CEPI warns of major hurdles to the development of the new Covid-19 vaccine

NSHis world still needs more and better Covid-19 vaccines. However, there are major hurdles that impede the development of new vaccines and the important research needed to determine the best way to use these important tools. Journal Nature.

Unless the country that purchased the vaccine dose and the companies that are already using the vaccine agree to find a way to solve the problem, manufacturers who follow the first wave of producers will find that their vaccine works. You may not be able to prove it. Its slow efforts to vaccinate the planet not only hinder the development of next-generation vaccines, but also whether boosting with another vaccine will provide better protection, or whether to give less vaccine, etc. , Hinders efforts to answer important public health questions. Fraction — Dose has the potential to protect more people more quickly.

This letter was signed by Melanisaville, Director of Vaccine Research and Development at CEPI.

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In an interview with STAT, CEPI’s US director Nicole Lurie said the organization had been trying to break log jams for months, but it didn’t help. “We are spinning around.”

This issue is partly due to the fact that testing new vaccines against placebo at this point in the pandemic is not considered ethical. Instead, you should test against one of the existing shots. However, it is nearly impossible to obtain a licensed or licensed vaccine for research purposes. All available doses have been surged by countries eager to vaccinate as many citizens as possible.

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These dose contracts include strict rules regarding how vaccines are deployed. Dosages often have to be used in the country of purchase. When the Biden administration wanted to share AstraZeneca doses with Canada and Mexico in March It lent the dose To avoid restrictions. The contract also often stipulates that the dose purchased should be used for developmental control, not for research purposes, Lurie said.

There is little benefit to making vaccine doses available to companies for research purposes. Manufacturers can sell all doses that can be manufactured, as global demand far exceeds current supply.

And there are potential drawbacks. If clinical trials testing a new vaccine show that it is superior to the vaccine compared, it will not help future sales of comparator vaccines. Similarly, if one study shows that it is better to use another vaccine as a booster shot (called a heterologous boost). Undercut plan Manufacturers such as Pfizer and Modana sell third shots of the vaccine.

There are many questions that need to be answered about the best way to use the Covid vaccine. And the only way to answer them is to carry out research — needing vaccines like Pfizer-BioNTech’s Comirnaty and Moderna’s Spikevax, and Johnson & Johnson and AstraZeneca vaccines and shots from manufacturers outside North America and Europe. Research to be.

“Whether it is an interval [between doses], Whether it’s a heterogeneous prime boost [studies]Whether it’s a boosting strategy or a divided dose … whether you need an approved vaccine, “Lurie said. “And you can’t get the vaccine. That’s the basic problem.”

The problem must not be insurmountable. Korean vaccine maker SK Bioscience recently announced that it will begin Phase 3 trials of a vaccine being developed in collaboration with vaccine giant GSK, which supplies booster immune compounds known as adjuvants. The clinical trial will compare the SK vaccine with the AstraZeneca vaccine. SK bioscience To generate AstraZeneca vaccine.

In terms of health policy research, so-called mixed-and-match trials are being conducted in both the United States and the United Kingdom. The goal is to see if it is more effective to use two different vaccines than to use the same vaccine for both priming and boosting doses.

NS U.S. trialConducted by the National Institute of Infectious Diseases, 3 vaccines Permitted to use in this country: Pfizer, Modana, J & J vaccines. NS British trialI am studying the combination of Pfizer, Modana, and AstraZeneca vaccines conducted by the University of Oxford. All of these are licensed for use in the United Kingdom. We are also researching Novavax vaccines that require an emergency use authorization. From the UK regulator.

However, in both cases, the study is only conducted with vaccines that are approved for use in the country in which the study is being conducted. In other words, it’s a question that has global impact. For example, if boosted with a Pfizer, AstraZeneca, or Novavacs vaccine, could some of the Chinese vaccines be more effective? — These studies cannot answer.Neither Chinese vaccine is licensed in the US or UK

Lully said CEPI is ready to fund some of these important studies, but “advancing any of these things requires us to be vaccinated. “.

The dose of vaccine required is not large. Phase 3 trials of the new vaccine may require 20,000 doses of comparator vaccine. Phase II trials that measure immunogenicity (the level of antibody produced by the dose of the vaccine) require significantly less. In a UK trial called Com-COV2, more than 1,000 volunteers have been vaccinated for a third time, which is different from the original vaccination plan. The US trial is even smaller, with about 150 participants.

Lully said the problem could be resolved if the country buying the vaccine changed the contract with the supplier. Many were initially motivated, but when they realized the amount of work they were involved in, she said progress was stalled.

“We have a global problem to solve,” Lurie said. “Unless we can move forward, we stick to the vaccines we have.”