Inhaled COVID-19 vaccines making inroads in China, India and Russia

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

The idea of inhalable COVID-19 vaccines may not be new, but, until recently, no country had approved a COVID-19 vaccine with an alternative delivery route.

That changed on March 31, 2022, when Russia greenlit the Galaleya Institute’s Sputnik V inhaled vaccine. The country authorized a similar nasal-drop-based vaccine known as Salnavac on July 4, 2022.

To authorize those vaccines, Russian regulators weighed data from the formerly approved Sputnik V vaccine in conjunction with Phase 1/2 safety and immunogenicity data from the intranasal versions of that vaccine.

More recently, China authorized the inhalable Convidecia Air COVID-19 vaccine from CanS…

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Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

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Startup licenses Harvard tech to develop ultra-sensitive COVID antibody assay

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

New startup Spear Bio plans to commercialize ultrasensitive protein-detection technology from Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Boston-based Spear Bio licensed the DNA nanotechnology-driven Successive Proximity Extension Amplification Reaction (SPEAR) in a worldwide exclusive agreement with Harvard’s Office of Technology Development.

Spear Bio will develop a reagent-based platform for ultrasensitive protein detection in small-volume samples with an initial focus on research-use-only applications, Harvard said in a news release.

RELATED: Here’s where Harvard’s engineering dean sees medtech research going Read more

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U.S. government plans to stop paying for COVID-19 vaccines 

[Pfizer-BioNTech vaccine image courtesy of Wikimedia Commons.]

The Biden administration is in the process of transferring responsibility for COVID-19 vaccines to the healthcare industry, according to media reports.  

To date, the federal government has footed the bill for the shots, but the Trump and Biden administrations have intended to eventually cease that practice as the pandemic shifts to an endemic phase. 

Confirmed COVID-19 cases are declining steadily, reaching levels not seen since mid-May. 

HHS has scheduled a planning session dedicated to COVID-19 drug payments. The agency will invite representatives from pharma companies, pharmacies and state health departments to the meeting. The meeting will cover regulatory matters and treatment for uninsured patients. 

The transition to shifting financial liability for COVID-19 therapies to the private sector could take months, according to …

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FDA issues new COVID-19 testing guidance to avoid false negatives

New at-home COVID-19 antigen testing guidance recommends repeat testing after a negative result. [Image courtesy of Abbott]

COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers.

The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies from people likely infected by the omicron variant shows repeat testing increases the chance of an accurate result, reducing the likelihood of spreading the virus.

“At-home COVID-19 antigen tests detect proteins, called antigens, from the SARS-CoV-2, the virus that causes COVID-19,” the FDA said yesterday. “At-home COVID-19 antigen tests are less likely to detect the SARS-CoV-2 virus than molecular tests, such as polym…

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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

[Photo from Pexels]The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

Get the full story from our sister site, Drug Discovery & Development.

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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

Photo from Pexels

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

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Will COVID-19 vaccines be updated by fall? 

Photo by Frank Meriño from Pexels

FDA advisors are slated to meet to discuss the prospect of updating the first generation of COVID-19 vaccines for use as boosters this fall and winter.

But it remains unclear whether updating the COVID-19 vaccines will be necessary. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) have updated vaccines in the works.

Pfizer and Moderna have both said their next-generation vaccines appear to be more effective against the omicron BA.1 variant. But fighting the growing number of omicron lineages could prove challenging. For example, the recent emergence of BA.4 and BA.5 subvariants threatens those infected with older omicron variants.

Pfizer noted in a press release that it was developing monovalent and bivalent versions of its COVID-19 vaccine, developed jointly with BioNTech. Protection appeared to be substantially stronger against the BA.1 subvariant than the BA…

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Young children in U.S. now eligible for COVID-19 vaccination

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.

FDA authorized the shots for young children on June 17, while CDC did so a day later.

“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”

Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.

“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.

The federal government has also created a webs…

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Florida chooses to not pre-order COVID-19 vaccines for young children

[Image courtesy of Pixabay]

All U.S. states but Florida have pre-ordered COVID-19 vaccine doses for children under the age of 5, according to the Miami Herald. The federal government had a deadline of June 14 for states to pre-order vaccine doses.

In a statement, the Florida Department of Health said it decided not to order vaccine doses for young children because it does not recommend all children receive COVID-19 vaccines.

The statement also criticized the federal government’s COVID-19 track record. “States do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” it read.

Yesterday, an FDA advisory committee unanimously recommended emergency use authorization of COVID-19 vaccines in young children. Members of the committee, however, shared different opini…

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Sanofi-GSK next-generation COVID-19 booster could go head-to-head against revised Moderna and Pfizer offerings

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines.

The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15 days after vaccination. The same vaccine also yielded a 15-fold increase against the original D614 virus and a 30-fold increase against the beta strain.

The results were from two studies, the VAT02 Cohort 2 and COVIBOOST VAT013.

The new vaccine candidate elicited a more robust immune response than the Pfizer-BioNTech booster vaccine or the first-generation Sanofi-GSK vaccine candidate.

Last week, Moderna (Nasdaq:MRNA) also announced that its bivalent omicron booster vaccine candidate, mRNA-1273.214 yielded 1.75 times more neutralizing antibodies t…

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FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients

In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation.

In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally ass…

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