The Oxford University/AstraZeneca vaccine has been approved by the UK medicines regulator, raising hopes that immunisation against Covid-19 could be increased within days, using a single jab in order to get as many vulnerable people protected as possible. The approval of the vaccine by the Medicines and Healthcare products Regulatory Authority (MHRA) after weeks of examining trial data was greeted with excitement and relief by experts. The Pfizer/BioNTech vaccine already in use needs to be stored at -70C and is hard to deploy. The Oxford vaccine, however, only needs normal refrigeration at 2-8C and is easily transported from UK factories, meaning it will not have to be kept in central hospital and community hubs, enabling a swift rollout to GP practices and care homes. The vaccination programme will start on 4 January and will aim to reach millions of people in at-risk categories as quickly as possible. The emergence of a new variant of the virus causing high rates of infection has made vaccination even more urgent. The Oxford vaccine’s ease of use means pharmacists will be able to administer the vaccine in chemist shops, as they do with flu immunisations. The Joint Committee on Vaccination and Immunisation (JCVI) has advised that the priority should be to give as many people as possible in at-risk groups their first dose of either the Oxford or the Pfizer vaccine, rather than providing two doses in four weeks in line with the protocol in the trials. “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,” a spokesperson for the Department of Health and Social Care (DHSC) said.. Amid the widespread praise for Oxford University and AstraZeneca in gaining UK approval for a vaccine that is vital to the global prospects of ending the pandemic because of its low cost and ease of use, some experts were anxious at the proposed mode of use. They said it was pragmatic to try to ensure as many people as possible had a first shot, giving them some protection, but that there were unanswered questions. These include the evidence for extending the time between injections to 12 weeks, which could lead to some people not returning for the second dose. Pfizer/BioNTech said categorically that their vaccine was not designed to be used in two shots 12 weeks apart, which the JCVI has now authorised in the UK. In a statement, the firms said there was no evidence the first shot continued to work beyond three weeks. “Data from the phase 3 study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95%. There are no data to demonstrate that protection after the first dose is sustained after 21 days,” they said. The decision to approve the Oxford/AstraZeneca vaccine followed “rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, the DHSC said. AstraZeneca said its vaccine would be made available to some of the poorest regions of the world at a low cost and was not being manufactured for profit. Talking to BBC Radio 4’s Today programme, its chief executive, Pascal Soriot, said the company could provide the UK with as many as 2m doses a week and would start shipping the first doses “today or tomorrow”. He said: “Vaccination will start next week and we will get to 1m a week, and beyond that a week, very rapidly. The good news with this is we are going to be able to inject a lot of people with one dose very quickly, provide them with a reasonably good dose of protection until they get their second dose two to three months later. That will enable us to protect many more people because we can wait two to three months for the second dose.” The UK has ordered 100m doses of the vaccine, which will eventually be offered to all adults, according to Matt Hancock, the UK health secretary. Speaking to BBC Breakfast, he said: “Because we’ve got enough of this vaccine on order to vaccinate the whole population – we’ve got 100m doses on order – add that to the 30m doses of Pfizer and that’s enough for two doses for the entire population. “So I can now say with confidence that we can vaccinate everyone, except of course for children because this vaccine has not been trialled on children, and anyway children are much, much less likely to have symptoms from the disease.” Boris Johnson described the vaccine’s approval as “truly fantastic news, and a triumph for British science”. He tweeted: “We will now move to vaccinate as many people as quickly as possible.” Appraisal of the Oxford vaccine has taken longer than it did for the Pfizer/BioNTech product, which the UK was the first country to approve on 2 December. The dossier of testing and trial results for the Oxford vaccine was more complicated. 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 62% efficacy in their largest trial, of 11,636 people, but 90% efficacy in a small additional sub-group in the UK numbering 2,741 who were given half a dose of the vaccine followed by a whole dose four weeks later. It is understood that people will be given a single standard dose, and not the half dose that appeared to give better protection in the trial sub-group. The MHRA in effect dismissed the finding from the trials that there was 90% efficacy in that subset, which was made up of fewer than 3,000 people in the UK, who were mostly under the age of 55, so was not typical of the population’s most vulnerable. However, the MHRA said it was not the age of the participants that caused the high efficacy rate. Instead, it suggested it may have been because there was a longer gap between the administration of the first and second doses of vaccine. More details of their assessment was to come, the authority said. Overall, the MHRA said, the efficacy of the vaccine was about 70%when given as a single standard dose. The second dose, not later than 12 weeks afterwards, was necessary because the effect may not last without the booster shot, it said. The MHRA acknowledged there was limited data on the effects of the vaccine in elderly people. Ongoing trials in the UK and US will supply more evidence, but it said it was satisfied the vaccine was safe and effective in the older population. The researchers have pointed out that none of the volunteers in the trials who had the vaccine became seriously ill or were admitted to hospital. Prof Andrew Pollard, the director of the Oxford Vaccine Group and the chief investigator of the Oxford trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants. “Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.” The Labour leader, Keir Starmer, tweeted: “We now need a national effort to get vaccinations delivered across the country.” Jonathan Ashworth, the shadow health secretary, welcomed the news, tweeting: “Now let’s go hell for leather to get jabs rolled out. We’ve seen how more virus circulating means opportunities for variants to emerge. This is now a race against time. We need vaccination ramped up especially for NHS staff urgently.” Johnson said the UK had already vaccinated more than 800,000 people with the Pfizer/BioNTech jab. Source
