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The Oxford AstraZeneca Covid vaccine is 90% effective in a small group that received half the dose first, but only 62% in the majority, as confirmed by full trial data recently published in The Lancet.
The results can create a dilemma for regulators, who will have to decide how the vaccine should be used if they approve it.
The University of Oxford and its partner, AstraZeneca, are seeking regulatory approval for their long-awaited vaccine on the grounds that it is 70% effective after combining the results of trials in the UK and Brazil.
But it’s the individual regulatory bodies in the UK, Europe, and the US that will have to decide which dosage regimen is appropriate if they authorize it.
Fast guide
When and how will I be able to get the Covid vaccine in the UK?
Now that the UK has authorized the first Covid vaccine, who will get it first?
The government’s Joint Committee on Vaccination and Immunization (JCVI) says its priority is to prevent Covid-related deaths and protect health and social care personnel and systems.
Nursing home residents and their caregivers are first on the JCVI list because their risk of exposure to the virus is higher and because the risk of death is closely correlated with advancing age. They are followed as a priority by any other person over the age of 80 and front-line health and social care workers.
Still, for pragmatic reasons, NHS staff are likely to be the first group to take the Pfizer / BioNTech hit. This is because the vaccine must be stored at extremely cold temperatures, which can be more easily achieved using hospital facilities.
Are there enough doses to reach all priority groups?
Together, nursing home residents, their caregivers and those over 80 years old number nearly 6 million people, and frontline NHS staff 736,685 more. Matt Hancock, the health secretary, has said that he expects 10 million doses of the Pfizer / BioNTech vaccine to be available this year, so if this is the only licensed vaccine, everyone else would have to wait until there are more doses. available next year.
Where will I go for the vaccine?
Covid-19 vaccines are expected to be delivered to three types of locations: trusted NHS “vaccine centers” in hospitals; mass vaccination centers, which are being installed in places like football stadiums, conference buildings and racetracks; up to 5,000 people a day are expected to be vaccinated; and in general practitioners and pharmacies. GPs are also able to visit nursing home residents and homebound patients without travel.
How far apart will the two doses be administered and will I be protected after the first?
While there is some evidence indicating high levels of short-term protection with a single dose of vaccine, a two-dose schedule is what has been approved by the MHRA.
The second dose should be given at least 21 days after the first, and both will be injected into the deltoid muscle, the thick triangular muscle that we use to lift each arm.
For the Pfizer vaccine, its efficacy rate was calculated seven days after the second injection. People will likely have some protection before this, but this is how long it will take for full protection to kick in. We will learn more about the scope of protection and how long it lasts as data from ongoing clinical trials arrives.
Can I pay for the vaccine privately?
Unlikely. England’s Deputy Chief Medical Officer Jonathan Van-Tam has said he believes Covid-19 vaccines should be given according to clinical priority rather than allowing people to skip the queue if they can afford them.
Will I be able to choose which vaccine I have?
It is also unlikely, at least in the short to medium term. Assuming more than one vaccine is approved, the priority will be to distribute the available doses to people who need them as quickly as possible.
Linda Geddes
“Our job as scientists is to generate the data and make it available to the public for people to scrutinize and scientists to scrutinize and also now for regulators and lawmakers to scrutinize. These decisions are not for us, ”said Professor Andrew Pollard of the University of Oxford, lead investigator of the trials.
The UK’s Medicines and Healthcare Products Regulatory Authority (MHRA), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) may reach different conclusions.
The FDA is unlikely to approve the vaccine as quickly as the UK and Europe. It has also expressed concern about the limited data on ethnicity in the trials and the absence of older people at higher risk, as most of the participants were under 55 years of age. A large trial is being carried out in the country in which 20% are older people and there is a greater ethnic representation. US.
“We will submit the data to the FDA, but our best guess is that we will need to read the study from the US before we can get approval in the US,” said Mene Pangalos, Executive Vice President of R&D. of biopharmaceuticals at AstraZeneca.
Publication of the full trial data in the Lancet medical journal will be welcomed worldwide.
Oxford AstraZeneca is considered the most important vaccine worldwide because it is easy to manufacture and distribute at refrigerator temperature, and the cost is low. AstraZeneca has committed to manufacturing 3 billion doses and is part of Covax, the UN program to distribute vaccines to every country in the world.
Speaking of how the first people in the UK received the first approved vaccine, from Pfizer / BioNTech, Pascal Soriot, CEO of AstraZeneca, said it was important to have several. “In fact, if you add the capacity, at least the advertised capacity, of Pfizer, Moderna and ours, there is still not enough to vaccinate a sufficient number of people around the world,” Soriot said.
“We need all the vaccines. So that’s really an important point to keep in mind when people start comparing data across various studies. We need all this capacity, we need all these vaccines, to help tackle the pandemic as quickly as possible. “
The AstraZeneca vaccine is expected to be the mainstay of the UK vaccination program. The UK has ordered doses of 100 million; 4 million are already in the country.
The researchers say they agreed with the regulator to pool the results of the different dosing trials after a small subset inadvertently received a low starting dose. The expectation was that two full doses would work best.
Efficacy data is based on 11,636 volunteers in the UK and Brazil. Only 2,741 people in the subgroup received a first low dose, half of whom received the vaccine and the other half a placebo. But the efficacy in that group was 90% compared to 62% among the rest.
But the researchers say it makes sense to pool the results. “There is enough consistency to justify the proposed joint data analysis, which will provide greater precision for efficacy and safety results than can be achieved in individual studies and provide a broader understanding of the use of the vaccine in different populations,” they to write.
The Lancet publication includes comprehensive safety data from volunteers in those two countries and also in South Africa, where efficacy results are not yet available. Out of a total of more than 23,000 trial volunteers, only three of the 175 reported serious adverse events were possibly related to the vaccine.
