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FDA Clears Covid-19 Nasal Spray/Drops Vaccine Trial

Nasal spray

(Pixy.org)

16 Mar. 2021. A company developing vaccines delivered through the nose received FDA clearance to begin a clinical trial of its vaccine protecting against Covid-19 infections. Meissa Vaccines in Redwood City, California says unlike injected vaccines, its nose-drop vaccine can prevention infection from SARS-CoV-2 viruses, as well as symptomatic disease.

Meissa Vaccines is a spin-off company from the lab of virologist Martin Moore while at Emory University medical school in Atlanta. Moore, a co-founder of Meissa Vaccines and now the company’s CEO, studied the respiratory syncytial virus causing cold-like symptoms in most people. But among more vulnerable populations, such as infants and the elderly, respiratory syncytial virus can have more serious consequences. Moore and company chief scientist Rodney Tang founded Meissa Vaccines to commercialize Moore’s work showing an engineered form of respiratory syncytial virus, or RSV, could protect against its infections.

The company’s technology, called AttenuBlock, adapts Tang’s techniques, which combine genetic engineering and synthetic biology to produce a live but weakened virus that induces an immune reaction protecting against infections. That technology weakens the virus by sharply reducing the expression of codons, sequences of three DNA molecules that correspond to specific amino acids in the production of proteins. As a result, the immune system still recognizes the virus as an invader and responds accordingly, but the weakened virus is less likely to result in an infection.

Meissa’s Covid-19 vaccine, code-named MV-014-212, uses AttenuBlock to weaken the SARS-CoV-2 virus, while producing systemic immunity in blood serum, as well as mucosal immunity in nasal passages with immunoglobulin A, or IgA antibodies. Like the company’s RSV vaccine, Meissa formulates MV-014-212 for delivery into the nose, as nose drops or nasal spray.

Clinical trial tests one or two doses at three dosage levels

The company says in preclinical studies with monkeys, MV-014-212 invokes an immune response specifically against the SARS-CoV-2 spike surface protein both in blood serum and IgA antibodies in the nasal passage. Meissa says the tests show the vaccine protects against a SARS-CoV-2 infection challenge in the upper and lower respiratory tract.

The Food and Drug Administration’s clearance enables Meissa Vaccines to test MV-014-212 in an early-stage clinical trial. The trial is enrolling 130 healthy adults, age 18 to 56, testing negative both for SARS-CoV-2 viruses and antibodies. Participants are randomly assigned to receive one or two doses of MV-014-212, at three dosage levels, and either as nose drops or a nasal spray.

The study team is looking primarily for any adverse effects from the vaccine, immediately following administration, then for up to a year after receiving the vaccine. The researchers are also tracking production of neutralizing antibodies in participants, as well as binding but not neutralizing antibodies, and signs of viral shedding for 29 days following administration.

“Compared to injected vaccines,” says Moore in a company statement, “intranasal vaccines have greater potential to stop the transmission of SARS-CoV-2. Furthermore, a single intranasal dose of Meissa’s Covid-19 vaccine candidate, MV-014-212, may be sufficient to generate durable immunity against SARS-CoV-2 and its variants.”

“In addition,” notes Tang, “we have clinical data demonstrating a mucosal immune response from our intranasal RSV vaccine candidate built on the same technology platform. This intranasal RSV vaccine is now in phase 2 and has been well-tolerated in healthy individuals to date, including young children.”

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