U.K. Authorizes AstraZeneca-Oxford Covid-19 Vaccine

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U.K. Authorizes AstraZeneca-Oxford Covid-19 Vaccine

Researchers at work on the Covid-19 vaccine in a laboratory in Oxford, England.

Photo: John Cairns/Associated Press

LONDON—The U.K. authorized a Covid-19 vaccine developed by the University of Oxford and AstraZeneca PLC, opening the door for the rollout of millions of doses in a country where infections have surged amid a more infectious variant of the virus.

U.K. health officials also recommended a delay of up to three months between both doses of the vaccine, guidance that also applies to the shot developed by Pfizer Inc. and BioNTech SE that was authorized in the U.K. earlier this month. The delay will allow inoculations to reach more people more quickly as the new variant pushes new cases to records and hospitalizations soar.

The green light represents the third emergency-use approval of a Western-developed vaccine this month and comes as cases are rising sharply in Europe and the U.S., which has now reported its first case of the new variant. The Pfizer-BioNTech shot and one developed by Moderna Inc. have been cleared in the U.S.

The Oxford-AstraZeneca vaccine stands out on price, convenience and global ambition. AstraZeneca has promised to make as many as three billion doses available in 2021—more than any other Covid-19 vaccine maker—and at a cheaper price. The U.K. company says it won’t profit from the shot during the pandemic, or ever in the case of poorer countries. The vaccine also can be transported and stored for months with normal refrigeration, making it easier to distribute where people and health-care networks are sparse or underfunded. The two other Western vaccines in use require ultracold temperatures for all but a few days or weeks.

AstraZeneca’s shot—less effective in clinical trials than its rivals’ injections—won’t be available in the U.S. until the Food and Drug Administration reviews large-scale trials still being conducted there and decides whether to authorize its use.

The mutated virus recently triggered travel bans from some nations on visitors and goods from Britain, ratcheting up the political urgency for a speedy vaccine rollout here. The government has said that more than 600,000 doses of the Pfizer-BioNTech vaccine have been administered.

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Dose Destinations

The Covid-19 vaccine developed by the University of Oxford and AstraZeneca is being counted on to help expand inoculations in the developing world.

Countries with advance commitments for the vaccine

(2.7 billion doses worldwide)

Countries with advance commitments for the vaccine

(2.7 billion doses worldwide)

Countries with advance commitments for the vaccine

(2.7 billion doses worldwide)

Countries with advance commitments for the vaccine

(2.7 billion doses worldwide)

Scientists have said that the three Covid-19 vaccines authorized by Western countries so far should be similarly effective against the new variant as they have been in clinical trials, a view AstraZeneca executives share, according to a person familiar with the matter. The new variant could be as much as 70% more transmissible than more established forms of Covid-19, government officials say.

The U.K. medicines regulator said the vaccine can be administered to people 18 years and older. The authorization clears the use of two standard vaccine doses, a regimen that was 62% effective in preventing symptomatic Covid-19 in an interim analysis of trials involving about 11,600 people in the U.K. and Brazil.

In the same study, a small subset of volunteers of age 55 and younger were given a half-dose shot followed by a standard dose. That subset showed a higher protection rate of 90%. The U.K. government hasn’t authorized the use of the half-dose regimen.

“We felt the results were not borne out by the full analysis,” Munir Pirmohamed, a pharmacologist who chairs the government’s advisory group that advised on the regulator’s recommendations, said in a media briefing Wednesday.

U.K. officials said they authorized the vaccine Tuesday and released the first batches that night.

As drugmakers distribute Covid-19 vaccines, cybersecurity experts are warning against the growing threat of tampering and theft by organized crime networks. WSJ explains how hackers are targeting the vaccine rollout during the pandemic. Illustration: George Downs

They advised that no preference generally should be given between the two vaccines so far authorized by the U.K. The higher efficacy shown by the Pfizer vaccine isn’t directly comparable with that of the Oxford-AstraZeneca shot, officials said, because of scientific and clinical-trial differences.

AstraZeneca and U.K. health officials said the two-dose regimen is flexible in terms of when the second dose should be given, anywhere from four weeks to 12 weeks after the first dose.

Delaying the second dose would help stretch supplies of the vaccine so more Britons get a first shot sooner. But the vaccine’s full protection—benefits shown in clinical trials to prevent hospitalization—only kicks in after the second dose.

U.K. health officials said Wednesday the updated second-dose guidance also applies to the Pfizer-BioNTech shot already being administered in the country. Previously, the second dose was recommended 21 days after the first. U.K. officials on Wednesday changed that to “within 12 weeks,” saying the change was based on the latest scientific advice. The vaccine’s makers have said full protection doesn’t start until at least seven days after the second dose.

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How Viral Vector Vaccines Work

AstraZeneca’s new vaccine relies on a different mechanism for conferring immunity than traditional vaccines.

Traditional Vaccines

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that are adapted to recognize the virus

2. After vaccination, the antibodies remain in the body. If the patient later becomes infected with the actual virus, the antibodies can identify and help neutralize it.

Weakened virus vaccine

Actual viral infection

antibodies

New Vaccine

Scientists have isolated genes in the new coronavirus responsible for producing these spike proteins. The genes are spliced into weakened, harmless versions of other viruses.

Instead of using the whole virus to generate an immune response, the vaccine relies on coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Weakened virus with

spike protein genes

Spike

proteins

When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus spike proteins.

Once exported from the cells, the spike proteins prompt the immune system to mount a defense, just as with traditional vaccines.

Spike protein

Vaccine-generated antibody response

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that are adapted to recognize the virus

2. After vaccination, the antibodies remain in the body. If the patient later becomes infected with the actual virus, the antibodies can identify and help neutralize it.

Weakened virus vaccine

Actual viral infection

antibodies

New Vaccine

Scientists have isolated genes in the new coronavirus responsible for producing these spike proteins. The genes are spliced into weakened, harmless versions of other viruses.

Instead of using the whole virus to generate an immune response, the vaccine relies on coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Weakened virus with

spike protein genes

Spike

proteins

When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus spike proteins.

Once exported from the cells, the spike proteins prompt the immune system to mount a defense, just as with traditional vaccines.

Spike protein

Vaccine-generated antibody response

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that are adapted to recognize the virus

2. After vaccination, the antibodies remain in the body. If the patient later becomes infected with the actual virus, the antibodies can identify and help neutralize it.

Weakened virus vaccine

Actual viral infection

antibodies

New Vaccine

Scientists have isolated genes in the new coronavirus responsible for producing these spike proteins. The genes are spliced into weakened, harmless versions of other viruses.

Instead of using the whole virus to generate an immune response, the vaccine relies on coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Weakened virus with

spike protein genes

Spike

proteins

When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus spike proteins.

Once exported from the cells, the spike proteins prompt the immune system to mount a defense, just as with traditional vaccines.

Spike protein

Vaccine-generated antibody response

1. In classic vaccines, such as those against measles and polio, the patient is inoculated with weakened or inactivated versions of the virus. This triggers the immune system to produce specialized antibodies that are adapted to recognize the virus

Weakened virus vaccine

antibodies

Actual viral infection

2. After vaccination, the antibodies remain in the body. If the patient later becomes infected with the actual virus, the antibodies can identify and help neutralize it.

New Vaccine

Instead of using the whole virus to generate an immune response, the vaccine relies on coronavirus’s outer spike proteins, which are what antibodies use to recognize the virus.

Spike proteins

Scientists have isolated genes in the new coronavirus responsible for producing these

spike proteins. The genes are spliced into weakened, harmless versions of other viruses.

Weakened virus with

spike protein genes

When injected into a patient, the genetically engineered viruses enter healthy cells where they produce coronavirus spike proteins.

Spike protein

Once exported from the cells, the spike proteins prompt the immune system to mount a defense, just as with traditional vaccines.

Vaccine-generated antibody response

Pfizer has promised the U.K. millions more doses by the end of the year, but the AstraZeneca and Oxford shot—made at facilities in the country and elsewhere—promises to quicken the rate of inoculations by the country’s state-run health-care system. The National Health Service will determine which shot to provide people depending on supply.

AstraZeneca said Wednesday it will supply millions of doses in the first quarter of next year, without specifying an exact number. The U.K. has ordered up to 100 million doses of the vaccine, enough for 50 million people.

Government advisers behind the authorization said the 90% efficacy shown in the half-dose regimen might have been caused by the longer period between the first and second doses in that trial subgroup, rather than the half-dose itself. They said the analysis of the half-dose subgroup helped lead to the U.K. government’s decision to recommend up to 12 weeks between doses.

The advisers said for the full-dose regimen, immunity kicks in roughly three weeks after the first dose. They estimated 70% effectiveness in the vaccine during the period from three weeks after the first dose, through the next three months. They said it isn’t clear whether that number will hold up in fuller clinical trials.

It is unclear how quickly other nations might authorize the vaccine. A large clinical trial is under way in the U.S., where AstraZeneca executives expect to have full trial data to submit by February, according to a person familiar with the matter. They have been submitting batches of data to European regulators and are poised for potential authorization across the European Union by February, the person said.

Oxford and AstraZeneca emerged early this year as front-runners in the race to develop a Covid-19 vaccine before falling behind competitors that were able to complete clinical trials faster. Developed by scientists at Oxford’s Jenner Institute, the vaccine uses a weakened cold virus to courier genetic material from the coronavirus into cells and trigger immunity.

AstraZeneca agreed in April to co-develop Oxford’s technology and distribute it around the world at no profit during the pandemic. By November, the company had agreements to supply three billion doses to every region in the world.

The partners have faced setbacks along the way to Wednesday’s milestone. In May, they launched a combined Phase 2 and 3 clinical trial in the U.K. aimed at enrolling more than 10,000 volunteers and obtaining initial results by August. But the study progressed slower than hoped for initially, partly because of relatively low infection rates in the U.K. for much of the summer and fall.

By the time AstraZeneca launched a planned Phase 3 U.S. study of 30,000 volunteers in late August, the company was trailing behind Pfizer and Moderna, which had begun similarly sized studies a month earlier. Within two weeks, AstraZeneca paused all its studies globally after a U.K. volunteer had an unexplained illness. U.K. regulators allowed studies to resume quickly, but the U.S. trial remained grounded for more than six weeks before U.S. regulators lifted the hold in October.

Write to Joseph Walker at joseph.walker@wsj.com and Jenny Strasburg at jenny.strasburg@wsj.com

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