The Covid vaccine competition has entered a critical stage, and it is unlikely that the first-line competitors will be approved before Christmas.
In an interview with The Guardian, Kate Bingham, head of the British Vaccine Working Group, said that the UK is in “a very good place.”
But in the next few weeks, there are still many obstacles to be resolved.
Sarah Boseley, the health editor of the Guardian, explains the challenges ahead.
In a few weeks, the first results will show whether a vaccine really works. Vaccines are hailed as the world’s greatest hope. The hope is to curb the social and economic destruction caused by the deaths and the Covid pandemic, and the world will hold its breath.
It may be a collaboration between Oxford University and AstraZeneca Pharmaceuticals. It may be Moderna in the United States. It can also be Pfizer and the German company BioNTech.
These three people have either recruited thousands of volunteers, they need to conduct a critical final experiment, or they will recruit soon.
And at some point in November or December, their independent monitoring committee will “unhide”
Exciting. Bingham understood this.
She said: “I just saw that this is a very sensitive topic. Everyone is very eager to get rid of the blockade and return to a normal state. Everyone is annoyed by it.”
“I think my main message is that we are in a very good position. The facilities in the UK are perfect and we have a very attractive portfolio. In terms of having the right vaccine and knowing when it will arrive, we are definitely well planned and organized. “
The UK has purchased six of the hundreds of vaccines under development. Two of its three companies have entered the final round of acquisitions, namely AstraZeneca and Pfizer. Bingham said she thinks there is a chance to get the vaccine before Christmas.
“They must have enough cases to prove the efficacy of the vaccine, and the regulator must approve it. If all of this happens, then we might get the vaccine on Christmas Day,” she said.
“But, you know, I call this a slim chance, and I think it’s a slim chance. I think we have a greater chance of generating this data early next year, but that’s not to say it’s impossible. “
Everything is open…
Phase III test
In these final trials, up to 50,000 people can be recruited, with half receiving experimental vaccines and the other half receiving other vaccines. The trial is blind. No one knows who has what.
The code for the vaccine distribution is kept in a secret file on the computer until enough people participating in the trial are infected with the coronavirus.
Then, independent experts will look for the drugs they are using.
It is hoped that most, if not all, people with Covid-19 will not get the coronavirus vaccine.
Although volunteers are told how to reduce their own risks and may live in areas with lower infection rates, this interim analysis may come soon.
This is because the three companies said that when the number of infected samples is still small, they will start looking at the data.
Moderna said it will first find 53 cases of coronavirus infection among trial participants, followed by 106 cases. AstraZeneca said it will observe in 75 cases.
Pfizer is only waiting for 32 infections and will recheck 62, 92 and 120 infections. People generally expect them to announce first. They originally planned to watch it in September.
CEO Albert Bourla is ambitious and hopes to be vaccinated before October-Donald Trump and others are excited, and he thinks this can be done before the US presidential election.
But the time scale has decreased. Pfizer said on Tuesday that it has not yet conducted an investigation-which may mean that there have not been enough infections.
There are now further delays because after the Oxford University/AstraZeneca trial was suspended, the US regulatory agency, the Food and Drug Administration (FDA), increased the safety bet because the two fell ill separately. The FDA has stated that it will not consider urgent approval of any vaccine unless at least half of the participants have safety data within two months of the last injection. This means that Pfizer cannot submit before the end of November.
Miracle in one breath?Unfortunately no
Expectations about what the first vaccine will do may be too high. It will not end the pandemic. However, it is likely that something has transcended the regulations of the regulatory agency.
To be approved, it must be at least 50% effective. And it must be safe. Everyone agrees that cutting corners can lead to disaster.
CEPI’s Epidemic Prevention Alliance, Dr. Nick Nick, said that even if we are using vaccines, we must still monitor its safety. The alliance is supporting the development of global vaccines. There are currently 9 vaccines. He cited the famous microbiologist Maurice Hilleman (Maurice Hilleman), who participated in the development of 40 vaccines. Hillerman said: “Many years ago, when he took the 3 billionth dose, he was relieved. Therefore, after obtaining these initial permits, continuous security monitoring is absolutely vital.” Say.
CEPI has slightly different standards for leaders. Jackson, the head of planning and innovative technology of the CEPI vaccine research and development team, said that in addition to speed, the scale of manufacturing and acquisition is also critical, so all countries can get the vaccines they need to vaccinate those at the highest risk. Vaccination.
“I think that today can be said to be the leaders of AstraZeneca, Pfizer and Novartis (Novavax), but we do realize that there are others who follow. We must not forget that China is also making major efforts. Sinovac is a company. The company’s vaccine is a good example. The company’s vaccine meets certain standards and does not lag behind the leaders.”
Novavax is another of Bingham’s six product portfolios in the UK and is currently undergoing phase III trials in the UK. “From a manufacturing perspective, it is very active not only in the US but also in other parts of the world. India, South Korea , Prague and Japan”.
Therefore, they should be in a leading position in 2021 to provide doses that could be as high as 2 billion. This is a major contribution to public health. “Jackson said. AstraZeneca is working to produce up to 3 billion doses of drugs worldwide. Both companies have reached a deal with the Serum Institute of India, which can be mass-produced for developing countries.
Obviously, the commercial risks involved in starting to produce billions of doses of vaccine are obvious. But in this crisis, there is no room for such caution.
Jackson said that global participation is amazing.
“I am still surprised by the number of myself-184 economies have signed up to buy or are eligible to buy vaccines from Covax. I think that in terms of the economic strength of signing a specific program, this is only equivalent to the Paris climate agreement. “He said.
He said that at the beginning of the year, they carefully studied all possible ways to accelerate vaccine development.
He said: “We expect 12 to 18 months of vaccines to be available, and we do believe that the target will still be effective in the first half of 2021.” At that time they hope to obtain emergency licenses and release a large number of vaccines, which will make it urgent The immunization campaign started on a global scale.