Business

UK drugs watchdog approves Oxford/AstraZeneca Covid vaccine

The UK drugs watchdog has approved the coronavirus vaccine made by Oxford university and AstraZeneca, boosting hopes that millions more Britons can be inoculated against the disease in the coming months as a new viral variant takes hold.

AstraZeneca said on Wednesday the UK Medicines and Healthcare products Regulatory Agency had given the jab an emergency authorisation, allowing it to be rushed to patients and offering renewed hope of taming the pandemic as the number of patients with Covid-19 in English hospitals reaches an all-time high.

The UK, the EU and the US have respectively placed orders for 100m, 400m and 300m doses of the vaccine developed by Oxford and licensed to the Anglo-Swedish drugmaker.

The vaccine requires long-term cold storage of between 2 to 8 degrees Celsius, or the temperature of a conventional fridge, making it easier to store and distribute than those made by rivals.

The requirement that the BioNTech/Pfizer vaccine, which has been at the centre of the UK’s mass vaccination campaign that began on December 8, is stored at minus 70C has prevented many GPs around the country from participating in the programme. The Oxford vaccine is not only easier to store but may not require that people are monitored for 15 minutes after receiving the shot, making less burdensome social distancing demands.

The easier cold chain requirements, coupled with at-cost pricing during the pandemic, have made it an attractive option for a number of countries. Supply deals indicate a single dose of the vaccine is priced at about $3 to $4. AstraZeneca has pledged to sell the vaccine at cost to developing nations in perpetuity after Oxford insisted on access conditions.

The MHRA approved a dosing regimen, with two doses at an interval of between four and 12 weeks, that AstraZeneca has said it believes will prove highly effective against the disease. In trials it proved 100 per cent successful in preventing severe disease.

The UK regulator has also confirmed that doses can be given up to three months apart, which could allow far more Britons to be vaccinated quickly, without the need to hold back any of the current supply, because there would be time to manufacture additional volumes.

AstraZeneca said the jab had been given emergency authorisation and that the first doses would be released on Wednesday, so that vaccinations could begin early in 2021.

The health and social care department said: “Throughout this global pandemic we have always been guided by the latest scientific advice. Having studied evidence on both the BioNTech/Pfizer and Oxford university/AstraZeneca vaccines, the [Joint Committee on Vaccination and Immunisation] has advised the priority should be to give as many people in at-risk groups their first dose, 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,” it added.

The UK has placed forward orders for a total of 357m doses coronavirus vaccine from a variety of companies. Several have yet to complete late-stage trials.

The announcement in November that the Oxford/AZ vaccine had successfully completed clinical trials was shrouded in controversy after it emerged that the regimen that produced the best results — around 90 per cent efficacy — had not been tested in people older than 55, the group at highest risk from the disease.

When only all-age data was considered, the vaccine was 62 per cent effective — substantially below BioNTech and Moderna vaccines, both of which hit the mid-90s.

The UK’s approval of the Oxford vaccine comes ahead of nods expected from US and EU regulators.

However, the European Medicines Agency will not assess the vaccine until at least next month, as it has not yet received an application from the drugmaker, it confirmed on Tuesday.

US regulators are waiting for a late-stage trial to end before assessing the vaccine.


Source link

Related Articles

Back to top button