Moderna

Moderna’s mRESVIA (mRNA-1345) has become the first mRNA-based vaccine for respiratory syncytial virus (RSV) to receive FDA approval. The vaccine is indicated for the prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. This milestone marks Moderna’s second FDA-approved product after its COVID-19 vaccine. Earlier this year,…

GSK (NYSE:GSK) is aiming to expand the label for its respiratory syncytial virus (RSV) vaccine Arexvy, which was the first to win FDA approval. The firm is now eyeing an extension of the label to include adults aged 50 to 59, bolstered by encouraging preliminary data from a phase 3 study. The recent data from…

As Pfizer and Moderna receive the FDA nod for COVID-19 boosters, their 2023 global sales projections appear to be just a fraction of the previous year’s. In 2022, Pfizer and its partner BioNTech jointly sold $56 billion worth of their Comirnaty COVID-19 vaccine, marking the best-selling drug of the year. Moderna’s Spikevax COVID-19 vaccine wasn’t…

With updated COVID-19 boosters set to launch in the near future and COVID-related hospitalizations on the rise again, scrutiny is on the rise of emerging variants and the benefit-safety profile of COVID-19 vaccines. We performed a retrospective analysis of data from the Vaccine Adverse Event Reporting System (VAERS), focusing on the period covering the launch…

[Updated September 7. Article originally posted on July 21, 2023. Updates follow in bold:] The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is backing a significant shift in the current COVID-19 vaccine strategy: a move from multivalent to monovalent vaccines focusing on the XBB lineage strains. More recently, the emergence of new variants such…

Against the backdrop of a nearly 16% spike in COVID-19 hospitalizations in late August, according to CDC data, federal authorities are gearing up to greenlight updated boosters. Moderna announced that its latest COVID vaccine is effective against this new strain. Meanwhile, Pfizer revealed positive preclinical data for its vaccine, developed in collaboration with BioNTech. In…

COVID-19 vaccine giants Pfizer and Moderna are gearing up for a battle against the Eris SARS-CoV-2 subvariant, which has rapidly emerged as the dominant strain in the U.S. Eris now is responsible for more than one in five COVID infections, based on CDC estimates from August 6 to 19. Pfizer has noted that its most…

Moderna surged to prominence thanks to its rapid development of a competitive COVID-19 vaccine. Since the early days of the pandemic, however, the company has struggled to maintain its momentum. Year-to-date, its stock is down close to 40%, trading around $110 per share. Adapting to COVID-19 variants The company hopes that its development of vaccines…

The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19…

mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer/BioNTech generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But demand for COVID-19 vaccines continues to cool. In 2023, Comirnaty brought in $15 billion between its two…

mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434). The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a…

The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old. FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.…

FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX). The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old. Individuals in those age groups who have waited…

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer (NYSE:PFE) and its COVID-19 vaccine partner BioNTech (Nasdaq:BNTX) over patent infringement in U.S. and German courts. Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany. The suits could…

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.  But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.  A variety of companies are developing next-generation COVID-19 vaccines that could potentially…

The U.S. government will pay $1.74 billion to buy 66 million doses of Moderna’s COVID-19 vaccine made with the new omicron-adapted formula, the drugmaker said today. The government has the option to acquire up to 300 million total doses of the omicron boosters under the agreement. The U.S. last month agreed to buy 105 million…

The federal government continues to work closely with notable COVID-19 manufacturers, including Moderna and Pfizer, hosting a summit today focused on the future COVID-19 vaccines. “We need a vaccine that can stand up to multiple variants,” said White House Covid-19 Response Coordinator Ashish Jha. While White House officials called for developing inexpensive novel vaccines that…

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time. FDA today followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the…

GSK plc (LSE/NYSE:GSK) and Sanofi (EPA:SAN) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study. For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron. The vaccine is based on the original D614 virus and the beta (B.1.351) strain.…

European Medicines Agency (EMA) has begun a rolling review for updated versions of Moderna’s and Pfizer/BioNTech’s vaccines modified to optimize protection against newer variants of SARS-CoV-2. Earlier this month, Moderna (Nasdaq:MRNA) announced that its Omicron-containing bivalent COVID-19 booster candidate, mRNA-1273.21, provided an antibody response that was statistically superior to the original version of the vaccine,…

Until recently, the Pfizer-BioNTech COVID-19 vaccine was available for all individuals 5 years of age and older, while the Moderna vaccine was authorized for individuals at least 18. Now, the FDA has authorized the use of both vaccines in children from 6 months to four years old. In addition, the agency also agreed to allow…

An FDA panel voted 21 to 0 to authorize the Pfizer/BioNTech and Moderna COVID-19 vaccines in children between the ages of 6 months and 4 years of age. Children under the age of 5 constitute the only age group that has not been eligible to be vaccinated against COVID-19. “I know there are a lot…

In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines…

Moderna (Nasdaq:MRNA) has announced that its omicron-containing bivalent COVID-19 booster candidate mRNA-1273.214 yielded 1.75 times more neutralizing antibodies than its FDA-approved mRNA-1273 vaccine. The company also noted that a booster dose of mRNA-1273.214 increased neutralizing geometric mean titers (GMT) against the omicron variant roughly eight times over baseline levels in the primary immunogenicity study. The…

Moderna’s (NYSE:MRNA) bivalent booster COVID-19 vaccine candidate, mRNA-1273.211, bested its first-generation mRNA-1273 vaccine in a Phase 2/3 study. The study compared the neutralizing antibody levels generated from both vaccine boosters. The mRNA-1273.211 vaccine booster candidate offered superior performance against all variants of concern, including omicron. The company notes that the mRNA-1273.211 booster outperformed the first-generation…