Moderna

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months…

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old. Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency…

It doesn’t get any bigger than Amazon in the world of cloud computing. The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google. Dr. Taha Kass-Hout, the…

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.…

Moderna (Nasdaq:MRNA) announced today that it appointed Jorge Gomez as its new chief financial officer. Gomez resigned as CFO of Dentsply Sirona (Nasdaq:XRAY), effective May 6, to assume the same role at Cambridge, Massachusetts-based Moderna. He will join effective May 9. Dentsply Sirona said in a news release that it is initiating a search process…

Moderna (Nasdaq:MRNA) recently announced that an investigational version of its COVID-19 vaccine for potential use in children 6 months to 6 years met its primary endpoint in a Phase 2/3 study. Two doses of the vaccine were 43.7% effective at preventing infection during the omicron wave in children aged 6 months to 2 years old.…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine. Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older. In its submission, Moderna included data gathered…

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases. “It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships. “mRNA Access was…

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older. The two companies submitted two real-world data sets from Israel while the omicron variant was widespread. Pfizer notes that an additional dose…

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…

Moderna (NSDQ:MRNA) shares are on the rise on fourth-quarter results that came in ahead of the consensus forecast. MRNA shares were up 11.7% at $161.51 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 1.1%. The Cambridge, Massachusetts-based company posted…

The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals. The guidance for those vaccines was formerly 21 and 28 days, respectively.  CDC notes that an eight-week interval could be preferred for some individuals 12 and…

The Data and Safety Monitoring Board for Moderna’s (NASDAQ:MRNA) respiratory syncytial virus (RSV) vaccine program has backed the launch of a Phase 3 clinical study of the mRNA-1345 vaccine candidate. The study will focus on adults 60 years and older. RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults aged 65 years or…

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine. In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.  The study involved a total…

Moderna (NSDQ:MRNA) announced today that it received full FDA approval of the biologics license application for its COVID-19 vaccine. FDA’s approval for the company’s Spikevax mRNA COVID-19 vaccine covers the prevention of the virus in individuals aged 18 years or older. Moderna submitted for full FDA approval back in June 2021 and becomes the second…

Mere days after rivals Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced the launch of a study testing an omicron-based booster vaccine candidate, Moderna (NSDQ:MRNA) has announced its own trial of an omicron-specific vaccine. The vaccine booster candidate, mRNA-1273.529, will be the subject of a Phase 2 study involving approximately 600 participants divided into two cohorts. The…

Pfizer (NYSE:PFE) aims to have an omicron-specific version of its vaccine available by March. However, it still isn’t sure if the tweaked version will be necessary, said CEO Dr. Albert Bourla in an interview with CNBC’s Squawk Box. The “new version” of its COVID-19 vaccine, which it developed jointly with BioNTech (NSDQ:BNTX), should hopefully offer better…

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory. Researchers are now exploring dozens of new possibilities for the mRNA platform. Here, we summarize several areas where…

As COVID-19 case counts surge worldwide, executives at Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have voiced support for additional doses of their COVID-19 vaccines. Moderna CEO Stéphane Bancel predicted that a fourth dose would be necessary by the fall as the protection of vaccine-induced antibodies fades. In late December, Pfizer’s chief scientific officer Dr. Mikael Dolsten…

Moderna (NSDQ:MRNA) has dosed the first volunteer in the Phase 1 Eclipse study of mRNA-1189, an Epstein-Barr virus vaccine candidate. The study will take place at roughly 15 sites in the U.S. and involve approximately 272 healthy adults between the ages of 18 and 30. The study will be randomized, observer-blind, placebo-controlled and involve a range of doses.…

Soon after the omicron emerged, notable companies such as Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced efforts to develop a booster specific to the variant.   But several pharmaceutical companies are developing custom versions of COVID-19 vaccines for the variant or testing the efficacy of existing vaccines against omicron.  In October, the Moscow-based…

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…

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…

Moderna (NSDQ:MRNA) has announced positive interim data from the Phase 1 study of its quadrivalent seasonal flu vaccine candidate, mRNA-1010. Still, the results did not impress investors, as they seemed to be broadly in line with performance of Sanofi’s (NSDQ:SNY) common Fluzone HD flu vaccine. MRNA shares fell roughly 9% to $249.20 in mid-morning trading.…

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…