Are needle-free COVID vaccines our way out of the pandemic?
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Nearly two years into the launch of COVID-19 vaccines, the battle against the coronavirus continues in the U.S., albeit at a low intensity as case numbers, despite being an undercount, have dwindled sharply compared to the Omicron-driven wave late year. Amid concerns over the demand for traditional shots and their efficacy, scientists have focused attention on needle-free COVID vaccines.
Expecting a winter surge, the Biden Administration this month decided to let the pandemic emergency extend past January and announced a six-week program to improve booster uptake even as nearly 20% of Americans have yet to take a single COVID-19 shot.
Intramuscular COVID-19 shots such as messenger-RNA-based vaccines from Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) and non-mRNA vaccines from Johnson & Johnson (JNJ) and Novavax (NVAX) do an excellent job at lessening disease severity and preventing hospitalization.
However, questions about their ability to prevent mild illness and disease transmission have sparked interest in new needle-free inoculations.
Mucosal vaccine pipeline: In September, the Chinese regulators approved an inhaled version of a COVID-19 vaccine developed by Tianjin-based CanSino Biologics Inc. (OTCPK:CASBF) as a booster shot. A few days later, Bharat Biotech, the partner of the U.S. biotech Ocugen (NASDAQ:OCGN) for COVID-19 vaccine development, won the regulatory nod in India for its intranasal Covid-19 vaccine as a two-dose primary shot.
Researchers expect that these vaccines, given as sprays or drops through the nose or mouth and targeting the body's first line of defense, such as the mucosa, will prevent COVID infection and transmission, a high bar.
According to London-based health analytics company Airfinity, over 100 mucosal vaccines are currently in development across the globe, out of which 20 have reached clinical-stage studies. At least four of those â in India, Iran, and two in China â have completed or undergoing Phase 3 trials.
However, the West is playing catch-up in the global market for intranasal COVID vaccines. The approvals in China and India expanded the number of authorized mucosal vaccines to four, including one each from Iran and Russia.
San Francisco, California-based biotech Vaxart (NASDAQ:VXRT) has generated positive Phase 1 results for an oral tablet vaccine for COVID-19, which is expected to offer logistical advantages given its convenient room temperature-stable formulation.
New York-based Oramed Pharmaceuticals (NASDAQ:ORMP) is also advancing an oral COVID-19 shot in a Phase 1 study which is on track for an additional data release before the year-end.

In September, Ocugen (OCGN) announced a licensing deal with Washington University in St. Louis, MO, which is behind the Bharat Biotech vaccine to introduce an intranasally delivered COVID-19 shot in the U.S.
Challenges are ahead despite hope:  The path for intranasal COVID-19 vaccine development is not without setbacks. However, currently used mucosal vaccines offer hope.
So far, regulators have greenlighted nine mucosal shots for humans, out of which eight are taken orally, and one flu vaccine called FluMist, developed by AstraZeneca (AZN), is administered intranasally. An appealing flu vaccine option for young children, FluMist, however, was found to be less effective than traditional shots in older adults.
In October, the medical journal, The Lancet reported that an intranasal form of the vector-based COVID-19 shot developed by pharma giant AstraZeneca (AZN) and the University of Oxford failed in a Phase 1 study.
In June 2021, Altimmune (ALT) said it would discontinue the development of a single-dose intranasal COVID-19 shot due to disappointing Phase 1 data and given the highly competitive COVID-19 vaccine space.
However, the waning pandemic's impact will likely squeeze funding and slow down enrollment for mucosal vaccine studies.
Dr. Anthony Fauci, President Biden's chief medical adviser, says that nasals COVID vaccines in the U.S. are still "a couple of years" away. While Operation Warp Speed supported the science for the first generation of COVID vaccines, Congress has approved little funding for additional vaccine research, Fauci added. 
Louise Blair, head of vaccines and variants at Airfinity, agrees. "There's not the same sense of urgency now" compared with at the beginning of the pandemic, she said. "We are in an abundance of vaccines. Countries at the moment seem to be satisfied with protection against hospitalization rather than infection. So funding and resources are very different, and I don't think we'll see the same speed of development," Blair explained.
Meanwhile, the investigators will find enrolling subjects for mucosal vaccine studies challenging as the number of unvaccinated individuals or those who have not been exposed to COVID-19 decline. There are also ethical concerns about using unproven vaccines when the public already has easy access to authorized COVID shots.
However, even as alternative forms of vaccines emerge, Pfizer (PFE) and Moderna (MRNA) are unlikely to cede leadership in the COVID-19 vaccine market, according to estimates from Airfinity.