Omicron Archives - Medical Design Sourcing

HHS awards more than $1 billion to advance next-gen COVID-19 vaccines and therapeutics

The U.S. Department of Health and Human Services (HHS) has awarded $1.4 billion to support vaccine clinical trials to test new, more effective and longer-lasting COVID-19 vaccines. In all, Project NextGen is a $5 billion initiative from Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the program is to identify and address strengths and weaknesses of current COVID-19 therapies and vaccines, as well as the back the development of next-gen COVID-19 vaccines and therapies

The latest funding announcement announced allots $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody and another $100 million to spark innovation of novel vaccine and therapeutic technologies.

Towards next-gen COVID-19 vaccines and therapies

Regeneron alone received $326 million under the program, dubbed Project NextGen. The funding for the Tarrytown, New York–bas…

Bavarian Nordic launches Phase 3 clinical study of COVID-19 booster candidate

Bavarian Nordic (OMX:BAVA) has dosed the first subject in a Phase 3 clinical study of the COVID-19 vaccine candidate ABNCoV2.

The study will test whether ABNCoV2 is non-inferior to Comirnaty from Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) in terms of neutralizing antibodies it produces against the original strain of SARS-CoV-2. Secondary endpoints in the study will assess how the vaccine stacks up against other variants of concern.

In May, Bavarian Nordic announced that a Phase 2 study found that ABNCoV2 induced a solid boost in neutralizing antibodies against the original omicron strain.

The non-adjuvanted ABNCoV2 vaccine candidate uses a virus-like particles (VLP) platform.

Copenhagen, Denmark–based Bavarian Nordic has become best known recently for its monkeypox and smallpox vaccine. Known as Jynneos in the U.S., the monkeypox vaccine is named Imvanex in Europe and Imvamune in Canada.

Bavarian Nordic’s product portfolio includes…

FDA reportedly will soon authorize updated COVID-19 boosters

The FDA is on the verge of authorizing updated COVID-19 boosters without the benefit of Phase 3 clinical trial data, according to media reports.

The bivalent boosters, based on the omicron sublineages BA.4 and BA.5 and the original form of SARS-CoV-2, could be available soon after Labor Day.

To authorize the omicron-specific COVID-COVID-19 boosters, FDA will likely review data from the first-generation mRNA COVID-19 vaccines, investigational omicron-specific boosters based on the BA.1 variant and preclinical research.

Moderna (Nasdaq:MRNA) is developing an updated COVID-19 vaccine, as are Pfizer (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX).

The agency hopes the boosters will offer a similar level of protection against SARS-CoV-2 that COVID-19 vaccines provided when they were first authorized in late 2020. At that point, the novel coronavirus had mutated relatively little, resulting in strong vaccine-induced immunity.

The emergence of m…

White House holds next-gen COVID-19 vaccine summit

Image courtesy of Wikipedia

The federal government continues to work closely with notable COVID-19 manufacturers, including Moderna and Pfizer, hosting a summit today focused on the future COVID-19 vaccines.

“We need a vaccine that can stand up to multiple variants,” said White House Covid-19 Response Coordinator Ashish Jha.

While White House officials called for developing inexpensive novel vaccines that could be delivered nasally or via a skin patch, they did not specify where the funding for such efforts would come from.

As the omicron BA.5 lineage has gained momentum, some pundits have called for the government to spur the development of novel vaccines.

The Biden administration hopes to stymie future SARS-CoV-2 variants, curb infection and transmission of the virus and ensure that future vaccines offer longer-lasting protection.

Moderna and Pfizer are both developing bivalent …

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.

VRBPAC backs adding omicron-component to COVID-19 boosters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters.

Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines.

“I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for the potential need for boosters in the fall,” said VRBPAC member Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at CDC.

“Over the coming months, I think we’ll get a sense, and there’ll be plenty of time for debate over who is most appropriate for boosters,” said CBER director Dr. Peter Marks.

Omicron and its subvariants such as BA.2, BA.4 and BA.4 continue to drive the bulk of COVID-19 infections.

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Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11.

The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant and wild-type strain of SARS-CoV-2 compared to two doses. In particular, a sub-analysis of 30 sera from the Phase 2/3 study indicated that a third dose resulted in a 36-fold increase in neutralizing antibody titers for the omicron variant compared to two doses.

The Phase 2/3 clinical trial analysis included data from 140 children aged 5 through 11 years old who received three 10-µg doses of vaccine. In addition, participants received a booster dose approximately six months after a two-dose primary series.

Pfizer and BioNTech intend to seek emergency use authorization (EUA) for a booster dose in the near future and sha…

FDA further limits use of GSK’s and Vir’s SARS-CoV-2 antibody sotrovimab

As the omicron BA.2 subvariant has spread, FDA has announced that it will further constrain the use of the investigational monoclonal antibody sotrovimab. The agency announced that it would limit the use of the antibody in some U.S. regions last week.

GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) were initially confident that the antibody could hold up to the first omicron subvariant, but the companies have concluded that it is probably ineffective against the BA.2 subvariant.

The FDA has announced that sotrovimab is not currently authorized in areas where the BA.2 subvariant makes up the majority of COVID-19 infections. These areas include the Northeast, much of the Western part of the country and a portion of the Midwest.

The FDA has also withdrawn authorization for sotrovimab in Alaska and major U.S. territories, including Puerto Rico.

Last year, FDA similarly limited the use of Lilly’s bamlanivimab (LY-CoV555)…

Pfizer-BioNTech vaccine moderately effective against omicron in children

The Pfizer-BioNTech COVID-19 vaccine lowered the incidence of omicron-based SARS-CoV-2 infection by 31% in children aged 5 to 15 in a recent study.

The vaccine was more effective in children between the ages of 12 and 15, lowering the risk of omicron infection by 59%, according to the study from CDC and Abt Associates.

Participants in the study received two doses of the vaccine.

The Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study incorporated real-world data and also gauged vaccine effectiveness against the delta variant.

Studying weekly nasal swab and survey data from 1,346 children in Arizona, Florida, Texas and Utah, researchers were able to capture mild infections.

“Other pediatric vaccine effectiveness studies relied on lab testing data or health records and generally captured only cases where a child had symptoms and received health care,” said Lauren Olsho, the PROTECT study’s principal investi…

Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq:BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

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

Pfizer plans to share data on fourth dose of COVID-19 vaccine with FDA

COVID-19 vaccine heavyweight Pfizer (NYSE:PFE) will soon provide data related to the fourth dose of its COVID-19 vaccine, according to Bloomberg.

The company and its partner BioNTech (Nasdaq: BNTX) are also developing an omicron-specific version of the vaccine.

Pfizer CEO Dr. Albert Bourla said that the data to be shared with FDA involve the fourth dose of its original COVID-19 vaccine and a new formulation intended to protect against multiple SARS-CoV-2 variants.

Data related to the omicron-specific version are not yet available.

Pfizer also said that clinical trial data involving children under 5 who received three doses of its COVID-19 vaccine would be available in April.

A small Israeli study summarized in Nature last month indicated that a fourth vaccine dose provides a modest increase in antibodies.

Omicron-specific mRNA vaccine elicited similar protection as original in early primate study

A scanning electron microscope image shows SARS-CoV-2 (yellow). Credit: NIAID-RML

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine.

In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.

The study involved a total of eight macaques who received two initial 100-μg doses of the mRNA-1273 vaccine. Nine months after the second dose, four primates received a dose of the existing vaccine, while the remaining four received the omicron-based version.

The study authors performed a challenge test, exposing the non-human primates to the omicron variant to gauge their immune response. The researchers ultimately concluded that both…