UN Negotiating Price of Takeda’s New Dengue Vaccine
The World Health Organization’s (WHO’s) Pan American Health Organization (PAHO) is working with Takeda to negotiate pricing for the manufacturer’s new dengue vaccine Qdenga, the only one for the widespread illness. A key strategy being proposed is that large nations can pool their resources to purchase the vaccines in bulk at a lower price.
FDA Plans to Authorize Additional Omicron Booster for Select Populations
A report by the Washington Post indicates that the US Food and Drug Administration is set to approve another round of boosters for adults 65 and up. The approval will also include adults who are immunocompromised. Boosters will be available for these patients for free 4 months after their last booster.
Takeda Reveals Pricing for Dengue Vaccine
Fresh off approval of its dengue vaccine in Brazil, Takeda has announced its pricing strategy for the shot. Prices will be determined by endemic status of the disease in a given country. Indonesia, where the virus is endemic, will see the vaccine priced at $40 per dose, while travel markets like Germany will pay $115 a shot.
Moderna Optimistic About Cancer Vaccine Getting Accelerated Approval
Moderna’s president Stephen Hoge told attendees at Cowen’s Annual Healthcare Conference that the company is optimistic about its chances to snag accelerated approval for its mRNA-based personalized cancer vaccine. Hoge pointed out that data from December may not be enough, but there is enough time to generate new data that may tip the scales.
Monkeypox Vaccines May Be Real-World Data’s Time to Shine
Real-world data (RWD) played a pivotal role in the rapid development and regulatory approval process for the current slate of COVID-19 vaccines. Similarly, the development and timely rollout of monkeypox vaccines depends on RWD. For example, RWD is helping inform the move to intradermal injection of Bavarian Nordic’s Jynneos vaccine to help stretch limited supplies.
Biden Declares Pandemic is Over – Vaccine Stocks Take a Hit
US President Joe Biden declared the pandemic ‘over’ in a “60 Minutes” interview this Sunday, September 18th. In response, many vaccine manufacturers saw a drop in share prices, including Moderna, Novavax, and BioNTech. This reflects a larger dip in the biotech market, particularly companies working with COVID-19 therapeutics.
South African Biotech Biovac Produces First Batch of COVID-19 Vaccine
Biovac, a vaccine producer located in South Africa, has produced its first batch of Pfizer and BioNTech’s mRNA vaccine. The company was added to Pfizer and BioNTech’s vaccine manufacturing network just over a year ago. The South African Health Regulatory Products Authority still needs to inspect the vaccines before they can be distributed.
UK MHRA Approves Novavax COVID-19 for Ages 12-17
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has given expanded conditional marketing authorization (CMA) to use the Novavax COVID-19 vaccine in people ages 12-17. The decision was made based on data from the PREVENT-19 phase 3 trial. Early data showed that it had an 80% clinical efficacy during the US’s delta wave.
Bavarian Nordic Boosts Production of Monkeypox Vaccine
Paul Chaplin, CEO Bavarian Nordic announced during a call with investors that the company has leaned heavily into production of bulk Jynneos, its monkeypox vaccine. The news comes shortly after the company made a deal with Grand River Aseptic Manufacturing to fill vials from bulk vaccine in the US. Bavarian Nordic is now dedicating all of its production capacity to Jynneos, sidelining its other vaccines
Icosavax Identifies Reason its COVID-19 Vaccine Failed, Looks Toward Future
Icosavax has just wrapped up an investigation into the disappointing results of its COVID-19 vaccine candidate, IVX-411, finding that instability issues were at fault. The receptor binding domain of the soccer ball-shaped “virus-like particle” degraded at the recommended storage temps of 2-8°C. The instability proved to diminish the effect of the vaccine in mice studies.
FDA Creates New Training Program for mRNA Vaccine Manufacturing Inspectors
As mRNA technology has been thrust into the mainstream with the advent of COVID-19 vaccines, the US Food and Drug [...]
Trends That Matter for COVID Vaccine Distribution
As details continue to emerge about the availability of COVID-19 vaccines and how they will be administered, the role that [...]
Biden Defers to Experts on COVID-19 Vaccine Prioritization
There will likely be a limited supply of coronavirus vaccine doses available immediately after a vaccine is authorized by the [...]
[White Paper] Health Technology Assessment During the COVID-19 Pandemic
The global COVID-19 pandemic currently permeates every aspect of daily life with long-lasting consequences for all sectors, including pharma and [...]
COVID-19 Vaccine Will Come At No Cost to Medicare Beneficiaries
Once approved, the Trump administration will cover COVID-19 vaccinations at no cost to Medicare beneficiaries. On Wednesday, CMS released an [...]
[Webinar] Patient-Focused Medicines Development During COVID-19
The COVID-19 pandemic has turned the lives of many patients upside down by adding additional layers of complexity. How exactly [...]
AstraZeneca Walks Back On its COVID-19 ‘No-Profit’ Pledge
Among the many pharma companies racing to develop a safe, effective vaccine for COVID-19, AstraZeneca stands out for its pledge [...]
How Can a Safe and Effective COVID‑19 Vaccine be Allocated?
A number of serious challenges exist for universal vaccination campaigns, yet manufacturers remain undeterred. AstraZeneca intends to distribute a COVID-19 [...]
How Should a Safe and Effective COVID‑19 Vaccine be Allocated? Health Economists Need to be Ready to Take the Baton
Recently, there have been encouraging commitments around the world to manufacture coronavirus disease 2019 (COVID-19) vaccines in anticipation of results from clinical studies.
Generics Form Essential Bridge to COVID-19 Vaccine
Dan Leonard, the newly named CEO of the Association for Accessible Medicines, believes that generic and biosimilar medicines are an [...]
2021 Sternfels Prize Contest Now Open
The $35,000 cash is awarded to the most novel, clinically relevant, and testable ideas in research that aim to reduce [...]
Regulators Need to Plan Now For Allocating COVID-19 Vaccine
Not enough attention is being paid to how exactly a COVID-19 vaccine will be rolled out. What will happen after [...]
Real World Evidence Poised to Tip the Balance in Fight Against COVID-19 Through Aetion’s Series B Platform
Tech startup Aetion has added US$19 million to their real-world evidence platform Series B, bringing their round to US$82 million. [...]
COVID-19 Vaccine Pricing: Are the Manufacturers Signaling their Intent?
The Wall Street Journal is reporting that vaccine manufacturers are signaling the price for coronavirus vaccines, with prices ranging from [...]
Dread Expressed by Public Health Experts on Hurried FDA Signoff on COVID-19 Vaccine
Eighty-nine sites are enrolling patients in the landmark Phase 3 trial for Moderna Therapeutics vaccine kicked off on Monday, July [...]
