According to a Guardian report, the Oxford vaccine rollout plan has been changed over concerns regarding giving millions the first jab with a wait of up to 12 weeks for the second dose.
- The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday.
- There will be 530,000 doses available from next week, and vaccination centres will now start inviting patients to come and get the jab.
- Priority groups for immunisation have already been identified, starting with care home residents, the over-80s, and health and care workers.
- The UK has ordered 100 million doses of the new vaccine – enough to vaccinate 50 million people.
- Eventually all over 50s and younger adults with health conditions will be offered a jab in the first phase of the rollout – more than 25 million people in total.
- It is hoped that about two million patients a week could soon be vaccinated with two vaccines now approved.
- The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised two full doses of the Oxford vaccine, with the second dose to be given four to 12 weeks after the first.
- The immunisation campaign will now shift to giving as many people as possible their first dose of vaccine with a second dose following within that period.
- The Oxford vaccine is easier to store and distribute, as it can be kept at normal fridge temperature unlike the Pfizer-BioNTech jab that has to be kept at -70C.
- There is also more confidence about supply as it is UK-made, whereas the Pfizer-BioNTech jab has to be shipped in from Belgium.
Single Shot Booster Jab
Millions of people across the UK at risk from Covid will be offered a single first dose of the Oxford/AstraZeneca vaccine, with a booster jab within three months, in a bid to return the country to some normality by the spring, the prime minister has said.
When the Pfizer-BioNTech jab rollout began, the aim was to give the second dose after three weeks.
But based on advice from the Joint Committee on Vaccination and Immunisation, the aim now is to give as many vulnerable people some protection from Covid-19, irrespective of the jab they are given.
Rollout of the Oxford vaccine will begin on 4 January following its approval for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA).
- The government hopes the vaccine, of which it has ordered 100m doses, will transform prospects in the UK and check the spread of the rampaging coronavirus variant which has caused cases to surge.
- Pharmacies as well as GPs will be able to give the jabs to those at risk.
Pregnant and breastfeeding women can now take either of the two approved coronavirus vaccines “when the potential benefits outweigh the risks”, experts said at an MHRA news conference.
The Pfizer/BioNTech vaccine can also now be administered to people with a wide range of food and medicine allergies, but people allergic to ingredients in the vaccine should not take it.
Dr June Raine, chief executive of the MHRA, told the briefing that “no corners have been cut” in assessing the safety and effectiveness of the Oxford-AstraZeneca jab.
Relying on the Time Gap
But the MHRA and the government’s advisory Joint Committee on Vaccinations and Immunisation delivered a surprise by announcing approval of a regime that was not trialled. Both the Oxford vaccine and the Pfizer/BioNTech jab which is already in use will be given to people as one shot, followed by another up to 12 weeks later, in order to extend some protection to as many people as possible as quickly as possible.
Boris Johnson said at a Downing Street press conference that the benefits from the vaccine would kick in within 21 days. “What that means is we can vaccinate and protect many more people in the coming weeks,” he said.
Restrictions To Be Lifted By Spring?
He hoped that by spring of 2021, many coronavirus restrictions would be able to be lifted. “If we’re right and the vaccination programme does have the positive effects that we think it can have, and I stress these are ifs, then clearly a lot of the non-pharmaceutical interventions … will recede into the past,” he said. “We’ll be able to do things very differently.”
The prime minister added that the public may need to carry on with “basic disciplines” such as washing hands and wearing masks “for a while after”.
Experts Back the Approval
The approval of the vaccine by the 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 in the long-term at -70C and is hard to deploy. The Oxford vaccine, however, can be kept in a normal fridge 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.
Experts Apprehensive of the Mode of Use
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 normal refrigeration, 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 that their vaccine was not designed to be used in two shots 12 weeks apart. 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’s Goal
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.”
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.”
Government Backing the 12 Weeks Gap Strategy
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.
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 reached about 70% between three weeks and 12 weeks, 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.
No Serious Side Effects
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.
Did you subscribe to our daily newsletter?
It’s Free! Click here to Subscribe!
