COVID-19 vaccine

The pandemic continued to remake the pharma and biotech industry this past year. A handful of companies fared exceptionally well at commercializing COVID-19 therapies. This fact promises to lead to sizable shifts in the rankings of pharma leaders. These trends were not yet evident in our spring roundup of the 50 largest pharma companies, which…

The Walter Reed Army Institute of Research (WRAIR) is planning to announce positive early clinical results related to a novel nanoparticle-based COVID-19 vaccine, according to media reports. A Phase 1 study involving the vaccine found that it was effective against omicron, other SARS-CoV-2 variants and other coronaviruses, including SARS-CoV-1. That study began in April. A…

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels. The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days…

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided advice about using Pfizer’s COVID-19 antiviral Paxlovid. CHMP has concluded that Paxlovid (nirmatrelvir/ritonavir) could be used for adults with COVID-19 who don’t need supplemental oxygen and face an elevated risk of developing severe disease. CHMP also stressed the…

Pfizer (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) have announced that their vaccine remains effective against the Omicron variant (B.1.1.529 lineage) of SARS-CoV-2 in early lab studies. Two doses of the vaccine significantly reduced neutralization titers, while three neutralized the variant. The lab studies showed that three doses of the BNT162b2 vaccine were similar in efficacy against Omicron as two…

Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests,…

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I…

Pfizer (NYSE:PFE) accused a former employee Chun Xiao (Sherry) Li of uploading 12,000 documents from a company-issued laptop to a personal Google Drive account and various personal devices. In a complaint filed in the U.S. District Court for the Southern District of California, Pfizer also accuses Li of misleading the company about what she did with…

Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine. NIAID had awarded $36.3 million to academic institutions to working on coronavirus vaccines that potentially protect against multiple types of coronaviruses. Coronavirus…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose. The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In…

The Advisory Committee on Immunization Practices (ACIP) at the CDC voted unanimously to allow all fully vaccinated adults to receive a COVID-19 booster at least six months after receiving a primary series. All 11 members of the panel also voted on Nov. 19 to recommend boosters for adults 50 and older. Last week, FDA authorized…

FDA has authorized booster shots of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines for everyone 18 and older. Assuming CDC backs the decision, tens of millions of American adults who received two doses of the two mRNA COVID-19 vaccines at least six months ago will be eligible for boosters. “Authorizing the use of a single…

The FDA reportedly is planning to authorize the ​​Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine booster for all adults in the coming days. FDA could make an announcement on the subject as soon as tomorrow, according to The New York Times. CDC’s Advisory Committee on Immunization Practices (ACIP) plans on discussing the Pfizer-BioNTech booster data on November 19.…

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…

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 (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…