The White House wants to develop a vaccine that protects against future coronaviruses. At a vaccine summit yesterday that gathered researchers, companies, and government officials, the White House's response coordinators said that the vaccines they have are terrific, but they can do better. We need vaccines that can protect us from Mother Nature.
No specific funding request to Congress was revealed at the summit so vaccine developers and the public shouldn't expect a second operation warp speed. The scientific, logistical, and regulatory hurdles for next- generation vaccines are higher.
It was possible to get safe and effective immunizations in just 11 months, many times faster than before. There are a few dozen efforts to create vaccines that protect against future SARS-coV-2 mutants or take an even more "pan" approach in order to stop unknown coronaviruses that have yet to jump into humans Only one candidate developed by the U.S. Army has made it into a clinical trial.
Akiko Iwasaki, a panelist at the White House summit who has a vaccine candidate that's administered as a nasal spray, says there are lots of barriers to getting there. The Coalition for Epidemic Preparedness Innovations has invested less than $200 million in 11 efforts run by small companies and academics. There is a lack of materials needed to make vaccines, a shortage of nonhuman primate to test candidates, and uncertainty about how to assess new products in populations that already have immune response to the disease.
Scientists think there is a deeper barrier. The sense of urgentness is gone according to a researcher at the Icahn School of Medicine at Mount Sinai.
Moncef Slaoui is the scientific leader of Operation Warp Speed and a vaccine developer. Even though the ability of today's COVID-19 vaccines to block infections and prevent disease has been eroded, they are still preventing illness and death. Slaoui says that current vaccines are able to deal with the Pandemic. Pancoronaviruses vaccines are not about dealing with the actual epidemic.
The projects underway have a variety of aims and the "pan" in potential next-gen vaccines is often in the eye of the beholder. The most modest, but still ambitious, goal is to avoid racing to create specific boosters that play catch-up with the latest SARS-CoV-2 variant and instead to develop vaccines that can reliably ward off severe disease from any future strains of the Pandemic coronaviruses.
The Fred Hutchinson Cancer Research Center co-leads the clinical trials network for Operation Warp Speed and is most interested in the COVID-19 vaccines that promise to reduce the risk of infection and transmission. Do we really want to have a lot of deaths in the US? "What do you think?" He wants more government support so that the field doesn't get lost in the shuffle. He says there are lots of ideas. There is no commitment.
The next level of vaccines aim to protect against sarbecoviruses, the group that included the cause of the outbreak of severe acute respiratory syndrome 20 years ago. The coronaviruses that cause Middle East respiratory syndrome and the two that cause the common cold are included in the vaccine's target group. The coronaviruses family has four genera.
Melanie Saville is the head of vaccine R&D at CEPI. She says it's a high-risk, high-reward research. People's expectations have to be managed.
There is only one pancoronaviruses vaccine candidate that has reached clinical testing so far. The vaccine tries to improve the way it is presented to the immune system by using the same coronaviruses surface protein that is used in the previous shots. There are several copies of spike bound to ferritin in theWRAIR candidate The surface of the B cells can be used to cross-link to the closely arrayed spikes. The vaccine neutralized a wide range of variant of the disease. The data from the first phase of the study will be published soon.
Other projects have been put on hold because of the limited availability of animals for vaccine testing. There is a lot of competition for monkeys and the best mouse model systems according to Andrew Ward. The most promising vaccine candidates were allocated to the most promising research animals, but now efforts have just become a free-for-all, not a coordinated Manhattan Project.
Iwasaki has had difficulty obtaining monkeys for studies because he believes a nasal spray might be able to broaden protection by stimulating production of mucosal antibodies that have twice as many arms as the Y shaped ones triggered by injection. She says there would have been a government-organized effort to help them.
Two investigator-Initiated grants are funded by NIAID. The other went to Lbachir BenMohamed, an immunologist at the University of California, Irvine, who had hoped to enter clinical trials this year. His team has also had to wait for access to animal models, which they need to pick the most promising vaccine candidate. If his team can overcome another challenge, he will look at the year 2023.
Working with TechImmune, a startup company, BenMohamed's team designed its vaccine candidate by first analyzing sarbecoviruses that have infections in humans and animals. The conserved regions are reflected in the proteins that they make. Similar to the existing Moderna and Pfizer-BioNTech vaccines, their vaccine uses the body to turn the messenger RNA code back into its original form. There is a shortage of the shell that protects the RNA. Jeffrey Ulmer, TechImmune's president, says that they are bumping up against having to wait in line. Demand surpasses supply.
The California Institute of Technology has a promising pan-sarbecoviruses vaccine, but it won't be in the clinic until at least the year 2024. A team has plucked a piece of spike from eight different sarbecoviruses and made it into a mosaic. Her team has faced manufacturing challenges and only received substantial support recently. It is taking longer than expected.
The pancoronaviruses vaccines will have to go through a rougher road than the first shots. The people who took part in the trials of the first COVID-19 vaccine had no immunity to the disease. Most people have been injected with a vaccine or have been bitten by a virus. Barney Graham, who worked on pancoronaviruses at NIAID and helped Moderna develop its COVID, predicts that it will be difficult to establish proof of protection against all known versions of the disease.
Graham, who is now at Morehouse College, notes that the immune response to any new vaccine will be skewed by the memory of the first virus it encountered. It may be necessary to conduct trials in people with no competition in the immune system to assess the new vaccine's ability to provide broader protection. Graham says there are a lot of questions to answer. It won't go as fast as before.
How these vaccines would be used remains a big question. It is a risky idea to develop a panvaccine as insurance. A candidate sitting on the shelf might only have limited efficacy against a particular disease. It wouldn't give developers enough time to make a vaccine for the pathogen.
Graham would rather invest in having knowledge on the shelf to quickly make a vaccine instead of paying to have a panvaccine at the ready that could only hold the fort until you get the real thing a few
If we disrupt the economic model for R&D and take a warp speed approach, development could be up to 10 times faster. He thinks building vaccine manufacturing plants that can quickly make candidates against a new threat is the best bang for buck when it comes to foiling a novel coronaviruses. Someone should be celebrated for coming up with a panvaccine that actually works. We don't know when another outbreak will come and we try it.
All Rights Reserved © 2024
