Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. bought 50 million more doses of its COVID-19 vaccine. The U.S. purchased the additional doses of the vaccine in its effort to support preparedness for pediatric vaccinations as it seeks authorization for use in younger adolescents and children. Earlier this month, Pfizer submitted a request…
Merck projects at least $5B in 2022 sales for molnupiravir
Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected. Sales of the drug could be higher, assuming it finds widespread use in wealthy countries. Merck expects sales between $500 million and $1 billion…
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…
CDC panel unanimously backs J&J and Moderna vaccine boosters
CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the Janssen (NYSE:JNJ) COVID-19 vaccine booster at least two months after the initial dose. The committee also recommended a booster of the Moderna’s (NSDQ:MRNA) COVID-19 vaccine for people 65 and a handful of other demographics. Also eligible for boosters are individuals at least 18 who are…
Why COVID-19 booster criteria will remain complicated for now
The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated. Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility. The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or…
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…
FDA authorizes heterologous vaccination
FDA will soon permit so-called “mix-and-match” COVID-19 boosters as it authorized boosters from Moderna (NSDQ:MRNA) and Janssen (NYSE:JNJ) today. The move will give healthcare workers more leeway in administering boosters. During last week’s Vaccines and Related Biological Products Advisory Committee (VRPAC) meeting, preliminary results from a federally-funded study suggested that heterologous boosters were non-inferior to…
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…
Bayer abandons plans to produce first-generation CureVac vaccine
Bayer (ETR:BAYN) had planned to retool a facility in Wuppertal, Germany, to produce CureVac’s (NSDQ:CVAC) COVID-19 vaccine. But Leverkusen, Germany–headquartered Bayer has put those plans on ice, according to the German paper Leverkusener Anzeiger. Bayer had planned on producing 160 million doses of the vaccine annually. In June, CureVac reported that its COVID-19 vaccine was 48% efficacious…
FDA advisory panel unanimously backs Moderna boosters
All 19 members of the Vaccines and Related Biological Products Advisory Committee voted to expand emergency use authorization of the Moderna COVID-19 vaccine to include boosters. The recommendation, however, limited its use to three main groups, including those 65 and older and individuals 18 to 64 with an elevated risk of developing severe COVID-19. In…
COVID drugs come in 3 flavors; it’s time for more diversity
Our industry’s response to COVID-19 defied the conventional wisdom that it takes years to deliver new drugs. Makers of monoclonal antibodies led the pack, most notably Regeneron (NSDQ:REGN), which manufactured the 8-g, two-antibody cocktail administered to then-President Donald Trump last fall. Eli Lilly (NYSE:LLY) and Vir Biotechnology (NSDQ:VIR) pulled off similar feats. Prior speed records…
Russia’s Sputnik-V vaccine has not yet received EU and WHO backing
The World Health Organization spokesperson Fadéla Chaib acknowledged undisclosed issues had delayed its emergency use authorization of Russia’s Sputnik V COVID-19 vaccine. Chaib added that the WHO was working through the issues while Russian Health Minister Mikhail Murashko recently said Russian officials were completing the final paperwork needed for the filing. Meanwhile, European Union officials…
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,…
Sweden and Denmark pause Moderna COVID-19 vaccine for younger age groups
Sweden and Denmark announced they would recommend younger individuals avoid obtaining Moderna’s (NSDQ:MRNA) vaccine until further notice. The two countries cited the potential risk of myocarditis and pericarditis. Sweden recommended halting the use of the vaccine in individuals born in 1991 or later. Meanwhile, the Danish Health Agency advised that the vaccine should not be…
Antivirals could be a vital weapon in the COVID-19 pandemic endgame
Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could…
Johnson & Johnson asks FDA to authorize COVID-19 booster
Johnson & Johnson’s Janssen division (NYSE:JNJ) has requested that FDA expand the emergency use authorization (EUA) for its Ad26.COV2.S COVID-19 vaccine to include boosters for people 18 and older. The previous EUA covered a single dose of the vaccine. On October 14 and 15, FDA will convene meetings of its Vaccines and Related Biological Products…
Early safety concerns accompanied Merck’s molnupiravir, the first potential oral COVID-19 therapy
The antiviral molnupiravir appears to be destined to become the first oral treatment for COVID-19. Merck and its partner Ridgeback Biotherapeutics intend to file for emergency use authorization after announcing that the drug appears to reduce the risk of hospitalization or death by about 50%. One potential hurdle for the drug is whether unvaccinated individuals…
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.…
FDA could support 50-µg booster dose of Moderna vaccine
The FDA could authorize the use of Moderna (NSDQ:MRNA) COVID-19 vaccine boosters at a half-dose level, according to a report from Bloomberg. Each primary series dose of the Moderna vaccine contains 100 µg of mRNA. By contrast, the Pfizer-BioNTech vaccine uses a 30-µg dose level for the primary series and boosters. Earlier this month, Moderna CEO…
CDC analysis finds COVID-19 boosters generally elicit mild-to-moderate side effects
Most third doses of mRNA COVID-19 vaccines elicit side effects in line with that of the second dose, according to a CDC report. The study analyzed immunocompromised recipients of the Pfizer-BioNTech and Moderna COVID-19 vaccine recipients eligible for a third dose. It pulled data from 22,191 V-safe registrations. V-safe is a CDC-created smartphone-based system for tracking…
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…
Pfizer launches Phase 2/3 trial of COVID-19 oral antiviral cocktail
Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis against COVID-19. The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19…
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…