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Home / World / The UK authorizes the production of Covid-19 vaccines from Oxford and AstraZeneca

The UK authorizes the production of Covid-19 vaccines from Oxford and AstraZeneca



LONDON-On Wednesday, the United Kingdom became the first country to urgently authorize the coronavirus vaccine developed by AstraZeneca and Oxford University, which opened the way for cheap and easy-to-storable injections, which many parts of the world will rely on to help End the pandemic.

In order to expedite the bold decision to vaccinate, the British government advisory agency instructed clinicians to give people as much of the first dose of coronavirus vaccine as possible, instead of retaining the planned second dose.

The government stated that instead of giving two injections within a month, clinicians will wait up to 1

2 weeks before giving people a second injection. This decision applies to the Oxford-AstraZeneca vaccine and Pfizer-BioNTech authorized by the United Kingdom. Injection earlier this month.

In the United Kingdom and the United States, vaccination work is progressing slowly. Therefore, British officials have been calling for the second dose to be postponed to allow more people to receive partial protection from a single dose. Health Minister Matt Hancock said that people will start receiving the AstraZeneca vaccine early next week.

For the United Kingdom, a large number of new, more contagious new virus variants have overwhelmed a large number of hospitals, and the decision of its drug regulatory agency provides some hope for probation. The health service department is preparing to vaccinate 1 million people every week in temporary spaces in football fields and racetracks as soon as possible.

The Oxford-AstraZeneca shooting program has become the world’s main form of vaccination. Three to four dollars per dose is only a small part of the cost of some other vaccines. And it can be transported and stored at normal refrigeration temperature for six months, instead of using the ultra-cold freezer required by Pfizer-BioNTech and Moderna’s competitor vaccines, making it easier to manage to the poor and hard to reach people world.

When the full-strength vaccine was given in two divided doses, AstraZeneca’s vaccine showed 62% efficacy in clinical trials-far below the 95% efficacy achieved by Pfizer and Moderna injections. For reasons unknown to scientists, AstraZeneca’s vaccine showed 90% efficacy in a small group of volunteers who received a small half-strength initial dose.

When the UK Ministry of Health announced its approval on Wednesday, it did not immediately outline the approved dosing regimen, nor did it outline whether clinicians have leeway to choose between the two.

In addition to the dosage issue, the British health service must figure out how to persuade people to take vaccines that seem to be less effective than other available vaccines, but this may accelerate the end of the pandemic, which causes hundreds of people in the UK every day death.And thousands around the world

The authorization is based on data from late-stage clinical trials in the UK and Brazil. It is expected that the Indian drug regulatory agency will soon decide whether to approve the vaccine, which is produced there by the local vaccine manufacturer Serum Institute.

In the United States, there is a further decision. The Food and Drug Administration (FDA) is waiting for data from another clinical trial. As the regulator investigated whether the disease of the British participants was related to the vaccine, the study was suspended in September and postponed for almost seven weeks, much longer than in other countries. U.S. regulators finally allowed the trial.

In recent days, the Oxford University scientists who developed this vaccine have fallen into a debate on both sides of the Atlantic about whether to postpone the planned second dose and other vaccine doses in order to provide more people with partial protection of a single dose. . The head of Oxford Vaccines, Andrew Pollard, said in a radio interview on Monday that by delaying the second dose of vaccine, “it makes sense to start with as many people as possible.”

AstraZeneca has set an ambitious production target larger than other vaccine manufacturers and stated that it is expected to reach 3 billion doses annually. Taking two doses per person is enough to vaccinate one-fifth of people worldwide. The company has promised to provide the service globally at a cost price at least until July 2021, and to permanently provide the service in poorer countries/regions.

But the company is also plagued by communication errors that undermine its relationship with US regulators and question whether the vaccine can withstand rigorous public and scientific scrutiny. These mistakes frustrated the vaccine schedule in the United States. The major US FDA officials were shocked that they learned of the suspension of clinical trials in September not from AstraZeneca but from the news media.

These setbacks have not diminished Britain’s enthusiasm for the country’s leading home-grown vaccine, and analysts say that if it is launched quickly, Prime Minister Boris Johnson’s nursing term may reverse this trend.

The UK has ordered 100 million doses of vaccines, of which 30 million doses are expected to be obtained in March, and the UK has made AstraZeneca a key to its vaccination strategy. Since Pfizer’s vaccine was authorized on December 2, Britain has used it to vaccinate hundreds of thousands of people. However, the country has been managing outside hospitals and doctors’ offices, leaving some of the highest-priority recipients (such as nursing home residents) still vulnerable.

In clinical trials in the UK, a small number of volunteers received the first dose of half-strength due to measurement problems. Oxford University hired an external manufacturer to produce the vaccine. However, when the researchers received the vaccine sample, they found that its strength was twice the strength found by the manufacturer using other measurement techniques. The researchers did not know which measurement method to trust, so they decided to cut the dose in half to ensure that the volunteers would not get twice the dose originally intended. Later, researchers at Oxford University confirmed that their reading volume was too high, so they returned to the originally planned dose for the second injection.

Among the 2741 people who received the first half-strength dose or meningococcal vaccine as a control, the vaccine’s effectiveness was 90%. None of these participants were over 55 years old, so it is difficult to know whether these results will be applied in the elderly.

Scientists at AstraZeneca and Oxford University said they did not know why the half-strength initial dose was so effective. But they expressed confidence in their results, especially finding that no one received the vaccine in clinical trials that caused severe Covid-19 or hospitalization.

Pascal Soriot, CEO of AstraZeneca, said in an interview with The London Times on Saturday: “We think we have figured out the formula for success and how to achieve other results after two doses. Human efficacy.” The company has not yet released any evidence that the efficiency reaches that of Pfizer or Moderna. Soriot told The Times: “I can’t tell you anymore because we will publish it at some point.”

Scientists at the University of Oxford published the mid-term findings of a clinical trial of the vaccine in The Lancet earlier this month. The final results of those clinical trials are not expected to differ significantly from the interim data.

As of last week, AstraZeneca’s trials in the United States have recruited more than 27,000 participants, only slightly below its target of 30,000. The U.S. federal government’s efforts to quickly track the coronavirus vaccine, Moncef Slaoui, the head of the “distorted speed” operation, said at a press conference in the United States that the trial may produce results and if If the result is affirmative, it will lead to emergency authorization in the United States in February or March. last week.

AstraZeneca executives have publicly proposed some ideas to collect more data on more promising dosing regimens. They said in November that they were considering adding an institution to the ongoing US trial or starting a new global trial. But so far, these suggestions have not been implemented.


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