Inhalation Vaccine Promises to be a Powerful Tool in the Prevention and Control of Omicron

Omicron, as the most transmissible variant of SARS-CoV-2, is rapidly spreading over the world and has displaced Delta as the dominant strain in a number of regions. Some experts have indicated that mucosal immunization of the respiratory system with an inhaled form of the vaccine may be more efficient in dealing with the Omicron strain in light of recent results that demonstrate Omicron infections are more concentrated in the upper respiratory tract. Several inhalation vaccines for COVID-19 are also on the horizon in the global fight against Omicron, and are expected to become another major weapon.

Omicron possesses more mutant sites and is more contagious than prior strains, with the majority of them residing in the upper respiratory system rather than the lungs.

While the existing intramuscular vaccines on the market today generally have only humoral and cellular immunity, the vaccine given in the arm produces antibodies in the blood, but few antibodies reach our nasopharyngeal mucosa, which, together with the gradual decline in the level of neutralizing antibodies in the body after vaccination, means a weakening of the immune effect, together with the new characteristics (high immune escape, infestation of the upper respiratory tract) arising from the mutation of strains such as Omicron. Therefore, a vaccine booster has become a widely promoted policy after mass vaccination.

Vaccines with mucosal immunological effects are more effective in preventing respiratory viral infections in general, but the inhaled COVID-19 vaccine accesses the respiratory system and lungs through inhalation, triggering triple protection against mucosal, humoral, and cellular immunity. As a result, while dealing with the Omicron strain, the inhalation vaccine becomes a potentially more effective approach.

Multiple studies back this up: Yale immunologist Akiko Iwasaki and her colleagues published a preprinted paper in which they found that a transnasal vaccine booster shot increased the production of strong antibodies and immune memory cells in the respiratory mucosa and improved protection against the initial vaccination in rats. Furthermore, studies published in the internationally renowned medical journal The Lancet found that adverse responses were less common following heterologous boosting with inhaled COVID-19 vaccine than after homologous boosting with the live attenuated vaccine.

The immunogenicity results showed that the peak was attained 28 days after the inhalation booster, and the neutralizing antibody level was significantly higher than that of the live attenuated vaccine homologous booster group, which was 10.7 times higher. There were no serious side effects in the inhalation group 28 days after booster vaccination, and there were no clinically significant lung function abnormalities in the different dose inhalation groups. It is safer, has fewer negative side effects, and is more suited to the elderly and children.

Inhalation vaccine development is also in full swing around the world, with Bharat India and Washington University in St. Louis collaborating on the BBV 154 vaccine, which entered clinical phase III earlier this year and is expected to be one of the world’s fastest inhalation COVID-19 vaccines to hit the market.

Yu-u-uk.

Well, it looks like it will more than exceed historical FDA requirements for approval under emergency use authorization.

Unfortunately, that is the case. “A team from Yale University has developed a new airborne method for delivering mRNA right to your lungs.”

By releasing the vaccine in the air, there’s no need to inject each person individually — which is not only time-consuming but difficult if an individual objects to the shot. This isn’t the case with an airborne vaccine, which can be released into the air without consent or even the public’s knowledge.

Hmm, where have we heard that before?

As recorded in the Federal Register:
"The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.

This rule is effective January 22, 2024."

@cataliesw No need to ask whether you would agree to voluntarily participate in any remaining human trials in order for the vaccine product(s) cited above to get FDA approval.