COVID-19 vaccine trial Archives - Page 3 of 13

Novel COVID-19 vaccine could offer broad immune responses across SARS-CoV-2 variants

The emerging biotech Gritstone Bio (NSDQ:GRTS) has dosed the first patient with its second-generation COVID-19 vaccine known as GRT-R910. The University of Manchester and Manchester University NHS Foundation Trust are jointly overseeing the U.K.-based Phase 1 study.

The GRT-R910 vaccine uses self-amplifying mRNA (SAM), which could optimize antigen expression at lower doses relative to conventional mRNA. The GRT-R910 vaccine targets antigens from the spike protein and highly conserved non-spike proteins on the SARS-CoV-2 virus.

Emeryville, California–based Gritstone believes the vaccine could offer a strong and durable immune response to various SARS-CoV-2 variants. It may also eliminate the need for repeat boosters, the company concluded.

The company believes that the technology will outperform the first generation of mRNA COVID-19 vaccines in those 60 and older.

“Our SAM COVID vaccine is designed to drive robust CD8+ T cell responses, in addition…

COVID-19 vaccines remain a cash cow for now

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

A handful of companies are making billions of dollars in revenues from COVID-19 vaccines. Especially well-positioned is Pfizer, which could earn $33.5 billion in COVID-19 vaccine sales this year, as it announced in its Q2 earnings statement. By contrast, J&J has forecasted $2.5 billion in COVID-19 vaccine sales this year, while AstraZeneca has seen sales of $1.1 billion in the first half of this year, according to Moody’s.

Analysts are divided, however, on how strong vaccine sales will be in 2022 and beyond.

A report from Moody’s predicts that vaccine sales next year will begin to wane given significant vaccine penetration rates and uncertain demand for boosters. Vaccine penetration rates in many G20 countries have already surpassed 60%. As a result, COVID-19 vaccine revenue i…

FDA advisory panel recommends boosters only for older and high-risk individuals

Doses of the COVID-19 vaccine are seen at Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando)

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While supporting boosters in older populations…

CDC study finds waning immunity in Pfizer-BioNTech vaccine recipients after four months

CDC today released comparative effectiveness data for the three COVID-19 vaccines available in the U.S. in individuals without immunocompromising conditions.

The CDC concluded that, from March 11 to August 15, the Moderna vaccine was 93% effective. The Pfizer-BioNTech and Janssen vaccines had lower effectiveness rates of 88% and 71%, respectively. The research also found that post-vaccination anti-spike IgG and anti-RBD IgG antibodies levels were “significantly lower” for Janssen vaccine recipients than those who received mRNA vaccines

Drawing data from more than 3,600 adults, the study interpreted vaccine efficacy as protection against hospitalization.

The report noted that all three COVID-19 vaccines available in the U.S. prevented hospitalization based on data from 21 hospitals.

The study also found that protection from the Pfizer-BioNTech vaccine dipped four months after vaccination to 77%. The effectiveness of the Moderna vaccine at that inte…

FDA advisory panel recommends boosters only for older and high-risk individuals

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19.

The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals 16 years of age and older. A total of 16 panelists voted ‘no’ while two others voted ‘yes.’

“With regard to the extrapolation of data from much older populations to 16- and 17-year-olds, we have no data on the safety in these populations at all that have been presented so far. And that concerns me significantly,” said Dr. Archana Chatterjee, VRBPAC member and dean of the Chicago Medical School. While suppo…

FDA grants expanded EUA to Lilly’s COVID-19 antibody cocktail

FDA has expanded the emergency use authorization for Lilly’s (NYSE:LLY) bamlanivimab and etesevimab combo to include post-exposure prophylaxis.

Earlier in the year, federal authorities had counseled against the use of the monoclonal antibody cocktail in several states given the rise of SARS-CoV-2 variants in the U.S., including Gamma (P.1) and Beta (B.1.351).

Meanwhile, demand for Regeneron’s REGEN-COV (casirivimab and imdevimab) antibody cocktail has grown, given its efficacy in fighting infection from a range of SARS-CoV-2 variants. The U.S. government recently agreed to purchase an additional 1.4 million doses of the COVID-19 antibody cocktail.

The revised EUA for bamlanivimab and etesevimab includes high-risk individuals 12 and older who are immunocompromised or have not been fully vaccinated, and have been in close proximity to someone infected with the novel coronavirus. The EUA also covers individuals with a high risk of exposure in an inst…

COVID-19 vaccine booster tensions mount between White House, CDC and FDA

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Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an uptick in adverse events, according to The Lancet art…

COVID-19 vaccine booster tensions mount between White House, CDC and FDA

Photo from Pexels

Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20.

But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary.

Two departing senior FDA vaccine officials recently co-wrote an article published in The Lancet arguing that insufficient evidence exists to justify the case for boosters. “Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,” the paper argues. In addition, while the public could ultimately benefit from boosting, administering boosters before they are required could lead to an…

FDA could soon greenlight COVID-19 vaccine boosters

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

While President Biden initially announced that COVID-19 boosters would be available by September 20, media reports suggested that the announcement caught FDA off guard.

White House chief medical advisor Dr. Anthony Fauci recently suggested in an interview with CBS’s “Face the Nation” that the U.S. government is scaling back its booster plan for the broader public, but that FDA could authorize Pfizer’s COVID-19 vaccine by September 20. The agency would authorize the Moderna vaccine afterward.

“The bottom line is very likely, at least part of the plan [to authorize mRNA boosters] will be implemented, but ultimately the entire plan will be,” Fauci said.

The U.S. will likely stick by its earlier plan to provide booster doses of mRNA vaccines eight months after administering the…

Study finds Moderna’s COVID-19 vaccine drives a stronger antibody response than Pfizer’s

Research published in JAMA found the Moderna’s COVID-19 vaccine drove an antibody response that was more than two times greater than that of Pfizer’s.

Specifically, the Moderna mRNA-1273 vaccine generated post-second-dose antibody levels of 2,881 units per milliliter. Those who received the Pfizer-BioNTech BNT162b2 vaccine had antibody levels measuring 1,108 units per milliliter.

The study involved 1,647 fully vaccinated healthcare workers in Belgium.

Immune protection, however, involves more than antibody levels. Pfizer researchers found that recipients of their vaccine have immune protection 12 days after vaccination when there are low antibody levels, according to a STAT article.

In volunteers who had previously contracted COVID-19, the Moderna vaccine recipients generated antibody levels of 3,836 units per milliliter, while antibody levels in Pfizer-BioNTech vaccine recipients were 1,444 units per milliliter.

Some 688 volunt…

Third dose of Pfizer COVID-19 vaccine boosts protection in people over 60

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

Israeli researchers report that an additional dose of Pfizer (NYSE:PFE) and BioNTech’s (NISDQ:BNTX) COVID-19 vaccine leads to notable improvements in immunity in people 60 and older.

The protection against infection increased fourfold 10 days after administration of the third dose, according to scientists at the Gertner Institute (Ramat Gan, Israel) and KI Institute (Kfar Malal, Israel). In addition, patients who received a third dose had four to six times greater protection against severe illness and hospitalization.

In people over 60, a third dose was 86% effective in protecting against infection.

The country began distributing booster doses for people over 60 on July 30. In addition, Israel has recently made booster doses available to people 30 and older who had received…

NIH to study third dose of COVID-19 vaccine in people with autoimmune disease

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination.

The Phase 2 study will also test the impact of pausing immunosuppressive medication to determine if it improves the antibody response.

The study, titled “COVID‐19 booster vaccine in autoimmune disease non‐responders,” will test an additional dose of vaccines from both Pfizer-BioNTech and Moderna.

The National Institute of Allergy and Infectious Diseases (NIAID), an NIH division, is sponsoring the study.

The study will first focus on people with one of the following autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.

On Aug. 12, FDA authorized an additional dose of Pfizer-BioNTech and Moderna COVID-19 va…