Monday, January 18, 2021

UK approves AstraZeneca COVID-19 vaccine

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UK government approved AstraZeneca Covid-19 vaccine for emergency use, becoming the first government to do so.

The UK medicines regulator’s decision will pave the way for tens of millions of Britons to be vaccinated in the coming months. Britain had pre-ordered 100 million doses of the vaccine, more than any other vaccine candidate.

It is the second vaccine to receive emergency use authorization in the UK, after approval of Pfizer and BioNTech vaccine early December.

“Today is an important day for millions of people in the UK who will have access to this new vaccine,” Pascal Soriot, chief executive of AstraZeneca, said in a statement. “It has been shown to be effective, well tolerated, simple to administer and is provided by AstraZeneca for no benefit.”

UK approval may also encourage other governments around the world to authorize the vaccine as well. Many public health experts see the AstraZeneca vaccine as crucial in the global fight against coronavirus because it is cheaper and can be stored at much higher temperatures than many of the other vaccines in development.

AstraZenca has signed agreements to manufacture and supply more than 2 billion doses of its vaccine. In addition to the doses committed in the UK, this includes an agreement to deliver 300 million doses to the United States, 400 million to the European Union and 1.3 billion doses specifically to low-income countries.

Cheaper than competing vaccines

The company has promised not to make any profit on the vaccine during the pandemic period. For this reason, and because of the simpler manufacturing methods of this vaccine compared to some of the other candidates, AstraZeneca priced the vaccine at just $ 3 to $ 4 per dose, relative to price. at least five times higher for many competing vaccines.

The vaccine, developed by AstraZeneca, based in Camrbidge, England with scientists at the University of Oxford, was deemed safe in large clinical trials in the UK, Brazil and South Africa. But the data also showed that the vaccine was potentially less effective than those from biotech company Moderna and the Pfizer and BioNTech.

These two vaccines were approximately 95% effective in clinical trials. In contrast, AstraZeneca’s vaccine was only 62.1% effective when given in two standard doses four weeks apart, according to clinical trial results published in the medical journal. The Lancet. But, for a smaller cohort, it was found to be 90% effective when half a dose has been given initially, followed by a full dose. This smaller cohort, however, did not include anyone over 55.

Confusion over these results—And how the smaller cohort came to receive the half-dose regimen – undermined AstraZeneca’s share price, which had reached all-time highs largely on the company’s status as as a leader in the vaccine raffles.

The results clouded the outlook for AstraZeneca’s vaccine, with some speculating that the United States Food and Drug Administration will not allow it for use in the United States, at least until more trial data. clinics are available. AstraZeneca is currently conducting a 30,000-person trial of the vaccine in the United States

It is not known which dosage regimen will be used in the UK as part of the emergency use authorization, but government and company statements have suggested it would be a regimen in which people would receive two standard doses. The government said its plan was to give as many people at risk as possible a first dose of the vaccine, offering some protection, with a second dose given within 12 weeks, rather than the four-week period used in it. ‘clinical test.

The hope, the government said, is that this will allow more people to be vaccinated and to obtain at least some protection against existing stocks of vaccines.

AstraZeneca’s vaccine works differently from those approved so far by Moderna and Pfizer / BioNTech. These vaccines use messenger RNA (mRNA) to instruct cells to produce proteins associated with the coronavirus, eliciting an immune response from the body. The AstraZeneca vaccine uses a method developed by researchers at the Jenner Institute in Oxford that uses a chimpanzee virus that has been genetically modified to produce the coronavirus spike protein.

The vaccine can be stored at normal refrigerator temperatures, between 2 degrees Celsius and 8 degrees Celsius (32.5 to 46.5 Fahrenheit) as opposed to -70 degrees Celsius (-94 degrees Fahrenheit) for mRNA vaccines. These extremely low temperatures created a logistical problem for the distribution of mRNA vaccines. For example, in the UK, where GPs are currently administering COVID-19 vaccination efforts, many have not been able to participate in the inoculation campaign so far because they lack equipment for store vaccine vials at these ultra-low temperatures.

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