Covid-19 update: medicine regulator to assess the dose regimen for AstraZeneca vaccine

December 09, 2020 01:26 PM GMT | By Kunal Sawhney
 Covid-19 update: medicine regulator to assess the dose regimen for AstraZeneca vaccine

Summary

  • The vaccine displayed varying efficacy levels with different dosages
  • Initial AstraZeneca shots to come from Europe

The UK medical regulator would be examining the data from the clinical trials of the Covid-19 vaccine developed jointly by Oxford University and AstraZeneca. The body would be assessing which dosing regimen is best for usage, said June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA). This news came in after a study revealed that the particular vaccine had an efficacy level of 62 per cent for the trial participants who were administered 2 full doses, while it was 90 per cent for a smaller set of participants who were first given a half dose, followed by a full one.

It came as a surprise that the efficacy rate was higher when a low dose was followed by a higher one. The two doses of the vaccine candidate ChAdOx1 nCoV-19 or AZD1222 has a gap of 28 days between them. 

Raine emphasised that the MHRA would like to explore the reasons for different doses showing varied efficacy rates. “We will be looking at every piece of the evidence, including the basis of an appropriate regimen for the dosage”, she insisted.

(Image Source: ©Kalkine Group 2020)

An overall effectiveness of 70 per cent

The interim trial results for the AstraZeneca vaccine were published in the Lancet Journal around two weeks back. They said that the vaccine was safe, effective, and provided good protection with a lower efficacy level of 62 and a higher of 90 per cent, giving an overall effectiveness of 70 per cent.

These trials were carried out on over 20,000 people, most of whom were younger than 55. But the results so far did indicate that the vaccine worked well on the elderly too. Close to 1400 people received a half dose followed by a full later.

Initial shots to come from Europe

In a separate development, the UK’s vaccine taskforce revealed that the country’s initial doses of the AstraZeneca/Oxford would not be coming in from the domestic supply chain. Instead, they would be flown in from Europe.

The reason is that over 20 per cent of doses being produced by the UK-Swedish pharma major for the UK would be prepared in Europe. AstraZeneca has promised to supply 100 million doses to the nation, informed Ian McCubbin, manufacturing lead, UK Vaccine Taskforce. The vast majority of close to 80 per cent doses would be made domestically, but not the very first batch, added McCubbin.

The first batch would be coming in from Germany and the Netherlands, he added. All of this should be coming in by the end of this year, he further clarified.

 

Regulatory approvals soon

According to media reports, the regulatory approvals for this vaccine would be coming in within the next two weeks’ time. At the same time, questions do remain around the final data on the AstraZeneca/Oxford’s vaccine candidate which has shown varying efficacy levels between 62 and 90 per cent, which is being investigated by the MHRA.

Kate Bingham, chair, UK Vaccine Taskforce informed that the country would begin trials next year using a combination of various vaccines for initial and booster doses to attain the maximum possible immunity level.


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