COVID-19 vaccine trial

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine. A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.…

Officials at the Food and Drug Administration are considering potentially authorizing an additional booster of the COVID-19 vaccines from Moderna (NASDAQ:MRNA) as well as Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), according to the Wall Street Journal. At present, individuals 12 and older who are moderately or severely immunocompromised are eligible for four COVID-19 vaccine doses. Before the…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have begun a rolling submission for the BNT162b2 vaccine for children ages 6 months to 4 years. The FDA requested that Pfizer apply for emergency authorization for that age group, according to media reports. The agency is awaiting data from a third dose of the vaccine in the age group,…

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older. The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old. FDA did not accept the supplemental Biologics License…

Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union. Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union. Last week, the company announced that FDA…

Pfizer (NYSE:PFE) today announced that its oral antiviral cut the risk of hospitalization or death by 89% in an interim analysis of the Phase 2/3 EPIC-HR trial. Until recently, there were no oral treatments against the novel coronavirus. Molnupiravir, an oral antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, recently won approval in the United Kingdom…

The Comirnaty vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could soon be available for children between the ages of 5 and 11, now that CDC has backed its use. CDC Director Dr. Rochelle P. Walensky formally authorized the vaccine after the Advisory Committee on Immunization Practices (ACIP) unanimously recommended its use. “We know millions of parents are…

Moderna (NSDQ:MRNA) saw its share price fall 5% in mid-day trading today after the FDA said it would delay authorizing its mRNA-1273 vaccine in 12- to 17-year-olds. The agency said it needed additional time to investigate the risk of myocarditis in younger vaccine recipients. FDA informed Moderna that it may not complete its review before…

The FDA has moved to expand vaccine eligibility to include children at least 5 years old.  Earlier this week, the agency’s Vaccines and Related Biological Products Advisory Committee concluded that the benefits of the Pfizer-BioNTech (NYSE:PFE/NASDAQ:BNTX) for children 5 to 11 outweigh the risks. The recommendation pertained to two 10-µg doses of the vaccine, which is one-third…

Sanofi (NSE:SANOFI) and its partner GSK (NYSE:GSK) are hoping the low price of their experimental COVID-19 vaccine will stoke interest. In a call with analysts, Thomas Triomphe, head of the Sanofi Pasteur vaccines division, said that its vaccine would cost less than $10 per dose. For the sake of comparison, Pfizer-BioNTech and Moderna COVID-19 vaccines generally cost…

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…

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…

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’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…

Early data seem to suggest that mRNA vaccine boosters are more effective than additional doses of the adenovirus-vector COVID-19 vaccines from AstraZeneca and Johnson & Johnson. But scientists don’t currently have “any real clinical effectiveness data on this question,” said Dr. Janet Woodcock, acting FDA commissioner. To date, vaccine developers have heavily relied on antibody…

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…

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…

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 (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…

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…

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…

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.…

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…

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…

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…