AZ said that the reports were “completely incorrect”.

AZ and the EU have also been involved in a dispute over the committed doses of its vaccine, after AZ said that it would reduce initial deliveries of the jab to the EU by 60% in the first quarter of 2021.

European Commission president Ursula von der Leyen announced yesterday that AZ will deliver nine million additional doses of the vaccine in the first quarter, with 40 million doses in total now expected to be delivered in this timeframe.

The EU announced last week that it would impose export controls on COVID-19 vaccines manufactured in the EU, attempting to place measures on the Irish border.

However, the EU has since reversed these efforts, with von der Leyen disclosing that "there will be no disruption of contracts that we have with any producer in the EU".

Article by
Lucy Parsons

12th April 2021

From: Regulatory



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