COVID-19: Novavax Seeks EUA for Booster, TB Vaccine may Hold Promise and More

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Entering the third year of the COVID-19 pandemic, it’s clear we’ll have to learn to live with the disease. That said, the biopharma industry is keeping its figurative foot on the pedal with R&D focused on helping us to manage it. 

Novavax Seeks EUA for COVID-19 Booster

Novavax submitted an application to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for its COVID-19 vaccine to be used as a booster shot. The vaccine was granted an EUA in adults 18 and older in July. The submission is based on data from the Phase III PREVENT-19 trial in the United States and Mexico and from the U.K.-sponsored COV-BOOST Phase II study.

“It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” Stanley C. Erck, president and CEO of Novavax said in a statement. 

A 100-Year-Old TB Vaccine Might Protect Against COVID-19

Investigators at Harvard Medical School and Massachusetts General Hospital published research showing the potential of multiple doses of the bacillus Calmette-Guerin (BCG) tuberculosis vaccine against COVID-19 and potentially other infectious diseases. They conducted a study in type 1 diabetes patients before COVID-19-specific vaccines were available. 12.5% of people in the placebo cohort had confirmed COVID-19, compared with only 1% of the BCG-treated cohort — meaning vaccine effectiveness of about 92%.

The BCG vaccine also offered protection against other infectious diseases and decreased symptoms. It was first introduced in 1921 as an avirulent TB strain of Mycobacterium bovis and is given to about 100 million children around the world every year. It also costs less than a dollar per dose in most parts of the world.

Back to School - Without Masks

As kids head back to school, most districts have abandoned masking requirements. And in many cases, other public health measures appear to have been left by the wayside. One example is Massachusetts, where the emphasis is on personal responsibility. Even asymptomatic students and staff are not required to quarantine, regardless of vaccination status, though the state does recommend masking for ten days after exposure.

“With COVID-19 vaccines now readily available, treatments accessible to those at higher risk, for severe disease, and widespread availability of self-tests, DESE and DPH have continued to evolve our support for schools in collaboration with the medical community and in line with the most recent CDC guidance issued August 11, 2022,” DESE commissioner Jeffrey Riley and DPH commissioner Margret Cooke said. 

Public Health Officials Struggle with Fall Planning

Public health officials in charge of vaccination programs recognize that this fall is going to be complicated. In addition to the usual fall influenza vaccine drives, the U.S. plans to roll out updated COVID-19 boosters. As noted, flu shots typically wane, so people don’t want to get it too early. Although it’s tough for epidemiologists to predict exactly when flu season will peak, they don’t want to recommend flu shots in September, for example, if the peak of flu season will be in February.

They have a similar problem with COVID-19 boosters, as people will be considering their third, fourth and even fifth shots when the Omicron-specific bivalent vaccines become available. Yet with two winters of COVID-19, no one knows when another surge will occur, what variant it will be and even if it will happen, since Omicron subvariants have spread effectively through the summer.

Claire Hannan, executive director of the Association of Immunization Managers, told STAT News, “I used to think that flu was really challenging. There was never a year that was the same as the previous year. And I think the challenges around supply and trying to plan and optimal planning, they’re very difficult...And throwing COVID boosters into the mix, it just makes it more complicated.”

Pfizer’s Bourla Tests Positive for COVID-19

Pfizer’s CEO, Albert Bourla, tested positive for COVID-19 on Monday. He indicated he is experiencing “very mild symptoms.” In a statement, Bourla said, “I would like to inform the public that I have tested positive for COVID-19. I am thankful to have received four doses of the Pfizer-BioNTech vaccine, and I am feeling well while experiencing very mild symptoms. (I) have started a course of Paxlovid.”

MediciNova Plans to Test Ibudilast in Long COVID Study

MediciNova plans to participate in RECLAIM (Recovering from COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial). This is a grant-funded, multi-center trial. The company intends to evaluate MN-166 (ibudilast) and other drugs for Long COVID. It is collaborating with the University Health Network, an academic health sciences center in Toronto. The study is funded by the Canadian government. 

Ibudilast is a small molecule that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is being otherwise developed for amyotrophic lateral sclerosis (ALS), multiple sclerosis, degenerative cervical myelopathy, glioblastoma, chemotherapy-induced peripheral neuropathy and substance use disorder. It has also been evaluated in COVID-19 patients at risk for developing acute respiratory distress syndrome.

Revive Therapeutics Amends Trial Protocol for COVID-19

Revive Therapeutics reported plans to amend its Phase III trial of Bucillamine in mild to moderate COVID-19. The drug is an oral therapy with anti-inflammatory and antiviral properties. After studying the supporting pre-dose selection data with the unblinded statistician team, it is proposing new primary efficacy endpoints, which it will submit to the FDA for further discussion. The new proposed endpoints may include the time to resolution from COVID-19 via PCR test and the rate of sustained clinical resolution of certain COVID-19 symptoms.

Bharat Biotech Submits Intranasal COVID-19 Vaccine Candidate to Regulators

India’s Bharat Biotech submitted data from Phase III trials of BBV154, its intranasal COVID-19 vaccine, to India’s drug regulatory body. It is requesting approval for a primary two-dose regiment and a booster dose that could be used with other vaccines. 

“Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract,” the company stated. “These may provide the potential to reduce infection and transmission. Further studies are being planned.”

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