COVID-19 vaccines Archives - Page 19 of 24

Emergent has reportedly had serious problems at Baltimore vaccine plant

Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times.

Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, which relied on previously undisclosed internal documents and interviews with current and former federal officials and former company workers.

Johnson & Johnson (NYSE:JNJ) this week announced that it will assume full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility — news that came days after the disclosure that a factory error resulted in 15 million discarded COVID-19 vaccines.

The New York Times — citing internal logs, a government official and a former company supervisor — claims that contamination or suspect…

Johnson & Johnson to test COVID-19 vaccine in adolescents

Mass-vaccination efforts are ramping up, and prominent COVID-19 vaccine developers are working to lower the eligibility age for their products. Johnson & Johnson (NYSE:JNJ), for instance, has begun vaccinating adolescents in a Phase 2a clinical trial for its COVID-19 vaccine candidate.

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) recently announced that their vaccine was 100% effective in a study involving 12-to-15 year-olds. FDA has already authorized its vaccine for patients 16 or older.

Moderna (NSDQ:MRNA) announced plans to launch a Phase 2/3 study known as TeenCove that will test its COVID-19 vaccine in adolescents aged 12 to 18.

Johnson & Johnson’s recent announcement shared its plans to extend its randomized, double-blind, placebo-controlled Phase 2a study (VAC31518COV2001) to adolescents.

The study had previously intended to evaluate the reactogenicity and immunogenicity of its Ad26.COV2.S vaccine after administering it in a vari…

Moderna begins study on variant-specific COVID-19 vaccine

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) is beginning a new Phase 1 study to test the effectiveness of a new version of its COVID-19 vaccine designed to enhance protection against the B.1.351 first detected in South Africa.

The recent study will help Moderna and its partner, the National Institute of Allergy and Infectious Diseases determine whether to update the vaccine.

Moderna had announced its plans to launch the study in January.

In February, the company announced that it had completed manufacturing of a variant-specific vaccine candidate, known as 1273.351. Moderna anticipates that the clinical trial will be fully enrolled by the end of April.

The B.1.351 variant has similar mutations to other variants of concern spotted in the U.K. and Brazil.

The study will enroll approximately 210 healthy adults in four centers across the U.S.

Modern…

‘Double mutant’ coronavirus variant emerges in India and California

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

The number of concerning SARS-CoV-2 variants continues to increase. One notable example is a variant known as a ‘double mutant’ that arose in India. The variant has two mutations that could make the virus more virulent and resistant to antibodies, according to a preprint on bioRxiv.

Researchers at the Stanford Clinical Virology Lab recently confirmed the presence of the variant in California.

There is circumstantial evidence in India that the variant is more infectious because it is responsible for 20% of cases in the Indian state of Maharashtra, where cases have ballooned by more than 50% in the past week.

There is also a theoretical basis for the …

Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months

The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine

The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 COVID-19 vaccine was effective for at least 90 days after the second dose.

Pfizer plans on releasing more data related to the long-term vaccine immunogenicity in the coming weeks.

Pfizer and BioNTech plan on doing two years of follow-up for their Phase 3 vaccine trial.

Earlier this year, the two companies released data indicating that their vaccine also remains effective against a highly-transmissible SARS-CoV-2 variant first identified in South Africa.

Pfizer and BioNTech are also testing the vaccine on adolescents. Recent data suggest that the vaccine is 100% effective in ad…

Pfizer and Moderna COVID-19 vaccines 90% effective in real-world study

[Photo by Daniel Schludi on Unsplash]

A single dose of Pfizer or Moderna vaccine is about 80% effective at preventing COVID-19 infection at least two weeks after injection. The efficacy level rises to 90% two weeks after the second dose of either mRNA vaccine, according to a recent CDC study involving roughly 4,000 essential workers.

In contrast to the Phase 3 trials from Pfizer-BioNTech and Moderna, the CDC study analyzed vaccines’ ability to prevent COVID-19 infection. Study participants underwent weekly COVID-19 testing for 13 consecutive weeks.

Conversely, the Pfizer-BioNTech and Moderna Phase 3 trials sought to analyze their vaccines’ ability to prevent symptomatic COVID-19 disease. Participants in the Pfizer had to have at least one COVID-19 symptom before they received a SARS-CoV-2 test. Study volunteers in the Moderna trial had to have at least two systemic symptoms or one respiratory symptom …

Johnson & Johnson to provide 220M COVID-19 vaccine doses to African Union

Flag of the African Union

Johnson & Johnson (NYSE:JNJ) announced today that it has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make 220 million COVID-19 vaccine doses available to the 55 African Union member countries.

AVAT also has the potential to order an additional 180 million doses to bring the total to 440 million through 2022. J&J’s move comes as experts increasingly warn that the rollout of COVID-19 vaccine must be truly global — and not too focused on wealthy countries. Otherwise, the pandemic could stretch on for years as new virus variants increasingly crop up in poorer countries.

J&J is also supporting COVAX, a global initiative to provide vaccine doses to developing countries.

“From the beginning of this pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe, and we have been committed to equit…

India curbs COVID-19 vaccine exports as infections rise

Image courtesy of Unsplash

After the number of COVID-19 infections began to incline steeply, India has decided to retain most of the vaccines produced in the country.

The country has also announced plans to lower the eligibility requirements to all citizens 45 or older starting April 1.

The Serum Institute of India is one of the world’s biggest vaccine manufacturers, and is a central producer of the AstraZeneca vaccine, having exported more than 60 million doses. The status of the country as a vaccine producer has been elevated in recent months as AstraZeneca plans in Europe have grappled with production problems.

India-based Bharat Biotech has also developed a COVID-19 vaccine although demand for the vaccine has been low outside of the country.

Vaccinations in India have lagged behind many other countries — the country has exported more doses than it has administered. To date in the co…

Why COVID-19 vaccines could use regular tweaking — for now

Electron microscopic image from the first confirmed case of SARS-CoV-2 in the U.S. Image from CDC.

Influenza viruses are a moving target, forcing drug developers to modify their products annually based on the strains most likely to dominate a given season.

SARS-CoV-2 could follow a similar trajectory in the first few years of the pandemic, according to a study published in Virus Evolution. SARS-CoV-2 is likely to continue to accumulate changes in the receptor binding domain of the spike protein, prompting updates to vaccines over time.

But assuming COVID-19 infection rates are relatively low over the next several years, vaccines are likely to need less-frequent updating, they concluded.

The researchers from the Charité–Universitätsmedizin Berlin in Germany arrived at their conclusions by studying how two other human coronaviruses have evolved over the past four decades. The coronaviruses they s…

AstraZeneca doubles down on COVID-19 vaccine performance

After a quarrel with its independent data safety monitoring board, AstraZeneca confirmed that its COVID-19 vaccine offers strong performance in protecting against COVID-19 in a U.S. study.

The company announced that the vaccine was 76% effective against symptomatic COVID-19. That figure was three points lower than the percentage it released on Monday. The data safety monitoring board had accused the company of cherry-picking data to inflate its efficacy rating. The 76% efficacy figure of the two-shot vaccine is marginally higher than that of the one-dose Johnson & Johnson vaccine. The J&J vaccine was 72% effective in the U.S. and 66% globally.

The 76% efficacy rate for AstraZeneca’s vaccine reflects a more recent validation of the study’s statistical analysis, including COVID-19 cases reported later in the trial.

The data is 100% effective at protecting against severe disease and death, according to AstraZeneca.

The company could release c…

Dyadic and Medytox team up on vaccines targeting COVID-19 variants

The Korean biopharma Medytox and Jupiter, Fla.–based Dyadic International are partnering to develop vaccines that would protect against multiple COVID-19 variants.

The companies plan on using Dyadic’s C1-cell protein production platform in the development of the vaccines.

The vaccines would use a similar strategy to flu vaccines, which are often trivalent or quadrivalent. The former is designed to afford protection against three virus types, while the latter targets four viruses.

Medytox has explored other gene expression platforms and has concluded that the fungi-derived C1 expression system is “the most realistic technology to develop and manufacture multi-valent (i.e., tri-valent, and tetra-valent) vaccines, rapidly and affordably, against COVID-19 mutant viruses without the need for a large-scale bioreactor facility,” said Gi-Hyeok Yang, head of R&D at Medytox, in a press release.

Early Pfizer COVID-19 vaccine doses may have had potency problems

Some of the first commercially available doses of COVID-19 Pfizer-BioNTech vaccine doses had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ.

The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020.

The cybercriminals behind the attacks sent 40 MB of data to several journalists while also publishing them on the dark web.

The EMA has launched a criminal investigation related to the breach.

BMJ editors have reviewed the documents, which indicate that EMA officials were concerned about the low amounts of intact mRNA in early commercial batches of vaccines. According to one email, the impact of the loss is mRNA integrity has “yet to be defined,” according to one email.

An email from November 23 detailed concerns from a senior EMA official who worried that the early vaccine doses did…