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…

Bavarian Nordic A/S (OMX:BAVA) has announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has ordered an additional 2.5 million doses of liquid-frozen Jynneos vaccine. FDA first approved Jynneos, a non-replicating smallpox and monkeypox vaccine, in 2019. It continues to be the only FDA-approved vaccine indicated for monkeypox. The company will begin deliveries…

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from 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…

Pfizer Inc. (NYSE:PFE) has filed a new drug application (NDA) with the FDA for approval of Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for individuals facing a high-risk for progression to severe illness from COVID-19. Paxlovid consists of the SARS-CoV-2 main protease inhibitor nirmatrelvir (PF-07321332) and  the HIV-1 protease inhibitor and CYP3A inhibitor ritonavir. Because…

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine.  The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the…

The biopharma Icosavax (Nasdaq:ICVX) has announced positive topline interim results from its Phase 1/1b clinical trial of IVX-121, a vaccine candidate with a prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen. The Phase 1 portion of the study enrolled 90 healthy young adults between 18 and 45. The Phase 1b portion included 130 healthy adults…

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…

Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir. The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral…

GSK plc (LSE/NYSE:GSK) and Sanofi (EPA:SAN) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study. For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron. The vaccine is based on the original D614 virus and the beta (B.1.351) strain.…

GSK plc (NYSE:GSK) has announced its plans to spend £1 billion over the next ten years on R&D focused on infectious diseases that disproportionately affect lower-income countries. Diseases covered in the research will include malaria, tuberculosis, HIV, neglected tropical diseases (NTDs) and antimicrobial resistance (AMR). The HIV focus will be through ViiV Healthcare, a joint…

After struggling to find support for its inactivated whole-virus COVID-19 vaccine candidate VLA2001, French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has received a €90.5 ($95) million investment from Pfizer (NYSE:PFE), which amounts to 8.1% of the company’s share capital at a price of €9.49 per share. The Saint-Herblain, France–based company plans on using the…

Merck & Co. (NYSE: MRK) has announced that the Vaxneuvance pneumococcal 15-valent conjugate vaccine has won approval for children 6 weeks through 17 years of age. The vaccine is indicated to protect against infection from Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F. The…

European Medicines Agency (EMA) has begun a rolling review for updated versions of Moderna’s and Pfizer/BioNTech’s vaccines modified to optimize protection against newer variants of SARS-CoV-2. Earlier this month, Moderna (Nasdaq:MRNA) announced that its Omicron-containing bivalent COVID-19 booster candidate, mRNA-1273.21, provided an antibody response that was statistically superior to the original version of the vaccine,…