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‘Maybe’: Race to approve the Covid vaccine at Christmas | Coronavirus

The race for the Covid vaccine is at a pivotal stage, with one of the top candidates being approved by Christmas.

In an interview with the Guardian, Kate Bingham, head of the UK’s vaccine force, said the UK is in “a very good place”.

But there are still hurdles to tackle in the coming weeks.

The Guardian’s health editor, Sarah Boseley, explains the challenges ahead.

The leaders

Within a few weeks, the first results show if one of the vaccines actually working will appear. With a vaccine hailed as the world̵

7;s best hope for preventing the deaths and economic and social destruction caused by the Covid pandemic, the world is holding its breath.

It could be Oxford University, in partnership with the pharmaceutical company AstraZeneca. That could be Moderna in America. Or it could be Pfizer and German company BioNTech.

All three have recruited the last of the tens of thousands of volunteers they need for critical final trials or will soon do so.

And sometimes in November or December, their independent watchdogs will “scatter” their confidential data to find out whether few people who received the experimental vaccine are getting Covid-19. or not.

The excitement can be felt. Bingham understands that.

“I could only see that it was an extremely sensitive subject, that everyone was so desperate to get rid of the lock and get back to normal that everyone snatched the straw,” she said.

“I think my main message is that we are in a very good place. UK is well established, we have a very attractive portfolio. We are perfectly well planned and organized about having the right vaccines in place and knowing when they will come. “

The UK has purchased six of the hundreds of vaccines in development. It has two of the last three falling companies – by AstraZeneca and Pfizer. Bingham said she thinks there’s a chance of getting her vaccinated before Christmas.

“They have to have enough cases to show the vaccine’s effectiveness and regulators have to approve it. If all that happens, then we might have a vaccine this Christmas, ”she said.

“But, you know, I called it a slim opportunity and I think it is a slim opportunity. I think we have a better chance of creating that data early next year, but by no means impossible. “

All turned on …

Phase three trials

In these last trials, it recruited up to 50,000 people, half received the experimental vaccine and half received something else. The trial was blind. Nobody knows who has what.

The vaccine allocation codes are kept on confidential computer files until a sufficient number of test participants are infected with coronavirus.

Then, independent experts will review the medication they were taking.

The hope is that most, if not all, people with Covid-19 will not be vaccinated against the coronavirus.

Although volunteers were instructed to reduce their own risk and may live in areas with low rates of infection, this interim analysis could come quite quickly.

This is because the three companies said they will start looking at the data when the size of the infection sample is still quite small.

Moderna has stated that it will look for the first time when there are 53 coronavirus infections among the test participants, and again 106. AstraZeneca says it will look when there are 75 cases.

Pfizer waited only 32 and will review for 62, 92, and 120 infections. Most of them are expected to announce in advance. Initially they planned to review in September.

CEO Albert Bourla has ambitions for the vaccine in October – Donald Trump is excited among others, who suggested it could be ready ahead of the US presidential election.

But time has slipped. On Tuesday, Pfizer said it was yet to be found – which could mean there aren’t enough infections yet.

And now there is a delay as the US regulator, the Food and Drug Administration, raised the level of safety following a suspension of University of Oxford / AstraZeneca trials, of which two separate sick person. The FDA said it will not consider emergency approval of any vaccine unless there are safety data available in at least half of the participants for two months after the last dose is given. That means Pfizer cannot submit before the end of November.

A one-time wonder? unfortunately

Expectations for what the first vaccine will do is probably too high. It won’t end the pandemic. But there may also be something that crosses the line imposed by the regulators.

To be approved, it needs to be at least 50% effective. And it must be safe. Everyone agrees that cutting corners to accelerate can lead to disaster.

Dr. Nick Jackson, from CEPI, the epidemic prevention alliance, is supporting global vaccine development and has nine vaccines on the list so far, said even if we have the vaccine in use, Safety will still have to be monitored. He cites Maurice Hilleman, the famous microbiologist, who was involved in the development of 40 vaccines. “Years ago, he was only relieved when the third dose was injected,” Hilleman said. Therefore, continuous monitoring to ensure the safety after these initial permits will also be paramount, ”he said.

CEPI has slightly different criteria for the first movers. “ Along with the speed, scale of production and accessibility is also important, so that all countries can have access, ” said Jackson, program leader and advanced technology in the CEPI vaccine R&D group. get what they need to vaccinate those most at risk.

“I think AstraZeneca, Pfizer and Novavax can be said today, but we realize that there are others behind. And we must not forget that China also made some remarkable efforts. Sinovac is a very good example of a vaccine company that meets a number of criteria and is not far behind its predecessors.

Novavax, one of six other companies in Bingham’s UK portfolio and currently in phase three trials in the UK, was “very, very active from a manufacturing standpoint, not just at USA but also in other parts of the world such as India, Korea, in Prague and in Japan ”.

“So they have to be in position by 2021 to potentially deliver up to 2 billion doses. It’s a really important contribution to public health, ”said Jackson. AstraZeneca is working to produce up to 3 billion doses worldwide. For example, both companies have already made an agreement with the Serum Institute of India, able to scale production for developing countries.

The commercial risks associated with starting to produce billions of doses of vaccine could go dumb are obvious. But in this crisis, there is no room for that caution.

Jackson says global participation has been a phenomenon.

“I myself am still amazed at the number – 184 economies that have registered to buy or qualify for vaccines from Covax can, in my opinion, only be compared to the Paris climate agreement on major economic powers. sign a specific initiative, ”he said.

At the beginning of the year, they carefully considered all possible ways to speed vaccine development, he said.

“We anticipate it will take 12 to 18 months for the vaccine to be available, and we think that goal is still in effect in the first half of 2021. That’s when they expect an emergency permit,” he said. Levels and numbers of vaccines to be released will allow much needed vaccination campaigns to begin around the world.

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