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 assess how the vaccine stacks up against other variants of concern.

In May, Bavarian Nordic announced that a Phase 2 study found that ABNCoV2 induced a solid boost in neutralizing antibodies against the original omicron strain.

The non-adjuvanted ABNCoV2 vaccine candidate uses a virus-like particles (VLP) platform.

Copenhagen, Denmark–based Bavarian Nordic has become best known recently for its monkeypox and smallpox  vaccine. Known as Jynneos in the U.S., the monkeypox vaccine is named Imvanex in Europe and Imvamune in Canada.

Bavarian Nordic’s product portfolio includes…

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Pfizer to test a third dose of COVID-19 vaccine in children 6 months to under 5 years of age

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have found that two 3-µg doses of their BNT162b2 (Comirnaty) vaccine were safe but generated an underwhelming immune response in children aged two to five years old.

PFE shares fell 2.45% to $59.75 in early afternoon trading.

The news could delay vaccine availability for younger children.

As a result, the companies plan on amending a clinical trial to test a third dose of the vaccine at least two months after the second dose.

Pfizer notes that the Phase 1/2/3 study is ongoing and is still blinded.

Pfizer noted that similar clinical data in older age demographics showed higher efficacy with two doses — albeit at higher doses.

On a positive note, a third dose of the vaccine was well tolerated in the trial involving two to five-year-olds.

The companies plan on filing for emergency use authorization in children aged 6 months to under 5 years if the third dose is efficacious. Read more

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Pfizer-BioNTech COVID-19 vaccine 100% effective in adolescents 12 to 15

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose.

The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In addition, clinical trial investigators reported no serious safety concerns in participants in the six months following receipt of the second dose.

Data from 2,228 individuals were included in the analysis.

In the U.S., the Comirnaty vaccine is available under emergency use authorization for adolescents 12 to 15. The FDA approved the vaccine for individuals at least 16 years of age in August. In late October, the companies received emergency use authorization for the vaccine in children 5 to 11.

Pfizer and BioNTech plan on including the recent data in a planned supplemental Biologics License Application (sBLA) t…

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Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Get the full story from our sister site, Drug Discovery & Development.

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Pfizer seeks FDA blessing for COVID-19 vaccine booster

Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older.

The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55.

The latest data indicate that a third dose of the Comirnaty vaccine boosts antibody titers and continues to be well tolerated.

Trial investigators administered the booster between 4.8 and 8 months after giving the second dose of the COVID-19 vaccine.

The booster resulted in strong protection against the original or wild-type strain of SARS-CoV-2. Specifically, 99.5% of participants had a four-fold increase in neutralizing antibody levels after the third dose.

The most common side effects were similar to those from earlier doses, including injection-site soreness, fatigue, headache, muscle aches and chills.

The comp…

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