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The race for a Covid vaccine is reaching a crucial stage, with the glimpse of the possibility that one of the top contenders will be approved by Christmas.
In an interview with The Guardian, Kate Bingham, who heads the UK Vaccines Task Force, said the UK was in “a very good place”.
But there are still obstacles to overcome in the coming weeks.
The Guardian Health Editor Sarah Boseley explains the challenges ahead.
The pioneers
In a few weeks, the first results will appear showing whether one of the vaccines really works. With a vaccine hailed as the world’s best hope to stop the deaths and social and economic destruction caused by the Covid pandemic, the world is holding its breath.
It could be the University of Oxford, associated with the pharmaceutical company AstraZeneca. It could be Modern in America. Or it could be Pfizer and the German company BioNTech.
All three have recruited the last of the tens of thousands of volunteers they need for critical final tests or will do so shortly.
And sometime in November or December, your independent monitoring boards will “unmask” your secret data to find out if fewer people who received the experimental vaccines are receiving Covid-19.
The emotion is palpable. Bingham understands.
“I can see that it is such an incredibly sensitive subject, that everyone is so desperate to get out of the confinement and back to normal that everyone is holding on to straws,” he said.
“I think my key message is that we are in a very good place. The UK is well established, we have a very attractive portfolio. We are absolutely well planned and well organized in terms of having the right vaccines and knowing when they will arrive. “
The UK has purchased six of the hundreds of vaccines in development. It has two of the three companies heading to the last stage: AstraZeneca’s and Pfizer’s. Bingham says he believes there is a possibility of a vaccine before Christmas.
“They have to have enough cases to demonstrate the efficacy of the vaccine and the regulator has to approve it. If all that happens, then it is possible that we can have a vaccine this side of Christmas, ”he said.
“But, you know, I’ve called it a small possibility and I think it is a small possibility. I think we have a better chance of generating that data early next year, but that doesn’t mean it’s impossible. “
Everything lights the …
Phase three trials
In these final trials, which recruited up to 50,000 people, half received the experimental vaccine and half received something else. The trial is blinded. Nobody knows who had what.
Codes for vaccine allocation are kept in secret computer files until enough people participating in the trials have been infected with the coronavirus.
Then the independent experts will see what drug they had.
The hope will be that most, if not all, people with Covid-19 have not received the coronavirus vaccine.
Although volunteers are told how to reduce their own risk and can live in areas with low infection rates, this interim analysis could come quite quickly.
This is because all three companies have said that they will start analyzing the data when the infection sample sizes are still quite small.
Moderna has stated that it will take a first look when it has 53 cases of coronavirus infection among trial participants, and again at 106. AstraZeneca has said it will search when there are 75.
Pfizer only waits 32 and will retest 62, 92 and 120 infections. In large part, they were expected to testify first. They originally planned to search in September.
CEO Albert Bourla had ambitions to have a vaccine by October, which excited Donald Trump, among others, who thought it could be ready before the US presidential election.
But the timescale has slipped. On Tuesday, Pfizer said it hasn’t searched yet, which likely means there haven’t been enough infections.
And now there is an additional delay because the US regulator, the Food and Drug Administration, has increased the safety stakes following the pause of the Oxford University / AstraZeneca trial in which two people fell ill separately. The FDA has said it will not consider granting emergency approval to any vaccine unless there is safety data on at least half of the participants within two months of the last dose. That means Pfizer was unable to file before the end of November.
A one-shot wonder? Unfortunately not
Expectations for what the first vaccine will do are probably too high. It will not end the pandemic. But there may well be something that crosses the line imposed by regulatory bodies.
To be approved, it must be at least 50% effective. And it must be safe. Everyone agrees that cutting corners for speed could lead to disaster.
Dr. Nick Jackson of CEPI, the coalition on epidemic preparedness, which supports vaccine development globally and has nine vaccines in its portfolio so far, says that even when we have vaccines in use, safety will still have to. be monitored. Quote Maurice Hilleman, the famous microbiologist who was involved in the development of 40 vaccines. “Hilleman said many years ago that he only breathes a sigh of relief when he has been given the third billionth dose. Therefore, continuous security monitoring after these initial licenses will also be absolutely paramount, ”he said.
CEPI has slightly different criteria for pioneers. Along with speed, manufacturing scale and access are also vital, so that all countries can get what they need to vaccinate those most at risk, said Jackson, who is head of programs and innovative technology on the team. of CEPI’s vaccine R&D.
“I think today, possibly AstraZeneca, Pfizer and Novavax are the pioneers, but we recognize that there are others very close. And we must not forget that China also has some important efforts. Sinovac is a very good example of a company with a vaccine that meets some criteria and is not far behind the pioneers. “
Novavax, which is another of six in Bingham’s UK portfolio and is now in phase three testing in the UK, has been ‘very, very active from a manufacturing perspective, not just in the United States. United, but also in other parts of the world such as India, South Korea, Prague and Japan ”.
“So they should be in a position to potentially provide up to 2 billion doses in 2021. That’s a really significant contribution to public health,” Jackson said. AstraZeneca is working to produce up to 3 billion doses worldwide. Both companies have reached an agreement, for example, with the Serum Institute of India, which can manufacture at scale for developing countries.
The commercial risks of starting to manufacture billions of doses of a vaccine that can prove to be unsuccessful are obvious. But in this crisis, there is no room for that kind of caution.
Jackson says the global turnout has been phenomenal.
“I’m still amazed at the number: 184 economies signed up to buy or are eligible for Covax vaccines, which is only comparable, I think, to the Paris climate accord in terms of economic powerhouses signing up for a particular initiative.” he said.
Earlier in the year, they carefully looked at all the possible ways vaccine development could be accelerated, he said.
“We predicted that it would be 12 to 18 months for vaccines to become available, and we believe that goal will remain valid in the first half of 2021,” he said. That’s when they expect emergency licenses to be in place and vaccine volumes to be released allowing much-needed immunization campaigns to begin around the world.
