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Why the approval of the Oxford-AstraZeneca vaccine may be the most important worldwide


The green light from the #British #Medicines and #Healthcare #Products #Regulatory #Agency on #Wednesday could be a big step towards controlling the COVID-19 pandemic worldwide (REUTERS)

The COVID-19 vaccine developed by the #Oxford #University and #AstraZeneca it was not the first to be approved by regulators in the UK; health officials cleared the #Pfizer-BioNTech vaccine nearly four weeks earlier. AND it is not the most effective either: #Stage 3 clinical trials suggest that it prevents COVID-19 symptoms about 70% of the time versus about 95% for the #Pfizer vaccine and a similar one from #Moderna. #But the green light from the #British #Medicines and #Health #Products #Regulatory #Agency on #Wednesday could be a big step towards controlling the COVID-19 pandemic around the world.

#This is great news for the developing world because it is cheaper and easier to handle and store. #Countries from #India to #Brazil and #South #Africa They have made big bets on the formula of the famous #British university and the #Swedish-British pharmaceutical company. The UK was the first country to allow the use of the vaccine, but #India is expected to do the same in a few days. #Trials are ongoing in the #United #States and in many other countries.

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#Questions and big hurdles remain before it becomes available in the US and continental #Europe, where it has yet to receive regulatory approval. #However, when the vaccine is licensed for use and widely distributed around the world, “that is really going to be the beginning of the end of the pandemic,” dice #Ben #Cowling, infectious disease epidemiologist of the #Hong #Kong #University.

#Advantages of the #Oxford-AstraZeneca vaccine

“The approval of this vaccine is a turning point for the pandemic because it has been deliberately developed to have a global impact that includes people living in the most fragile and poorest regions of the world,” said #Helen #Fletcher, professor of immunology ( EFE)

The first thing to know about jab #Oxford-AstraZeneca is that it is cheap. #AstraZeneca has promised that you will not profit from the vaccine during the pandemic. #As a result, costs between USD 3 and 4 per dose worldwide, compared to $ 25-37 per dose for the vaccine developed by #Modern and about $ 20 per serving for the jab of #Pfizer, according to figures reported in #Europe.

“The approval of this vaccine it is a tipping point for the pandemic because it has been deliberately developed to have a global impact that includes people living in the most fragile and poorest regions of the world ”, said #Helen #Fletcher, #Professor of #Immunology at the #London #School of #Hygiene and #Tropical #Medicine.

#Secondly, it is easier to transport and store. #Unlike #Pfizer’s vaccine, which must be stored in specialized freezers at -70 ° C (-94 ° F), #Oxford-AstraZeneca injection requires only standard refrigeration and will remain viable for up to six months. (#Morderna vaccine can be kept at normal freezing temperatures and stored in the refrigerator for up to 30 days after thawing.)

#Further, there will be much more available. #AstraZeneca and #Oxford have worked with manufacturers around the world to produce millions of doses, and the company says it expects to produce 3 billion more in 2021. #With the current two-dose regimen, that is enough to vaccinate almost 20% of the world’s population.

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#He #Serum #Institute of #India, which was contracted to manufacture the COVID-19 vaccine for the developing world, has already manufactured up to 50 million doses and says that it can produce 100 million a month in #March.

#Pfizer, one of the largest pharmaceutical companies in the world, has set itself the goal of managing 1.3 billion doses by 2021. #Moderna, an upstart pharmaceutical company, says expects to produce between 500 million and 1 billion doses. #However, rich countries have already claimed much of the expected supply of #Pfizer and #Moderna vaccine. “#Those vaccines they are already engaged, so that not available for most low- and middle-income countries ”, says the doctor #Chandrakant #Lahariya, #Delhi epidemiologist and author of a book on fighting COVID-19 in #India.

The #Oxford-AstraZeneca vaccine, on the other hand, makes up the bulk of the 2 billion vaccine doses insured by COVAX, a consortium of 190 world governments formed to help ensure that COVID-19 vaccines are distributed fairly around the world, including developing countries.

#How is the #Oxford-AstraZeneca vaccine different?

This technique has already proven successful in the past, including with the Ebola vaccine (EFE)
#This technique has already proven successful in the past, including with the #Ebola vaccine (EFE)

#Oxford-AstraZeneca uses a different technology than the #Pfizer and #Moderna vaccines that are approved for use in the US. #While those two vaccines use the genetic code of coronavirus mRNA to train the body’s defenses, the #Oxford-AstraZeneca vaccine uses a “viral vector”, introducing a harmless virus, in this case a virus that causes the common cold in chimpanzees, modified with the spike protein of the SARS-CoV-2 virus to stimulate an immune response.

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#Other COVID-19 vaccines in the pipeline also use the viral vector method, including one from #Johnson & #Johnson and #Russia’s #Sputnik V. #This technique has already proven successful in the past, including with the #Ebola vaccine. MRNA vaccines, on the other hand, are the first to use that approach to receive authorization.

#Questions remain

#While the UK’s decision to use the vaccine is significant, #Cowling, The HKU epidemiologist says other countries can wait to start administering it until after the #European #Medical #Authority (EMA) or the US #Food and #Drug #Administration (FDA) grant authorization, both of which are considered stricter than the #British regulator.

#An EMA official told the #Belgian newspaper yesterday The newspapaer what #AstraZeneca hasn’t even submitted its vaccine for regulatory consideration yet, and added that approval in #January was not likely.

#Questions also remain about the late-stage trials of the #Oxford-AstraZeneca vaccine. #In #September, #AstraZeneca and #Oxford stopped trials in the UK after a volunteer experienced an unexplained illness, but they didn’t announce the hiatus until it was reported in the media. UK regulators gave the go-ahead to continue testing days later.

#However the #New #York #Times #He reported that US FDA regulators were not notified of the hiatus and taken aback by the news. #It took almost seven weeks before regulators allowed trials to resume in the #North #American country.

There is very little data on how long the protection of the Oxford-AstraZeneca vaccine, or any other COVID-19 vaccine (EFE) will last
There is very little data on how long the protection of the #Oxford-AstraZeneca vaccine, or any other COVID-19 vaccine (EFE) will last

Then in #November data from clinical trials raised questions about dosing. The results showed that the vaccine was 62% effective for subjects who received two full doses, and 90% effective for those who mistakenly received a half dose first and then a full dose. There were also questions about how the data was published and reported.

The company said it maintained the highest standards during clinical trials and reported the dosage issue to authorities when it was discovered. UK regulators signed a plan to continue the trial with the half-dose participants. #However, the group that received half the dose was too small and did not include patients older than 55 years, which means that no firm conclusions could be drawn. #On #Wednesday, #British regulators authorized the use of two full doses, administered four to 12 weeks apart.

#Despite these questions, #Fletcher of the #London #School of #Hygiene and #Tropical #Medicine says that the issue of dosage should not delay FDA and EMA approval; both regulators were only considering authorization for two full doses.

#Further, there is very little data on how long the protection of the #Oxford-AstraZeneca vaccine, or any other COVID-19 vaccine, will last.

#Regardless, he jab from #Oxford-AstraZeneca will almost certainly help turn the tide of the pandemic. “With more than 30 supply agreements and partner networks established globally, #Oxford-AstraZeneca vaccine could curb the pandemic and it should save many lives over the next year ”, concludes the specialist.

I KEEP READING:

ANMAT approved the emergency use of the #Oxford-AstraZeneca vaccine in #Argentina

UK #Approved #Oxford / #AstraZeneca COVID-19 #Vaccine

#When will the #Oxford-AstraZeneca vaccine against coronavirus begin to be applied in #Argentina





[ source link ]
https://www.infobae.com/america/ciencia-america/2020/12/31/por-que-la-aprobacion-de-la-vacuna-oxford-astrazeneca-puede-ser-la-mas-importante-a-nivel-mundial/

#approval ##OxfordAstraZeneca #vaccine #important #worldwide

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