Firms won’t share COVID-19 vaccines, stalling future vaccine research | Chemistry

The U.S. government has tens of millions of unused messenger RNA (mRNA) COVID-19 vaccine doses and routinely discards doses after their expiration dates. While this is a disastrous result that reflects the recent spread of vaccines, it is also a serious obstacle for scientists testing and developing vaccines that will protect against future SARS-CoV-2 variants and the next pandemic. Developers need existing vaccines as a benchmark against which to compare new candidates. However, government contracts with vaccine manufacturers and the companies’ own policies prohibit the use of vaccines for research purposes.

“At this stage, when millions of vaccines are about to be scrapped, this seems insane,” said Nicole Lurie, U.S. director of the Coalition for Epidemic Control Innovations (CEPI). The situation is so dire that one start-up has created mimics of the mRNA vaccines used so researchers can improve their formulations.

Most of the researchers working on next-generation vaccines, to protect people from all sarvecoviruses (a group that includes SARS-CoV-2, SARS-CoV-1, and related viruses found in wildlife such as bats), We want to develop products that stimulate broader immunity. Animals that can affect humans. As part of the development process, researchers hope to compare the candidate in animal models to the proven mRNA vaccines from Moderna and Pfizer. They want to know how the immune response to the candidate overlaps with the response generated by current vaccinations. They also want to give animals existing vaccines and “challenge” them with different SARS-CoV-2 variants.

CEPI, which aims to accelerate vaccine development, invested $230 million for 13 such vaccine candidates. National Institute of Allergy and Infectious Diseases (NIAID) committed It has donated about $60 million to seven other academic teams working on so-called pancoronavirus vaccine development with similar goals. Four groups supported by CEPI or NIAID said: chemistry Progress has been slowed because comparative vaccines have been difficult to obtain for many years. “It was very difficult and difficult to get these direct comparables,” said CEPI Director In-Kyu Yuon.

Neither NIAID nor the Agency for Biomedical Advanced Research and Development, which purchases and distributes Pfizer and Moderna vaccines, responded. chemistry‘s question.

The first efficacy trial of the Pfizer and Moderna mRNA vaccines compared these vaccines to a placebo vaccine. However, once these products received Emergency Use Authorization in December 2020, they became the baseline for comparison in future efficacy trials.of first push Comparators were provided by developers who developed COVID-19 vaccine candidates based on non-mRNA technologies, such as viral vectors and nasal delivery.

Researchers aiming for broader protective vaccines now need comparators to improve the design of their own candidates. The Pfizer and Moderna vaccines now have full approval from the Food and Drug Administration (FDA) and are generally available for research to purchase and study. However, due to a pandemic emergency, the U.S. government owns all products and cannot provide them for research purposes due to corporate contracts. The contract stipulates that the vaccine can only be used to vaccinate humans, a breach that theoretically could raise corporate liability issues.

The original doses of the Pfizer and Modern vaccines, which contain surface proteins of early strains of SARS-CoV-2, are of limited value for comparison. Both companies are now manufacturing a “bivalent” product that mixes the surface proteins of early strains of SARS-CoV-2. A subspecies of Omicron. But they are also bound by government purchase agreements.

Companies may make vaccines available. But Pfizer and Moderna never intended to discuss the issue. chemistryHowever, Pfizer has confirmed that its vaccine is not sold in any private market. “Except for certain government-funded research institutions, we currently do not provide direct offerings to other research institutions outside of our own targeted clinical development programs,” the company said.

Philip Krause, who spent 11 years as deputy director of the FDA division that oversees vaccines, said he understands why companies marketing vaccines might be skeptical about sharing vaccines with potential competitors. “But obviously it’s going to have a huge public health impact,” says Krause, who is now a vaccine consultant and retired from the FDA in 2021. “If they’re throwing a dose away, or that dose can’t actually be given to anyone, it’s even worse.”

PrEP4All, a nonprofit organization that advocates for improving the public health response to the COVID-19 pandemic, announced in April: sharp and critical report It is based on a six-month study that involved many stakeholders and reviewed government contracts. “This is a very solvable problem and must be addressed now. [a] The report concludes with the title, “A New Crisis.” science held hostage.

Some have taken workarounds. Duane Wesman, an immunologist at Brigham and Women’s Hospital, who received one of the multi-year grants from NIAID to develop a pan-sarvecovirus vaccine, said there were “many requests” for comparators to use in mouse studies. after months of rejection on many fronts.” The group resorted to using an expired Pfizer mRNA vaccine. “It’s not ideal, but the vaccine works very well in mice,” says Wesemann.

In another compromise, Helix Biotech has cleared pancoronavirus researchers’ frustrations by creating generic versions of Pfizer and Moderna’s vaccines using publicly available formulations. Helix’s clients include her NIAID, which provides comparators to the researchers it funds. Graham Taylor, who founded Helix Biotech last year, said his lab had shown that counterfeits provoke immune responses similar to the real McCoy.

Helix products cannot serve as comparators to help pansarvecovirus vaccines gain FDA approval. You need the real thing for that. Kraus said that if human trials show that a pan-sarvecovirus vaccine provokes an immune response similar to that elicited by the best available approved product, a concept known as immunobridging, regulatory approval will be granted. Officials said they might be satisfied. Alternatively, it may require developers to conduct direct clinical trials using reduction in mild COVID-19 disease as an endpoint. Either way, Moderna or Pfizer would have to allow their bivalent vaccines to be used.

Animal studies may test the protective range of pan-sarvecovirus vaccines, but they will need exposure to new variants, and even novel coronaviruses, to deliver on their promise. That can only happen in effective real-world research after a new virus begins to spread.

The unused COVID-19 vaccine boxes currently lying in the freezer present new hurdles for a pan-sarvecovirus vaccine, Krause said.