The Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA), the most widely used vaccine to protect against monkeypox, tends to have generally mild side effects according to clinical trial data. It is also clear that the Jynneos vaccine can help reduce the severity of monkeypox infections. Researchers are uncertain, however, about how the vaccine’s potential to…

FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX). The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old. Individuals in those age groups who have waited…

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…

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) 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…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster. Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters. Last week, the UK approved Moderna’s bivalent COVID-19 vaccine…

EMA’s Emergency Task Force (ETF) has given national authorities in the EU permission to use the Imvanex vaccine as an intradermal injection while supplies of the vaccine remain limited. In a statement, the ETF described the decision as a “temporary measure.” The FDA recently reached a similar decision but authorized the intradermal use of the Imvanex…

The European Medicines Agency (EMA) has begun an evaluation of a conditional marketing authorization application for the Skycovion (GBP510) COVID-19 vaccine candidate from SK Chemicals GmbH. Skycovion is a recombinant protein-based vaccine with adjuvant from GSK. In its filing, SK Chemicals provided data on how efficacious the vaccine is at creating antibodies against ​wild-type COVID-19.…

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…

The Administration for Strategic Preparedness and Response (ASPR) will make 50,000 courses of the small-molecule drug Tpoxx (tecovirimat) from SIGA Technologies (Nasdaq: SIGA) available to help fight the monkeypox outbreak. There have been 13,517 confirmed monkeypox/orthopoxvirus cases in the U.S. to date, according to the CDC. In 2018, Tpoxx became the first drug to win an…

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates. One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant. A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led…

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.  But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.  A variety of companies are developing next-generation COVID-19 vaccines that could potentially…

COVID-19 is an emerging focus for EpicentRx, a private biotech focused on multiple immune-mediated disorders. The La Jolla, California–based company is developing a next-gen COVID vaccine for SARS-CoV-2 based on nucleocapsid rather than spike protein.  The recombinant replication-competent adenoviral vaccine that expresses the SARS-CoV-2 nucleocapsid protein could be more resistant to COVID-19 variants.  The real-world…

Pfizer (NYSE:PFE) said it is planning on filing a supplemental Biologics License Applications (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate in infants by the end of the year. After announcing positive data from a pivotal U.S. Phase 3 study (NCT04382326), the company said the 20vPnC vaccine candidate, if approved, would offer the broadest serotype…

FDA has authorized emergency use of the Jynneos monkeypox vaccine for individuals who face an elevated risk of infection from the virus. The authorization specifically allows the intradermal use of vaccine from Bavarian Nordic A/S (OMX:BAVA, OTC:BVNRY) in those 18 and older with a high risk of monkeypox infection. The agency notes that the intradermal…

Over the past few months, healthcare leaders have been working on identifying vaccines to prevent the spread of monkeypox. One such development is the use of Bavarian Nordic’s (OMX:BAVA) Jynneos vaccine for the prevention and treatment of the fast-spreading disease. The Jynneos vaccine won approval in the U.S. in 2019 for the prevention of monkeypox…

Axcella Therapeutics (Nasdaq:AXLA) has announced positive topline results from a Phase 2a randomized, double-blind, placebo-controlled study of the metabolism-modulator AXA1125 in patients with fatigue from long COVID. The biotech’s Phase 2a study was among the first drug studies to focus on long COVID. In February, FDA granted a Fast Track Designation to AXA1125 to treat…

In the U.S., federal authorities have allowed two vaccines to be used to reduce the risk of monkeypox virus infection. The preferred option is the Jynneos vaccine from Bavarian Nordic (OMX:BAVA), followed by Emergent BioSolutions’ (NYSE:EBS) ACAM2000.  While vaccination efforts are ramping up, California, New York and Illinois have declared states of emergency as the…

The U.S. government will pay $1.74 billion to buy 66 million doses of Moderna’s COVID-19 vaccine made with the new omicron-adapted formula, the drugmaker said today. The government has the option to acquire up to 300 million total doses of the omicron boosters under the agreement. The U.S. last month agreed to buy 105 million…

FDA has signed off on a supplement to the biologics license for Bavarian Nordic’s (OTCMKTS:BVNRY) Jynneos vaccine, which is indicated for both monkeypox and smallpox. The move will make an additional 786,000 doses of vaccine available for use in the U.S. The extra doses are available following an FDA expedited inspection and approval of Bavarian…

Alphabet subsidiary DeepMind has announced that its AI system AlphaFold has predicted the structure of more than 200 million proteins, representing almost every known cataloged protein. In addition, AlphaFold and its partner, the EMBL‘s European Bioinformatics Institute, announced that the recent release expanded the database by more than 200 fold, from almost 1 million to…

As federal officials wax poetic about the prospect of intranasal COVID-19 vaccines and other novel vaccine platforms, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have announced that a randomized Phase 2 study will study an incrementally improved COVID-19 vaccine known as BNT162b5. The updated vaccine candidate includes a modified spike protein designed to bolster immunogenicity…

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…

Pfizer and BioNTech today announced they submitted to the European Medicines Agency (EMA) for an omicron-adapted bivalent COVID-19 vaccine candidate based on the BA.1 sub-lineage. The application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to develop an omicron-adapted bivalent vaccine candidate to address the spread of SARS-CoV-2. Pfizer recently…

First announced in January 2020, Novavax’s (Nasdaq:NVAX) NVX-CoV2373 COVID–19 has won FDA authorization for primary immunization. However, it is presently not authorized as a booster. NVAX shares ticked up 0.27% to $69.95. Novavax is late to the COVID-19 vaccine partner, scoring authorization more than a year and a half after Moderna (NYSE:MRNA) and Pfizer (NYSE:PFE) won emergency use authorization for…

The mRNA-focused biopharma CureVac N.V. (Nasdaq:CVAC) has filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech SE (Nasdaq:BNTX) demanding compensation for infringement of CureVac’s patents. In particular, the lawsuit claims that the four German patents, EP 1 857 122 B1, DE 20 2015 009 961 U1, DE 20 2021 003 575 U1…