COVID-19 vaccine Archives - Page 4 of 38

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 interim vaccine efficacy of its first mRNA COVID-19 vaccine candidate was 47% in a Phase 2b/3 study.

Tübingen, Germany–based CureVac believes that its second-generation mRNA could prove to be broadly efficacious against SARS-CoV-2 variants and other pathogens.

Nature published a preclinical study involving cynomolgus macaques last year, indicating that the immunogenicity of CV2CoV was superior to its first-generation vaccine candidate, CVnCoV. The paper concluded that CV2CoV was “comparably immunogenic to the BNT162b2 (Pfizer) vaccine in macaques.”

The dose of the CV2CoV vaccine…

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 certain areas.

GSK and Vir were initially optimistic about the antibody’s ability to target the mutations in the spike protein of the original omicron SARS-CoV-2 variant.

Vir shares dropped 13.56% to $21.81. GSK shares were mostly flat, falling 0.046% to $43.28.

The market for SARS-CoV-2 antibodies has been competitive, but emerging variants have limited use of the therapies.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended marketing authorization for AstraZeneca’s (LON:AZN) Evushe…

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 human convalescent sera control in previously unvaccinated individuals.

Three weeks after receiving the second vaccine dose, participants’ responses were up to 154 IU/mL across dosage groups in the live virus neutralization assay and up to 592 BAU/mL across groups in the spike IgG assay. The corresponding human convalescent sera control figures were 281 IU/mL and 361 BAU/mL, respectively.

In previously vaccinated participants, an IVX-411 booster drove up neutralizing antibody titers 5x to 599 IU/mL for wild-type virus after 28 days. For the omicron variant, neutralizing antibody titers were a…

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. Efficacy fell to 37.5% in children aged 2 to 6.

As part of a series of Vaccine Day–themed announcements, the company said it is making progress with global regulatory submissions for the mRNA-1273 in younger children. The company hopes to receive authorization for a 25 μg two-dose primary series of the COVID-19 vaccine.

In addition, the company is vying to get FDA authorization for children 6 to 12 years old. The shot is already approved for that demographic in Europe, Canada and Australia.

In addition, an interim analysis of a Phase 2 study of influenza vaccine candidate mRNA-1010 found no significant safety concerns. Furthermo…

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 from the U.S. and Israel after the emergence of the omicron variant.

Data on the efficacy of a fourth dose of Moderna’s vaccine against omicron were recently published in NEJM. The researchers, considering data from the Moderna and Pfizer-BioNTech vaccines, concluded that a fourth dose of mRNA vaccine appears to be “immunogenic, safe, and somewhat efficacious (primarily against symptomatic disease).”

In January, early data from Israel’s Sheba Medical Center indicated that an additional booster of COVID-19 vaccine from Pfizer and BioNTech drove to a fivefold increase in antibodi…

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 of the BNT162b2 vaccine enhanced protection against infections and severe illness.

One dataset involved patient records from the Israeli Ministry of Health involving more than 1.1 million adults at least 60 years old with no known prior COVID-19 infection eligible for a fourth dose booster. That data suggested that individuals receiving an additional dose were half as likely to be infected and had one-fourth the risk of contracting severe illness than those who had received a single booster.

The companies also submitted data from an ongoing, open-label, non-randomized study focused on healthcare w…

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 series of questions as part of its initial assessment, to which it responded within two working days.

It anticipates that it can swiftly respond to the latest batch of questions.

Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022.

In such a case, the company would supply European countries with the vaccine in the second quarter of the year.

Valneva has an agreement with the European Commission to provide up to 60 million doses of the vaccine over two years.

The company says t…

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.

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.

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 particles.

The Health Canada approval covers adults between the ages of 18 to 64.

The agency approved the Novavax COVID-19 vaccine last week.

GSK is also working with K Bioscience in South Korea on an adjuvanted COVID-19 vaccine and with CureVac on a next-generation mRNA vaccine.

“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect peopl…

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 European Medicines Agency (EMA).

In a Phase 3 efficacy trial, two doses of the vaccine in seronegative individuals were 100% effective against severe COVID-19 disease and hospitalization. Protection against moderate or severe COVID-19 was 75%, while protection against symptomatic COVID-19 was 57.9%.

A booster dose of the vaccine increased neutralizing antibodies 18- to 30-fold in recipients of mRNA and adenovirus vaccines.

The companies note that the research was carried out while challenging variants of concern were circulating. “No other global Phase 3 efficacy study…

FDA reportedly mulling authorizing fourth COVID-19 vaccine dose

[Image courtesy of Wikipedia]

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 FDA allows the broader public to obtain an additional dose, the agency would require data demonstrating the ability of a fourth dose to boost immunity.

At present, however, it remains unclear whether the agency would recommend first-generation vaccines or recommend a variant-specific version.

Pfizer, BioNTech and Moderna are working on omicron-based boosters.

CDC currently recommends all individuals who are at least 12 to obtain three doses of mRNA COVID-19 vaccine…