The United Kingdom today became the first country to approve the AstraZeneca-Oxford COVID-19 vaccine for emergency use, and its vaccine advisory group also recommended spacing out doses of it and the Pfizer-BioNTech vaccine to allow greater numbers of high-risk people to be vaccinated.
The announcement comes on the 1-year anniversary of the first English language reports of an unexplained pneumonia outbreak in Wuhan, China, and as the UK battles a more transmissible variant of SARS-CoV-2 that was confirmed just a few weeks ago.
Vaccine approval came with strategy to expand reach
The AstraZeneca-Oxford vaccine is a viral-vector vaccine that can be kept at normal refrigeration temperatures, which will ease its rollout across a wide range of immunization settings, including lower-income countries and remote settings.
In a statement, UK health officials said they have accepted the advice of the Joint Committee on Vaccination and Immunization to prioritize the first doses for as many people as possible, given that both vaccines offer considerable protection after a single dose. The second dose, to be given 12 weeks later, is important for longer-term protection, and the longer delay between the two doses allows completion of the vaccine course over a longer timeframe.
Interim analysis suggests that the overall efficacy for the vaccine is 70.4%, the company said in a statement. It added that no cases of severe disease or hospitalization were seen in the vaccine group. The efficacy is lower than the 95% seen for the Pfizer-BioNTech vaccine. Single-dose efficacy was said to be 52.7%, according to Reuters, based on information from British officials.
UK officials also weighed in on pregnancy and breastfeeding issues, saying that vaccination with either vaccine in pregnancy should be considered when the risk of virus exposure is high and can't be avoided or if the mother has underlying health conditions. They also said breastfeeding women can be offered the vaccines following consideration of their clinical need for immunization.
The approval allows the first doses to be released today and paves the way for vaccinations to begin in the UK early in the new year, the company said. It has a contract with the government to supply as many as 100 million doses in the first quarter of 2021.
Though the UK approval is the first for the vaccine, its action today speeds the momentum for faster approval elsewhere. The AstraZeneca-Oxford vaccine is a key part of the World Health Organization (WHO)-led COVAX plan to ensure equitable access for lower-income countries. It recently announced an advance purchase agreement for 170 million doses of the vaccine.
A dose error in the AstraZeneca-Oxford phase 3 trial, in which some were given a half-dose for their first dose, has muddied the trial findings, though the UK pushed forward with its temporary approval.
At an Operation Warp Speed briefing today, Moncef Slaoui, PhD, the group's chief scientific advisor, said British officials used science-based, skilled methods in reaching their decision, but he said some questions still remain about the vaccine, such as efficacy in seniors, who made up a relatively small proportion of the study group, and persistence of protection. He said it's important to use the vaccine as it was studied, but he also noted that it's important to have in mind the level of transmission.
Slaoui also said that though he wasn't criticizing the UK's process, it's critical to have clear and concrete numbers about efficacy rather than those from accumulated data from different trials and vaccine schedules.
UK adds more of country to highest restriction tier
With cases soaring and a more transmissible SARS-CoV-2 variant circulating, the UK government announced that more of the country will be put on tier 4 restrictions starting tomorrow, according to the BBC.
The action puts 20 million more people under the toughest measures to curb the spread of the virus and applies to the Midlands, the North East, and parts of the North West and the South West. Officials also said secondary schools will be closed for 2 more weeks.
The UK reported 50,023 new cases today, along 981 more deaths, according to a statement from Public Health England. Yvonne Doyle, MD, MPH, PHE's medical director, said the country now has two licensed vaccines and that hope is on the way. "But it is crucial that people keep their contacts to an absolute minimum to help drive down infections," she said.
In other global headlines:
- China's state-owned Sinopharm reported that its COVID-19 vaccine is 79.34% effective, based on phase 3 findings in people who received two doses, according to CNN, which cited a statement posted on a company subsidiary website. The company has two vaccines, and it's not clear which vaccine had the high efficacy.
- Taiwan today reported its first detection of the UK SARS-CoV-2 variant, which involves a returning traveler whose illness was confirmed earlier, according to Reuters. Also, the United Arab Emirates reported a limited number of variant cases in returning travelers, though it didn't specify which variants, according to CNN.
- The WHO's African regional office today urged countries to step up their surveillance as new variants circulate, which is occurring amid a rise in cases in the region that has nearly reached the peak seen in July. The highest numbers of new cases are from Algeria, Botswana, Burkina Faso, Democratic Republic of the Congo, Ethiopia, Kenya, Namibia, Nigeria, South Africa, and Uganda.
- The global today is now at 82,456,204 cases, with 1,799,493 deaths, according to the Johns Hopkins online dashboard.
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December 31, 2020 at 04:43AM
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UK becomes first country to green light AstraZeneca-Oxford vaccine - CIDRAP
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