COVID-19 vaccines Archives - Page 2 of 24

Young children in U.S. now eligible for COVID-19 vaccination

Some 18 months after adults became eligible for COVID-19 vaccines, children between 6 months to 4 years old can now be vaccinated in the U.S.

FDA authorized the shots for young children on June 17, while CDC did so a day later.

“The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old,” said President Joe Biden in a press briefing. “And for the first time in our fight against this pandemic, nearly every American can now have access to life-saving vaccines.”

Biden noted that the U.S. government had ample supplies of vaccines for young children and had coordinated with states, local health centers, pharmacies and pediatricians to help administer the shots.

“My administration, with the help of the CDC, has been planning and preparing for this moment for a long time,” Biden said.

The federal government has also created a webs…

Florida chooses to not pre-order COVID-19 vaccines for young children

[Image courtesy of Pixabay]

All U.S. states but Florida have pre-ordered COVID-19 vaccine doses for children under the age of 5, according to the Miami Herald. The federal government had a deadline of June 14 for states to pre-order vaccine doses.

In a statement, the Florida Department of Health said it decided not to order vaccine doses for young children because it does not recommend all children receive COVID-19 vaccines.

The statement also criticized the federal government’s COVID-19 track record. “States do not need to be involved in the convoluted vaccine distribution process, especially when the federal government has a track record of developing inconsistent and unsustainable COVID-19 policies,” it read.

Yesterday, an FDA advisory committee unanimously recommended emergency use authorization of COVID-19 vaccines in young children. Members of the committee, however, shared different opini…

Sanofi-GSK next-generation COVID-19 booster could go head-to-head against revised Moderna and Pfizer offerings

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) have announced that their next-generation COVID-19 booster vaccine candidate based on the beta variant yielded a substantial immune boost in adults previously primed with mRNA vaccines.

The novel vaccine yielded a strong increase in antibody titers above baseline against various variants of concern, including a 40-fold increase against the BA.1 omicron subvariant 15 days after vaccination. The same vaccine also yielded a 15-fold increase against the original D614 virus and a 30-fold increase against the beta strain.

The results were from two studies, the VAT02 Cohort 2 and COVIBOOST VAT013.

The new vaccine candidate elicited a more robust immune response than the Pfizer-BioNTech booster vaccine or the first-generation Sanofi-GSK vaccine candidate.

Last week, Moderna (Nasdaq:MRNA) also announced that its bivalent omicron booster vaccine candidate, mRNA-1273.214 yielded 1.75 times more neutralizing antibodies t…

FDA considers possible myocarditis link in Novavax COVID-19 vaccine recipients

In reviewing clinical trial data related to the Novavax (Nasdaq:NVAX) COVID-19 vaccine, FDA expressed concerns about the product’s potential to cause myocarditis, a type of heart inflammation.

In a briefing document, FDA noted that the “identification of multiple potential vaccine-associated cases in a premarket safety database of ~40,000 vaccine recipients raises concern.” The agency goes on to say that if causally associated, “the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines (for which no cases were identified in pre-authorization evaluation).”

In a statement, Novavax concluded that the rate of myocarditis and a similar condition known as pericarditis was similar across vaccine and placebo recipients. In the vaccine arm, 0.007% experienced such heart inflammation, while 0.005% of placebo recipients did.

Myocarditis is a risk occasionally ass…

Emergent hid quality problems from FDA, House report concludes

A new Congressional report concluded that Emergent BioSolutions (NYSE:EBS) attempted to hide evidence related to quality problems before informing the FDA that 15 million COVID-19 vaccines were contaminated.

Prepared for Rep. Carolyn Maloney (D-NY) and James E. Clyburn (D-SC), the report from the House and the Select Subcommittee on the Coronavirus Crisis scrutinizes the quality controls in Emergent’s Bayview plant in Baltimore.

In particular, the House report concluded that Emergent workers removed quality-assurance “hold” tags from Johnson & Johnson vaccine batches before an FDA inspection.

The Bayview plant had served as the only U.S. manufacturing site for the J&J COVID-19 vaccine.

The report relies on internal communications from Emergent executives to determine whether the company attempted to elude government oversight.

It also noted that the FDA, J&J and AstraZeneca employees identified problems at the …

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

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

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…

AstraZeneca’s Evusheld offered strong protection against COVID-19 in Phase 3 study

In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo.

The drug is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19.

Evusheld won a EUA in December 2021.

The adults enrolled in the trial had an inadequate response to COVID-19 vaccination, an elevated risk of exposure to SARS-CoV-2 or both. Subjects were either obese, immunocompromised, had pre-existing health conditions such as heart failure or chronic kidney disease, or were 60 years of age or older.

After receiving a single 300 mg intramuscular dose of Evusheld, concentrations of the drug remained elevated for six months after administration, according to a pharmacokinetic analysis.

Th…

An Amazon cloud conversation with AWS Chief Medical Officer Taha Kass-Hout

Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.

This conversation has been edited for clarity and length.

MDO: What d…

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.

The company continues to develop a vaccine known as mRNA-1273.214 with more omicron-specific mutations. That vaccine candidate is now in a Phase 2/3 clinical trial. The company expects data from that trial to be available in the second quarter.

Moderna has published data related to the mRNA-1273.211 candidate as a preprint study in Research Square.

The company continues to bet that its bivalent booster candidate, mRNA-1273.214, will find use as a booster in autumn 2022 in the Northern Hemisphere.

In any event, the mRNA-1273.211 …

Developing nations shun AstraZeneca’s COVID-19 vaccine

A number of developing nations have refused tens of millions of doses of AstraZeneca’s COVID-19 vaccines, according to a report from Reuters.

The countries had received doses of the AstraZeneca vaccine from the COVAX initiative, a global project that focuses on ensuring equitable access to COVID-19 vaccines.

COVAX has distributed 1.4 billion shots to 144 nations to date.

Some countries that COVAX serves indicated a preference for vaccines with a longer shelf life than AstraZeneca’s COVID-19 vaccine.

Last week, COVAX and the African Union also declined to order vaccine doses from Moderna, according to Reuters.

AstraZeneca’s COVID-19 Vaxzevria has a shelf life of six months, but doses are sometimes delivered weeks before the expiration date, Reuters reported.

In related news, Japan recently canceled a purchase of 40 million doses of the AstraZeneca vaccine, according to The Japan Times.

The country has expressed a preference for…

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) in the UK have already approved COVID-19 vaccines from Moderna, AstraZeneca, Janssen and Novavax vaccines. The latter two are, however, not currently in use in the UK.

Valneva vaccine vials

MHRA is the first regulatory agency to approve the Valneva vaccine, an inactivated whole-virus vaccine.

MHRA indicated that the vaccine design may spur a more comprehensive immune response than vaccines solely targeting the SARS-CoV-2 spike protein.

The Valneva vaccine is also stable when stored at standard refrige…