FDA’s Vaccines and Related Biological Products Advisory Committee has endorsed the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine for children 5 to 11. A total of 17 out of 18 members voted that the vaccine’s benefits outweighed the risk in the age group. VRBPAC member Dr. Michael Kurilla, the director of NIH’s Division of Clinical Innovation, abstained from…
Moderna releases positive interim Phase 2/3 COVID-19 vaccine data for children 6 to 11
Moderna (NSDQ:MRNA) said two 50-μg doses of its mRNA-1273 vaccine fared well in a planned interim analysis of the Phase 2/3 KidCOVD study involving children between the ages of 6 and 11. Last week, rival vaccine maker Pfizer (NYSE:PFE) announced that two 30-μg doses of the BNT162b2 vaccine were 90.7% against COVID-19 in a study…
Pfizer-BioNTech COVID-19 vaccine was 91% effective in 5- to 11-year-olds in Phase 3 study
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have announced that their COVID-19 vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11. The study concluded that a 10-µg dose of the BNT162b2 vaccine, which is one-third the amount authorized for people 12 and older, had the best benefit-risk profile. Recipients…
White House reveals plan to vaccinate children aged 5 to 11
The White House says that vaccine doses will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them. The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination. Pfizer (NYSE:PFE) recently asked FDA to…
Lancet study could bode well for mix-and-match COVID-19 vaccination
The mRNA vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) appear to work well as a second dose in recipients of a single dose of the AstraZeneca (LON:AZN) AZD1222 vaccine. A report in Lancet found that two doses of AstraZeneca’s AZD1222 vaccine were 50% effective. Recipients who received a dose of the AZD1222 vaccine followed by…
FDA hits pause on reviewing Moderna COVID-19 vaccine for adolescents
The FDA will postpone considering whether to extend emergency use authorization of Moderna’s (NSDQ:MRNA) COVID-19 vaccine over myocarditis concerns. Some regulators have concluded that the risk of myocarditis is higher in recipients of the Moderna vaccine than the Pfizer-BioNTech vaccine. Japan recently authorized men 30 and under who received an initial dose of the Moderna…
Pfizer officially asks FDA to expand COVID-19 vaccine access to younger kids
Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand the authorization of their COVID-19 vaccine to younger children. Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older,…
India’s Gennova developing mRNA COVID-19 vaccine
India is vying to create domestic mRNA COVID-19 vaccines, with Gennova Bio (Maharashtra) emerging as a frontrunner. The company’s investigational HGCO19 vaccine will be the focus of a Phase 2/3 study. The vaccine, developed in collaboration with privately-held Seattle-based HDT Bio, has received funding from India’s Department of Biotechnology and Ministry of Science and Technology.…
Pfizer and BioNTech submit initial data to FDA on its COVID-19 vaccine and younger children
Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11. The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA. The companies last week announced that the…
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…
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…
COVID-19 vaccines remain a cash cow for now
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…
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 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 interval was 92%. The CDC also concluded that, from March 11…
FDA advisory panel recommends boosters only for older and high-risk individuals
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, and individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to…
COVID-19 vaccine booster tensions mount between White House, CDC and FDA
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…
FDA could soon greenlight COVID-19 vaccine boosters
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…
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…
Third dose of Pfizer COVID-19 vaccine boosts protection in people over 60
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).…
Pfizer seeks FDA blessing for COVID-19 vaccine booster
Pfizer (NYSE:PFE) and its partner BioNTech SE (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate…
FDA approves Pfizer-BioNTech COVID-19 vaccine
The FDA today issued approval for Pfizer and BioNTech’s COVID-19 vaccine, making it the first to receive full approval in the U.S. The approval covers the prevention of COVID-19 in individuals 16 years of age and older. The vaccine remains available under FDA emergency use authorization (EUA) for people who are 12 years of age…
CDC advisory committee recommends additional vaccine dose for immunocompromised
The panel joined FDA in endorsing a third dose of Pfizer-BioNTech and Moderna vaccines for moderately to severely immunocompromised patients. The Advisory Committee on Immunization Practices (ACIP) concluded there was insufficient evidence to recommend an additional dose for immunocompromised recipients of Janssen’s COVID-19 vaccine. The ACIP panel described the third dose of vaccine as part…
FDA allows Pfizer-BioNTech and Moderna boosters in the immunocompromised
The FDA has authorized boosters for certain vaccinated individuals, but the agency believes there is insufficient evidence to recommend boosters to the broader population. The amended EUA applies to the Pfizer-BioNTech or Moderna vaccines. The individuals covered in the EUA include solid organ transplant recipients and people with other medical conditions leading to a moderate…
Prominent COVID-19 vaccine makers continue to make case for boosters
The case for boosters has gained ground amidst the surge in COVID-19 infections over the past month. BioNTech CEO Özlem Türeci recently recommended that health officials administer a third dose six to 12 months after the second dose to “maintain the highest level of protection.” Pfizer CEO Dr. Albert Bourla has made similar recommendations. Pfizer…
Study finds mild short-term impact from myocarditis after COVID-19 vaccination
Despite the rare risk of myocarditis in children, the benefits of the Pfizer-BioNTech BNT162b2 vaccine likely outweigh the risks, according to a recent JAMA Cardiology report. A separate pre-print study found that adolescents’ risk of contracting myocarditis is substantially higher after contracting COVID-19 than from receiving mRNA vaccines targeting the novel coronavirus. An earlier JAMA…
Novavax stock surges after striking EU COVID-19 vaccine deal
Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine. The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial…