EU Commission Approves Novavax COVID-19 Boosters
The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, Japan, New Zealand, and Japan.
Moderna Looking At $100 COVID-19 Vaccines
With the US federal government ending free COVID-19 vaccines by the end of 2022, Moderna has begun deliberating the cost it will charge for the shots on the commercial market. Arpa Garay, COO of Moderna, spoke with investors Tuesday, September 8th, informing them of the company’s move towards value-based pricing. The proposed $100 price tag would be triple that paid by the US government during the ongoing pandemic.
India Approves Nasal COVID-19 Vaccine by Bharat Biotech
The Drugs Controller General of India (DCGI) has approved Bharat Biotech’s nasal COVID-19 vaccine for adults 18 and over. This is the first of its kind in the nation and is one of few nasal COVID-19 vaccines approved worldwide. Based on a modified chimpanzee cold virus, the vaccine delivers SARS-CoV-2 spike proteins directly to the nose, one of the first spots in the virus’s route of infection.
UK Begins Pfizer/BioNTech’s Bivalent Omicron COVID-19 Vaccine Booster Shot Program
The UK’s NHS has begun the rollout of Pfizer/BioNTech’s bivalent COVID-19 boosters. The launch comes after the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the shot for those 12 and older last week. The vaccine contains spike protein mRNA from both the original SARS-CoV-2 virus and the BA.1 Omicron strain.
Pfizer and BioNTech’s Bivalent COVID-19 Vaccine Boosters Get EU Approval
The European Medicines Agency (EMA) has just issued conditional marketing authorization (CMA) for both Pfizer and BioNTech’s bivalent COVID-19 vaccines. The agency’s Committee for Medicinal Products for Human Use (CHMP) approved the vaccines as boosters for people 12 and up. These vaccines contain spike protein mRNA for the original SARS-CoV-2 virus and the BA.4/BA.5 Omicron strains currently dominant across the globe.
FDA Approves Bivalent COVID-19 Vaccines from Moderna and Pfizer/BioNTech
The US Food and Drug Administration (FDA) has approved both bivalent COVID-19 vaccine boosters from Moderna and Pfizer/BioNTech. The boosters contain spike pro mRNA from the original SARS-CoV-2 virus and the BA.4/BA.5 omicron strains currently dominant worldwide. The approval comes as the agency waits for more human data to come in.
Authorization for Bivalent Omicron Boosters
Insider sources say that the US Food and Drug Administration could authorize the new bivalent COVID-19 vaccines from Moderna and Pfizer/BioNTech as early as Labor Day, September 5th. The vaccines contain mRNA for spike protein from the BA.4/BA.5 SARS-CoV-2 that currently dominating worldwide and the spike protein from the original strain from 2019 and early 2020.
FDA Commissioner Rob Califf Emphasizes Need to Combat Misinformation
Rob Califf, the commissioner of the US Food and Drug Administration (FDA), spoke about his current goals for the agency. Califf emphasized the need to continue focusing on the ongoing COVID-19 pandemic and the opioid epidemic. The nation is behind its peers in terms of vaccinations, and Americans are growing increasingly tired of COVID-19 restrictions.
Pfizer, BioNTech Apply for FDA Emergency Use Authorization for Omicron Booster
The makers of the Comirnaty COVID-19 vaccine have applied to the US Food and Drug Administration (FDA) for an emergency use authorization for their new Omicron BA.4 and BA.5 booster shots. The new version of Pfizer and BioNTech’s vaccine is bivalent, containing spike protein mRNA from the original SARS-CoV-2 and Omicron BA.4/BA.5.
US Government Announces Plans for Domestic Monkeypox Vaccine Production
In an announcement last week, the US Department of Health and Human Services (DHS) revealed a new deal between Bavarian Nordic and Grand River Aseptic Manufacturing (GRAM). The agreement will allow GRAM to manufacture Bavarian Nordic’s Jynneos monkeypox vaccine stateside. GRAM will produce 2.5 million vials from bulk vaccine, hopefully ramping up access for at-risk populations.
Biden Administration Looks to Stop Coverage of COVID-19 Vaccines and Treatments
As the US government increasingly relaxes COVID-19 guidances, the Biden administration is planning for the end of coverage for COVID vaccines and treatments. A planning session will be held by the Department of Health and Human Services on August 30th to discuss the matter with pharma representatives and officials from state health departments.
US Government Eyes Transdermal Vaccinations for Monkeypox
As cases of monkeypox rise in the US, unnamed sources are indicating the government will push for transdermal injection for Jyneos, the monkeypox vaccine produced by Bavarian Nordic. The scale of the outbreak, which resulted in a declaration of a national health emergency just last week, combined with the small supply of the vaccine has officials looking into resource-saving measures. The procedure requires just one-fifth the dose of the standard subcutaneous injection route, but requires specialized training to perform.
Moderna Makes Deal with US Govt for Augmented COVID-19 Booster
Moderna has signed a contract worth up to $1.74 billion with the US government to provide an updated version of its mRNA vaccine. This version of the vaccine targets the BA.4/BA.5 Omicron strains that are currently dominant. The deal would get the US an initial 66 million doses, which could later include an additional 234 million.
Twelve European Countries Getting Influenza Pandemic Prep from GSK
GSK has signed an agreement with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) to help prepare 12 European countries for future influenza pandemics. The agreement is another win for the pharma giant, which signed similar deals with the US, Canada, and the World Health Organization. The total amount of pandemic influenza vaccines promised in the deals reaches 200 million.
Bavarian Nordic Makes Deal to Provide 1.5M Monkeypox Vaccine Doses to Unnamed European Country
The Danish drugmaker Bavarian Nordic has signed a deal with another unnamed European nation, this time promising 1.5 million doses of its monkeypox vaccine. This is the second deal with undisclosed European countries and comes hot off the heels of a deal with the US govt for 2.5 million.
COVID-19 Pandemic Causes Largest Drop in Childhood Vaccinations in 30 Years
A report published by the World Health Organization (WHO) and UNICEF shows that 25 million children missed key childhood vaccines due to the COVID-19 pandemic. Coverage with the DTP3 vaccine, which protects against tetanus, pertussis and diphtheria, fell to 81% from 86% in 2019.
Novavax COVID-19 Vaccine Gets Emergency Use Authorization from FDA
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The announcement comes as the disease pops up across the country.
780,000 Doses of Bavarian Nordic Monkeypox Vaccine to be Shipped to US by End of July
The US Department of Health and Human Services (HHS) has announced that 780,000 doses of Bavarian Nordic’s should be headed to the US by the end of the month. The vaccines, at Bavarian Nordic’s Denmark facilities, are currently undergoing an FDA inspection and authorization. The announcement comes as the disease pops up across the country.
US Govt Signs COVID-19 Vaccine Deal With Pfizer and BioNTech Totalling $3.2 Billion
The US government has signed an agreement to purchase 105 million COVID-19 vaccine doses from Pfizer and BioNTech. The deal [...]
Bavarian Nordic’s RSV Vaccine Candidate Granted PRIME Eligibility
The PRIME scheme helps accelerate assessment by the European Medicines Agency for therapeutics that treat otherwise unmet medical needs. Bavarian [...]
Webinar – June 29th: Unraveling the Complexities in Nasal Vaccine Development, Manufacturing and Device Selection
Intranasal vaccines represent a novel delivery system that gives drugmakers, providers, and patients additional options to choose from when making [...]
Promising Results Announced for Omicron-Adapted Pfizer and BioNTech COVID-19 Vaccines
Pfizer and BioNTech have announced positive results in the Phase 2/3 trial for two Omicron-adapted versions of their mRNA vaccine. [...]
BioNTech Starts Construction of Africa’s First mRNA Vaccine Manufacturing Plant
With the construction starting for BioNTech’s new plant in Kigali, Rwanda, Africa is finally getting its first mRNA vaccine manufacturing [...]
Pharma Facing Pressure to Renegotiate COVID-19 Vaccine Contracts with EU Govts
As the demand for COVID-19 vaccines dwindle in Europe, many EU nations’ governments look to renegotiate their vaccine deals [...]
Breaking: US FDA Approves Moderna and Pfizer’s COVID-19 Vaccines for Children 5 and Under
The US Food and Drug Administration’s (FDA) vaccine advisory committee (Adcomm) voted unanimously (21-0) to approve Moderna and Pfizer’s mRNA-based [...]
