COVID-19 vaccine Archives - Medical Design Sourcing

Moderna leans on RSV vaccine, AI and a diversified pipeline to regain competitive edge

Moderna surged to prominence thanks to its rapid development of a competitive COVID-19 vaccine. Since the early days of the pandemic, however, the company has struggled to maintain its momentum. Year-to-date, its stock is down close to 40%, trading around $110 per share.

Adapting to COVID-19 variants

The company hopes that its development of vaccines for the XBB.1.5 COVID-19 variant will help bolster financial performance. “We are now awaiting approval to start for our updated COVID-19 vaccine applications to regulators globally,” Moderna CEO Stéphane Bancel said.

Developing a robust pipeline

Moderna CEO Stéphane Bancel has stressed in the past that Moderna is more than a COVID-19 company. “Our commercial team is also preparing for the 2024 launch of our next respiratory commercial product,” Bancel said. This product in question, a vaccine for respiratory syncytial virus (RSV) could potentially compete against products from GSK and Pfizer, among others.

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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 months through 4 years of age.

The U.S. is presently grappling with a “tripledemic” of COVID-19, flu and RSV, which can each cause respiratory distress in children. Pfizer and BioNTech said today that updated COVID-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would still receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 vaccine. After that, they would receive a third 3-µg dose of the omicron BA.4/BA.5-adapted bivalent vaccine.

Pfizer and BioNTech are seeking a sim…

Study finds no connection between COVID-19 vaccine and shingles

[Image courtesy of Pixabay.]

After the introduction of COVID-19 vaccines, anecdotal evidence linked the administration of the vaccines with herpes zoster (shingles) infection. A new study published in JAMA Network Open, however, concludes that COVID-19 debunks that assertion.

Reviewing data from more than two million U.S. recipients of COVID-19 vaccine, the study authors concluded that the incidence rate ratio of shingles following COVID-19 vaccination was 0.91.

Shingles is caused by the virus that also causes chickenpox.

An incidence rate ratio of less than one indicates that the incidence of shingles in vaccinated individuals is potentially lower than in unvaccinated individuals. The study authors, however, asserted that COVID-19 was “not associated with an increased risk of herpes zoster.”

With a confidence interval of 95%, the study authors estimate that margin of error ranges from 0.…

Pfizer mulls boosting COVID-19 vaccine price to $110 or more per dose

Pfizer (NYSE:PFE) signaled its intent to increase its COVID-19 vaccine price to roughly $110 to $130 per dose after the U.S. government’s purchase program for the vaccine expires, according to Angela Lukin, Pfizer’s global primary care and U.S. president.

The COVID-19 vaccine price hike would pertain to patients 12 and older.

The company could revise the pricing for the vaccine in the first quarter of 2023, assuming the U.S. government transitions COVID-19 vaccination to the private sector by then.

The U.S. government currently pays about $30 per dose for the COVID-19 vaccine from Pfizer and BioNTech (Nasdaq: BNTX).

Pfizer anticipates that private payers would cover the cost of the shots, making them free or nearly so for most individuals.

Demand for COVID-19 vaccines has fallen considerably in 2022, which could compel makers of COVID-19 vaccines to hike prices to meet revenue targets.

Pfizer ultimately anticipates the si…

Pfizer and BioNTech get positive CHMP opinion for updated bivalent BA.4/BA.5-adapted COVID-19 vaccine booster

Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older.

The European Commission will likely make a final decision on the updated vaccine soon.

The updated vaccine has won emergency use authorization in the U.S. for use as a booster.

The new vaccine contains 15-µg of mRNA encoding the spike protein of the original form of SARS-CoV-2 and 15-µg of mRNA encoding the spike protein of the omicron BA.4/BA.5 sublineages.

Earlier this month, Pfizer and BioNatech announced they received a positive CHMP opinion for an omicron BA.1-adapted bivalent COVID-19 vaccine booster.

“Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will ha…

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…

Next-gen Pfizer-BioNTech vaccine candidates fare well in Phase 2/3 study

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates.

One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant.

A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led to a significantly higher immune response against omicron BA.1 than the companies’ original vaccine.

Booster doses of 30 µg and 60 µg generated a robust immune response in the Phase 2/3 study.

In the U.S., the BA.1 variant is responsible for a single-digit percentage of COVID-19 infections.

The company plans on sharing the data with the scientific community and health authorities to accelerate the potential introduction of an omicron-adapted booster “as soon as possible if authorized by regulators,” said Pfizer CEO Dr. Albert Bourla.

“Omicron has ne…

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 effectiveness of spike-protein-based COVID-19 vaccines has generally dipped since their integration as a wave of SARS-CoV-2 variants has emerged.

But while the spike protein mutates frequently, nucleocapsid doesn’t.

“The RNA for the virus is wrapped around it,” said EpicentRx CEO Dr. Tony Reid. “If it mutates and alters its three-dimensional structure very much, the RNA will unwind, and the virus will be nonviable.”

EpicentRx plans to work with partners to take a nucleocapsid-based next-gen CO…

Moderna inks deal with US for up to 300M omicron boosters

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 doses of Pfizer and BioNTech’s updated vaccine for $3.2 billion. That deal similarly includes an option for up to 300 million doses.

Moderna is developing the bivalent vaccine candidate mRNA-1273.222 based on feedback from the FDA. The vaccine incorporates mRNA from the omicron BA.4/5 strain.

“Moderna’s mRNA platform is enabling us to rapidly create mRNA-1273.222, a bivalent vaccine that specifically targets omicron subvariants BA.4 and BA.5, the most prevalent variants of concern in the U.S. today,” Moderna CEO Stéphane Bancel said in a news release.

Scientists are uncertain whether BA.4/BA.5–based v…

Fall 2022 COVID-19 vaccine candidate tracker

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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 optimize the strength and durability of immune protection compared to the first crop of vaccines.

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

White House holds next-gen COVID-19 vaccine summit

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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 could be delivered nasally or via a skin patch, they did not specify where the funding for such efforts would come from.

As the omicron BA.5 lineage has gained momentum, some pundits have called for the government to spur the development of novel vaccines.

The Biden administration hopes to stymie future SARS-CoV-2 variants, curb infection and transmission of the virus and ensure that future vaccines offer longer-lasting protection.

Moderna and Pfizer are both developing bivalent …

HHS and DOD order 3 million doses of Novavax COVID-19 vaccine

Novavax (Nasdaq:NVAX) announced that its protein-based NVX-CoV2373 COVID-19 vaccine could be the first of its type to be available in the U.S., assuming it wins backing from the FDA and CDC.

The U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) have secured 3.2 million doses of Novavax’s COVID-19 vaccine.

There are currently two FDA-approved mRNA vaccines and an authorized adenovirus vector vaccine.

The protein-based Novavax vaccine is built using a more traditional technique than rivals and is adjuvanted to enhance the immune response. Hepatitis B and shingles vaccines are also protein-based and adjuvanted.

The vaccine includes a small amount of the SARS-CoV-2 spike protein.

In June, an FDA advisory committee recommended authorization of the Novavax vaccine.

Typically, FDA grants authorization soon after hearing from its advisors but has not yet authorized the Novavax vaccine.

Novavax note…