COVID-19 vaccines Archives - Page 8 of 24

CDC director recommends boosters for more Americans

CDC Director Dr. Rochelle P. Walensky issued guidelines for COVID-19 boosters, clearing the way for tens of millions of U.S. citizens to obtain a third dose of the Pfizer-BioNTech COVID-19 vaccine.

While FDA and the Advisory Committee on Immunization Practices (ACIP) reached broadly similar conclusions regarding booster doses for seniors and high-risk individuals, Walensky went further. A CDC statement also recommends boosters for people 18 to 49 with underlying medical conditions and people 18 to 64 with a high risk of occupational or institutional exposure.

Dr. Rochelle Walensky

The eligible underlying medical conditions range from having a high body mass index and a history of smoking to HIV and cancer.

Walensky said CDC would review data related to the Moderna and J&J vaccines related to their use as boosters. Both companies have released early data suggesting that boosters of their vac…

Moderna CEO predicts the pandemic will be over in a year

In an interview with the German-language Neue Zürcher Zeitung, Moderna leader Stéphane Bancel shared his predictions about the course of the pandemic.

When asked when the pandemic phase would end, Bancel replied: “As of today, I assume in one year.”

Seniors will need yearly COVID-19 boosters, Bancel said, while the rest of the public will benefit from boosters once every three years.

The durability of COVID-19 vaccines depends on age. Bancel pointed to the coronavirus OC43 as a case in point. The virus, which causes mild-to-moderate respiratory infections, tends to infect older people annually, while younger people about once every three years. “That shows us approximately the path we will tread with COVID-19,” Bancel told the newspaper.

The company is developing a flu vaccine that will cover OC43. In addition, the company is also developing a combination flu–COVID-19 vaccine.

Bancel is confident in the need for boosters, arguing that the e…

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

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…

Why the pandemic is a crucible for clinical trial innovation

Image from Sam Moqadam on Unsplash

The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations.

To get a clearer sense of what the ramifications of this accelerated development will be for the industry at large, we spoke with Neta Bendelac, senior director of strategy at 4G Clinical, which offers software and services for clinical drug trials.

Drug Discovery & Development: What impact has the pandemic had on trials for COVID-19 therapies?

Neta Bendelac: Speed was the most important factor for the early COVID-19 studies as many sponsors raced to get promising therapies and potential vaccines into the clinic. We all felt the urgency, all day, every day. It made sense for the FDA to sti…

President Biden announces COVID-19 vaccine mandates

President Joe Biden poses for his official portrait Wednesday, March 3, 2021, in the Library of the White House. (Official White House Photo by Adam Schultz)

In the early days of the administration, the White House stressed the importance of providing adequate infrastructure for mass vaccination. But now that vaccination rates have stalled, President Biden is advocating a more forceful approach.

In an address yesterday, Biden advocated that the private sector enact vaccine mandates and urged healthcare workers to recommend shots for the unvaccinated.

The Labor Department will require private-sector businesses with more than 100 employees to enact vaccine mandates or face weekly testing.

The U.S. government has also required vaccination for members of the armed forces, federal contractors and the majority of federal employees.

CMS will also require vaccination of healthcare workers wh…

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…