The current mRNA vaccines from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE)/BioNTech (Nasdaq:BNTX) stimulate the production of neutralizing antibodies that bind to the spike protein of SARS-CoV-2. But there is a novel mRNA vaccine that activates T cells to attack cells infected with the virus. Developed by researchers at MIT and other institutions, the new vaccine could…
Pfizer seeks EUA for omicron booster for under-5 kids
Pfizer (NYSE: PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq: BNTX) today announced they’ve submitted a EUA application with the FDA for an omicron COVID-19 booster for children under 5. The companies are seeking authorization for their omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6…
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…
Moderna says Pfizer-BioNTech COVID vaccine infringed its patents
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…
Fall 2022 COVID-19 vaccine candidate tracker
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…
A next-gen vaccine that could help end COVID-19 whack-a-mole
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…
FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall
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…
FDA authorizes Moderna and Pfizer-BioNTech COVID-19 vaccines in young children
Until recently, the Pfizer-BioNTech COVID-19 vaccine was available for all individuals 5 years of age and older, while the Moderna vaccine was authorized for individuals at least 18. Now, the FDA has authorized the use of both vaccines in children from 6 months to four years old. In addition, the agency also agreed to allow…
Moderna’s omicron bivalent COVID-19 vaccine outperformed original vaccine in analysis
Moderna (Nasdaq:MRNA) has announced that its omicron-containing bivalent COVID-19 booster candidate mRNA-1273.214 yielded 1.75 times more neutralizing antibodies than its FDA-approved mRNA-1273 vaccine. The company also noted that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against the omicron variant roughly eight times over baseline levels in the primary immunogenicity study. The…
Moderna’s first bivalent COVID-19 vaccine booster candidate shows promise
Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study. The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron. The company notes that the mRNA-1273.211 booster outperformed the first-generation…
FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11
The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said…
AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID
RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2. “Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral…
Pfizer ticks up on Street-beating Q1, lessens full-year guidance
Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…
SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea
SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate. The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant. SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in…
Moderna says bivalent COVID-19 boosters could offer more robust protection against variants
Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine. A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.…
BioNTech 2021 revenue surges 39x year over year
The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021. Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth. Net revenues of the vaccine between Pfizer and BioNTech surpassed $59 billion. In 2020, BioNTech’s revenues were €482.3 million. “Looking back, 2021 was…
CureVac launches Phase 1 study for next-gen mRNA COVID-19 vaccine
CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have launched a Phase 1 dose-escalation study to test the performance of CV2CoV, a COVID-19 vaccine candidate based on CureVac’s second-generation mRNA backbone. In late morning trading, CureVac’s stock ticked up 0.10% to $19.22. CVAC shares were trading above $100 before announcing in mid-June 2021 that the…
FDA amends EUA for SARS-CoV-2 antibody sotrovimab
GlaxoSmithKline plc (LSE/NYSE:GSK) and Vir Biotechnology (Nasdaq:VIR) have announced that FDA has concluded that the investigational monoclonal antibody sotrovimab is unlikely to be effective against the omicron BA.2 subvariant, which will soon dominate the U.S. FDA has amended the Emergency Use Authorization (EUA) Fact Sheet for sotrovimab and its website to exclude the antibody in…
Icosavax stock tanks after announcing disappointing interim SARS-CoV-2 Phase 1/2 results
Icosavax (Nasdaq:ICVX) saw its stock skid 65.5% to $4.26 in mid-day trading after announcing interim results from an ongoing Phase 1/2 trial of IVX-411, a virus-like particle vaccine candidate against SARS-CoV-2. After going public last July, the company’s stock hit a peak of $39.73 on September 3. Initial data from IVX-411 was comparable or below…
Moderna shares R&D updates at third annual vaccines day
Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old.…
Moderna seeks FDA blessing for second COVID-19 vaccine booster
Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine. Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older. In its submission, Moderna included data gathered…
Moderna says its mRNA Access program could help with the next pandemic
Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases. “It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships. “mRNA Access was…
Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults
Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older. The two companies submitted two real-world data sets from Israel while the omicron variant was widespread. Pfizer notes that an additional dose…
Valneva anticipates EMA nod for its COVID-19 vaccine candidate in April
French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has sent the company a “small set” of questions related to its VLA2001 COVID-19 vaccine candidate. The firm announced on February 25 that CHMP had sent the company a…
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…