The Oxford University / AstraZeneca vaccine has been approved by the UK medicines regulator, raising hopes that the vaccine will be rapidly increased against Covid-19 within days, using just one view so that so many people can -protection of injured.
Regulatory experts welcomed the vaccine by the Medicines and Healthcare products Regulatory Authority (MHRA) after weeks of testing the trial data. The currently used Pfizer / BioNTech vaccine needs to be stored at -70C and is difficult to use. As the Oxford vaccine only requires normal cooling at 2-8C and is easily transported from UK factories, it will no longer be required in major hospitals and community centers, including distribution to GP practices and care homes quickly.
The vaccination program begins on Monday 4 January and aims to reach millions of people in at-risk regions as soon as possible. The new strain of the virus that causes high levels of infections has made vaccination much more urgent.
The government’s joint committee on immunization and vaccination (JCVI) has advised that giving the first dose of Oxford or Pfizer vaccine to as many people in at-risk groups as a priority should be a priority, rather than giving two doses in four weeks according to the protocol in the trials.
“Everyone will still receive their second dose and this will be within 12 weeks of the first day. The second dose completes the course and is important for long-term protection, ”said a spokesman for the Department of Health and Social Care (DHSC).
The decision to approve the vaccine resulted in “rigorous clinical trials and a detailed analysis of the data by experts at MHRA, who have concluded that the vaccine has met the strict standards of safety, quality and efficacy” , the DHSC said.
AstraZeneca said its vaccine would be available to some of the poorest areas of the world at a low cost and not manufactured for profit.
Speaking to BBC Radio 4’s Today program, its boss, Pascal Soriot, said AstraZeneca could deliver up to 2m doses a week to the UK and start delivering the first doses “today or tomorrow ”.
He said: “Vaccination will start next week and will reach 1m a week and beyond a week very quickly. ”
He said: “The good news with this is that we are able to introduce many single-dose people quickly, giving them a good protective dose until they get their second dose two or three months later. sin. That will allow us to protect many more people as we can wait two or three months for the second dose. “
The UK has ordered 100m doses of the new injection and will eventually offer the vaccine to all adults, according to Matt Hancock, the UK health secretary.
Speaking to BBC Breakfast, he said: “Because we have enough of this vaccine to give the vaccine to the whole population – we have 100m doses on prescription – add that to the 30m doses of Pfizer and that’s enough for two doses for the whole population.
“So I can confidently say that we can vaccinate everyone, except children because this vaccine has not been tried on children, and at least children are much, much more prone to symptoms. from getting the disease. “
The prime minister, Boris Johnson, described the news as “truly exceptional news – and a boon to British science”.
He tweeted: “We will now move to vaccinate as many people as soon as possible. ”
An evaluation of the Oxford vaccine took longer than it did for the Pfizer / BioNTech vaccine, which was approved by the UK faster than any other regulator in the world on 2 December. The file of test and test results for the Oxford vaccine is more complex.
Pfizer / BioNTech, whose vaccine is based on novel mRNA technology, had clear results, with 95% efficacy from a single international trial involving 43,000 people.
Oxford / AstraZeneca had a 62% efficacy in their largest trial, of 11,636 people, but 90% efficacy in a further small subgroup in the UK with 2,741 receiving half a dose of the vaccine, followed by a total dose four weeks later after that.
It has not yet been said whether full or half doses will be the first sight given to millions.
The researchers have stated that none of the volunteers in the trials received the vaccination ill or were admitted to the hospital.
Trials of the vaccine are still ongoing to collect more data. AstraZeneca is running a major test in the U.S. and the U.S. regulator, the Food and Drug Administration, is not expected to approve the vaccine until it is ready. The FDA has also sought more data on the protection afforded to the elderly and black and minority ethnic vaccines by the vaccine.
Professor Andrew Pollard, director of the Oxford Vaccine Group and lead examiner of the Oxford trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a real moment, and a testament to the great effort of Enthusiastic national team of researchers and our dedicated test partners.
“While this is only the beginning, we will begin to tackle the pandemic, protecting health and the economy as vulnerable people are vaccinated everywhere, as soon as possible. possible. ”
Labor leader Keir Starmer tweeted: We now need a national effort to roll out vaccines across the country. ”
Jonathan Ashworth, shadow health secretary, welcomed the news, tweeting: “Now let’s go to hell for leather to take out jabs. We have seen how more viruses circulate means opportunities for change to emerge. This is now a race against time. We need to get vaccinated, especially for NHS workers in emergencies. ”
According to the Prime Minister, the UK has already vaccinated more than 800,000 people with Pfizer / BioNTech injections.