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.…
UK regulators approve Valneva’s COVID-19 vaccine
A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom. Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April. Officials at the Medicines and Healthcare products Regulatory Agency (MHRA)…
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…
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…
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…
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…
Medicago and GSK win approval from Health Canada for adjuvanted plant-based COVID-19 vaccine
GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine. Known as Covifenz, the vaccine makes use of plant-based virus-like…
Sanofi and GSK aim to commercialize COVID-19 vaccine
In the U.S., Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE) continue to dominate the COVID-19 landscape while demand for Johnson & Johnson’s (NYSE:JNJ) vaccine remains limited. Now, Sanofi (NASDAQ:SNY) and GSK (NYSE:GSK) are preparing to get into the game by preparing their regulatory submissions for their COVID-19 vaccine. The companies are currently communicating with the FDA and…
FDA reportedly mulling authorizing fourth COVID-19 vaccine dose
Officials at the Food and Drug Administration are considering potentially authorizing an additional booster of the COVID-19 vaccines from Moderna (NASDAQ:MRNA) as well as Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), according to the Wall Street Journal. At present, individuals 12 and older who are moderately or severely immunocompromised are eligible for four COVID-19 vaccine doses. Before the…
Pfizer-BioNTech omicron-based vaccine may be delayed
Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-specific version of their COVID-19 vaccine. The two companies initially vowed to launch the updated vaccine by the end of March, but that goal may shift depending on the volume of clinical data regulators demand, according to BioNTech. In…
FDA hits pause on COVID-19 vaccine for children under 5
FDA may wait several months before deciding to authorize a COVID-19 vaccine for children between the ages of 6 months to 4 years. The agency had planned on adjourning a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 15 to discuss the potential use of the vaccine in younger children.…
Omicron-specific mRNA vaccine elicited similar protection as original in early primate study
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…
FDA could authorize Pfizer-BioNTech vaccine for young children in late February
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have begun a rolling submission for the BNT162b2 vaccine for children ages 6 months to 4 years. The FDA requested that Pfizer apply for emergency authorization for that age group, according to media reports. The agency is awaiting data from a third dose of the vaccine in the age group,…
Study bolsters case that vaccines protect against long-COVID
It may be too soon to know how often the omicron variant is associated with so-called long-COVID, but research from the Leavitt Partners’ COVID-19 Patient Recovery Alliance confirms that vaccination protects against the condition. Those who received at least one authorized COVID-19 vaccine dose before diagnosis were between seven and 10 times less likely to…
Moderna commences Phase 2 study of omicron-specific booster
Mere days after rivals Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced the launch of a study testing an omicron-based booster vaccine candidate, Moderna (NSDQ:MRNA) has announced its own trial of an omicron-specific vaccine. The vaccine booster candidate, mRNA-1273.529, will be the subject of a Phase 2 study involving approximately 600 participants divided into two cohorts. The…
Pfizer and BioNTech test omicron-specific COVID-19 vaccine in adults
With COVID-19 cases continuing to hover near record levels, Pfizer (NYSE:PFE) and partner BioNTech SE (NSDQ:BNTX) have launched a clinical trial to test an omicron-based vaccine candidate in adults ages 18 to 55. The study will enroll 1,420 participants divided into three cohorts. The first cohort will have already received two doses of the initial…
Valneva shares surge 30% after announcing its vaccine candidate neutralized omicron in neutralizing antibody study
Valneva SE (NSDQ:VALN) announced promising preliminary lab results involving recipients of its inactivated VLA2001 COVID-19 vaccine. In a pseudovirus neutralization assay involving sera from 30 volunteers in the Phase 1/2 trial VLA2001-201, all samples had neutralizing antibodies against the ancestral virus and the delta variant. In addition, 87% (26 samples) had neutralizing antibodies to omicron.…
Bharat Biotech’s Covaxin COVID-19 vaccine booster holds its own against omicron and delta variants
Bharat Biotech (Hyderabad, India) and its partner Ocugen (NSDQ:OCGN) have announced that their Covaxin (BBV152) COVID-19 vaccine candidate generated a strong neutralizing antibody response to the omicron (B.1.529) and delta (B.1.617.2) variants. The data comes from a study at Emory University involving sera from participants who received three doses of the vaccine with a 28-day…