White House Says Next COVID Vaccine Could Come in Many Forms
WASHINGTON — The White House is working with partners in the public and private sector on developing the next generation of COVID-19 vaccines, but there’s no telling whether it will take the form of a patch, shot, nasal spray or all three.
“With the National Institutes of Health, and the research and development authority, we’re supporting new private sector innovations. Innovations like nasal sprays and patches to administer vaccines in a more comfortable and accessible way, so everyone in America and around the world can readily benefit from them,” said Alondra Nelson, who leads the White House Office of Science and Technology Policy, during a summit held by the White House on July 26.
Anthony Fauci, who serves as chief medical advisor to President Joe Biden, said during the event that back in January, he and his colleagues wrote in the New England Journal of Medicine that there was an urgent need for a universal coronavirus vaccine.
This is because sublineages of the original COVID-19 strain have shown that mutations of the virus are capable of eluding protection from infection and prior vaccination, and that vaccine-induced immunity and infection-induced immunity is waning.
This is the case for BA.4 and BA.5 variants, which are sublineages of the omicron variant, which made up a total of 52% of new coronavirus cases last week, according to estimates from the U.S. Centers for Disease Control and Prevention.
“A paper that came out literally a couple of days ago from one of our grantees showed it’s very interesting…You may have protection against infection or not, versus protection against severe disease,” said Fauci.
Fauci said the cost of research pales in comparison to the cost of a pandemic, and since the start of the COVID-19 pandemic, the National Institute of Allergy and Infectious Diseases has spent $3.5 billion on coronavirus research, and $1.4 billion on vaccine research.
“Recently, we awarded $42.8 million over three years [to] academic institutions… for the development of broadly protective coronavirus vaccines…and we anticipate additional awards within weeks,” said Fauci.
Fauci said that what are called P01 program project grants are being awarded to grantees to design and implement a pan-coronavirus vaccine, which would protect against all future SARS-CoV-2 variants of concern.
The importance of developing a mucosal vaccine, which would take the form of a nasal spray, was discussed during the event by researchers who have already begun to gear up for clinical trials.
“We’re developing a live, viral mucosal vaccine that showed mucosal immunity, [it] had high efficacy. We’ve enrolled 100 subjects in a phase 1 clinical study. We’re seeing great safety with no vaccine shedding and promised immune responses. Our technology has been studied for another virus in three other phase 1 clinical trials,” said Marty Moore, a representative of Meissa Vaccines, during the event.
While there is promise in developing a nasal spray COVID-19 vaccine, there are also many researchers working to develop a patch vaccine, which could deliver protection from the virus through the skin by way of microneedles that are as long as a piece of paper is thick.
“What we and others have found is if you vaccinate in the skin, you can get a more robust immune response as compared to vaccinating deeper in the body, such as in the muscle,” said Mark Prausnitz, who serves as chief security officer of Micron Biomedical, during the event.
“When the needles enter the skin, they contact the fluids inside the body where they dissolve. You get the added benefit of a dry vaccine that is more thermostable. We can store them for two years at [104 degrees Fahrenheit],” continued Prausnitz.
Even if a new vaccine was developed in the form of a patch, nasal spray, or pan-coronavirus shot, questions remain as to whether Americans will actually still choose to uptake future vaccines.
“No matter how cool these patches [or other vaccines] are, if they aren’t utilized, if people don’t have access to them, they won’t do what they’re designed to do and that is to save lives and protect the economy,” said Michelle Smith, a representative from the Arkansas Department of Health, during the event.
There’s also the issue of getting the vaccines to market in enough time for it to be effective at reducing community spread and severe illness.
”We can have a great drug, a great therapy, but if there’s no way to get it in the market quickly, that doesn’t help the public. The flexibility and a fit-for-purpose way to look at what we need, is one key enabler,” said Angela Hwang, president of the biopharmaceuticals group at Pfizer, during the event.
Hwang said the pandemic made way for companies like Pfizer to undergo an adaptive clinical trial design, where the use of digital technologies and virtual tools enabled researchers to recruit at incredible speeds, but also to recruit in diverse communities.
“We were able to conduct virtual visits and follow-ups, and all of this meant that we were able to bring the trial to the patient rather than have the patient come to a site that may be too far. That’s how we were able to increase the number of patients that we had hoped to have rather quickly,” said Hwang.
Hwang said typically, a clinical trial would go through phase 1, phase 2, phase 3, but during COVID there was no time to do this, which is why the FDA granted the flexibilities necessary and in a fit-for-purpose way to get vaccines to market at lightning speed.
“I think it would be great to be able to see the application of this kind of trial design beyond what we did just for the first COVID vaccine, but to other possible vaccines and to other possible therapies as well,” said Hwang.
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