Vaccine approvals add promise for COVAX use

Britain and Argentina became the first nations on Wednesday to authorize emergency use of the coronavirus vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca, adding momentum to its anticipated global use by international organizations.

The vaccine gained its first approval in the United Kingdom. Later in the day, Argentina became the second nation to sign off. Both countries granted permission for the vaccine to be put to emergency use, based on a calculation that it is safe enough for the public and the risks outweigh the benfits.

Unlike the two-shot vaccines from BioNTech and Pfizer and from Moderna that require ultracold freezers to remain effective and cost governments in the US$20 to $40 range, the Oxford-AstraZeneca vaccine can be stored and shipped at normal refrigeration temperatures for six months and costs less than US$4 per dose.

That makes it a better fit for use by the Access to Covid-19 Tools (ACT) Accelerator, a global collaboration among 10 international organizations to provide coronavirus tests, medicines and vaccines worldwide, since the Oxford-AstraZeneca vaccine is easier to ship to poor nations with more difficult access and is relatively cheap to produce.

The ACT-Accelerator includes the COVAX Facility — an ambitious effort to accelerate COVID-19 vaccines and to guarantee all nations will have fair and equitable access to them — that is co-led by the World Health Organization; Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations.

COVAX says its goal is to deliver 2 billion doses of safe, effective vaccines "that have passed regulatory approval and/or WHO pre-qualification" by the end of 2021. That includes delivering at least 1.3 billion donor-funded doses of approved vaccines in 2021 to the 92 low- and middle-income economies eligible for COVAX.

The U.N. health agency usually evaluates vaccines after national regulators clear them so the shots will be "pre-qualified" for donors to buy for developing nations, but it does not license or regulate the vaccines itself.

"These vaccines will be offered equally to all participating countries, proportional to their populations, initially prioritizing health care workers then expanding to cover vulnerable groups, such as the elderly and those with pre-existing conditions," the organizations said in a joint statement earlier this month.

"Further doses will then be made available based on country need, vulnerability and COVID-19 threat," they said. "The COVAX Facility will also maintain a buffer of doses for emergency and humanitarian use."

'Acceptable benefit-risk'

Though the Oxford-AstraZeneca vaccine was 90% effective in a small group given a half-strength initial dose, it was found to be 62% effective in clinical trials when given in two, full-strength doses — about a third less effective than the roughly 95% efficacy with the Pfizer-BioNTech and Moderna double shots.

The United Kingdom's Department of Health and Social Care, which previously approved the Pfizer-BioNTech shot for emergency use in early December, said its second approved vaccine against COVID-19 will nonetheless greatly expand the nation's immunization program with hundreds more vaccination sites.

"The vaccine is highly effective in preventing disease, including in the elderly, and vaccinations will begin from next week," the government agency said in a statement. Britain had signed the first purchase agreement with Oxford University and AstraZeneca, securing the nation's access to 100 million doses of the vaccine.

Argentina's health regulator, ANMAT, said in a statement the vaccine "presents an acceptable benefit-risk balance" that makes it permissible for use for one year, on the condition a medical prescription is obtained. The nation and Mexico have agreed to produce an initial 150 million to 250 million shots of the vaccine for Latin American countries.

Hundreds of thousands of doses will be available in Britain starting next Monday, the U.K. department said, and more are to be delivered over the coming weeks and months.

COVAX has signed an advance purchase agreement with AstraZeneca for 170 million doses of its vaccine, and it also has an agreement with the Serum Institute of India for 200 million doses — and options for up to 900 million doses more — of either the Oxford-AstraZeneca or another vaccine candidate. Most of the vaccines are being given in two doses, about three weeks apart.

AstraZeneca, in turn, contracted the Serum Institute of India to make 1 billion doses, but only about 50 million had been produced as of early December. The drug maker also plans to use other manufacturers in Brazil, China and South Africa to provide its shots for use in developing nations.

U.K. Health and Social Care Secretary Matt Hancock said the Oxford-AstraZeneca vaccine "will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease."