CDC Adcomm Hesitantly Recommends RSV Vaccines for Older Adults
GSK’s Arexy and Pfizer’s Abrysvo vaccines for respiratory syncytial virus (RSV) have received recommendations from the US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP). While the committee voted almost unanimously in support of the vaccines for adults aged 60-64, the recommendation for adults over 65 was far more contentious, sitting at 9-5 for and against, respectively.
GSK’s RSV Vaccine Nabs First EU Approval of its Kind
Glaxo-Smith Klein (GSK) has received approval by the European Commission for its respiratory syncytial virus (RSV) vaccine Arexvy in adults aged 60 and up. This marks the first EU approval of a vaccine for RSV vaccine. This puts them ahead of Pfizer, whose vaccine Abrysvo has yet to be approved in the EU.
Pfizer’s RSV Vaccine Gets FDA Approval
The US Food and Drug Administration (FDA) has given approval for the use of Pfizer’s respiratory syncytial virus (RSV) vaccine in older adults. The move comes shortly after the agency approved another RSV vaccine from GSK. This sets up a marketplace standoff between the two, competing over a market that’s estimated at $17 billion.
US Runs Out of J&J’s COVID-19 Vaccine
The US Centers for Disease Control and Prevention (CDC) has announced that the US is officially out of J&J’s COVID-19 vaccine. The final batches of the vaccine expired earlier this month and now the agency is ordering all remaining vials to be disposed of. The vaccine’s administration has long been restricted to certain groups with limited access to the more widely used mRNA vaccines.
FDA Approves First Ever RSV Vaccine by GSK
For the first time ever, a vaccine for respiratory syncytial virus (RSV) has been approved by the US Food and Drug Administration (FDA). GSK’s vaccine, named Arexvy, is now approved for adults over 60 years of age based on strong data showing it reduced infections and severe cases of the disease. The move comes as an RSV candidate from Pfizer faces an imminent decision.
Biden Administration to Provide Free COVID-19 Vaccines to Uninsured People
The Biden administration is finalizing its plan to make COVID-19 vaccines, tests, and treatment free for uninsured people as the vaccines enter the commercial market. Once fully commercialize, prices for the mRNA-based shots from Moderna and Pfizer/BioNTech are set to spike to $100+. To curb this, the administration will prepare a stockpile of vaccines and therapeutics.
Merck’s MMRV Vaccine Gets FDA Approval for Intramuscular Delivery
The US Food and Drug Administration (FDA) has cleared intramuscular administration for measles, mumps, rubella, and varicella (MMRV) vaccines from Merck. This opens up more options for care providers and marks a shift from subcutaneous injections, which were the standard for the shot. The approval covers three of Merck’s MMRV vaccines.
Pfizer and BioNTech Apply for FDA Emergency Use Authorization of Omicron Booster in Children
Pfizer and BioNTech have applied for emergency use authorization from the US Food and Drug Administration for their Omicron-targeted bivalent COVID-19 vaccine in children 4 and under (to 6 months). The application specifically is for the vaccine as a second booster, or fourth dose, as it is already approved for young children as a third dose.
FDA Advisory Committee Recommends Approval of Pfizer’s RSV Vaccine
Pfizer received a recommendation from the US Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRPAC) for its respiratory syncytial virus (RSV) vaccine, dubbed RSVpreF. The recommendation is for adults over 60 years old, the group most impacted by the recent wave of RSV infections.
Moderna CEO Will Testify Before Senate Committee Headed by Sanders Over COVID Vaccine Price Hike
Stéphane Bancel, CEO of Moderna, will speak before a US Senate committee headed by Sen. Bernie Sanders (I-VT) over planned price hikes for the company’s COVID-19 vaccine. The shot, which the US federal government paid around $30 per dose for during the pandemic, will jump in price to $130 as it enters the market.
Moderna and Pfizer COVID-19 Vaccine 4X Price Increase Worries UK and US Lawmakers
As the COVID-19 pandemic inches closer to its endemic phase, Moderna and Pfizer are gearing up to nearly quadruple the price of their mRNA-based vaccines. This has drawn concern and ire from politicians in the UK and US, with four members of the UK Parliament penning a letter urging them to reconsider due to the proposed price hike’s impact on the NHS.
US Senators Blast Moderna for COVID Vaccine Price Hikes
Moderna is drawing heat from some US lawmakers and political leaders over its plans to spike prices of its COVID-19 vaccine to $110-130 per shot. The planned price hike, which is higher than the original price increases floated last fall, was lambasted by senators like Bernie Sanders (I-VT), Elizabeth Warren (D-MA), and Peter Welch (D-VT).
Moderna Eyes ~$120 COVID-19 Vaccine Price Tag
Moderna is looking to price its mRNA COVID-19 vaccine between $110 and $130 per shot, according Moderna CEO Stephane Bancel in an interview on Monday. The US government currently pays a discounted price of $26 per dose, but as the contract and the public health emergency comes to an end, most vaccine manufacturers are gearing up for price hikes.
Interview with Director of FDA’s CBER, Peter Marks
Ben Comer, Chief Editor of Life Science Leader, spoke with Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last year to discuss the Center’s goals for the coming year. The first priority is working through a backlog of vaccine-related submissions and reviewing evidence from vaccines approved via Emergency Use Authorizations (EUAs).
Real-World Data Shows Bivalent COVID-19 Boosters Reduce Hospitalizations and Urgent Care Utilization for Older Adults
Two recently published studies have found that inoculation with the new bivalent COVID-19 mRNA boosters by Moderna and Pfizer reduce the rate of hospitalization and urgent care visits. Older adults were particularly protected by the shots, which boasted an efficacy against hospitalization of 83% and 73% compared to unvaccinated older adults and those only receiving two or more doses of the original vaccines, respectively
US Senators Pillory Pfizer Over Coming Price Hikes
US Senators Elizabeth Warren (D-MA) and Peter Welch (D-VT) released a letter addressed to Pfizer’s CEO decrying the pharma giant’s plans to spike the price of its COVID-19 vaccines by $100. The jump would bring the price per vaccine up to $130, a far cry higher than the $20 price tag the federal government paid for the vaccine in 2020.
EMA and ECDC Collaborate on Vaccine Real-World Evidence Generation Efforts
Officials from the European Centre for Disease Prevention and Control (ECDC) and European Medicines Agency met earlier this month to begin a new collaboration intended to boost real-world evidence (RWE) generation for vaccine safety and efficacy trials. The collaboration, the Vaccine Monitoring Platform (VMP), will work to develop an RWE infrastructure for vaccines in the EU without outside industry funding.
EMA Emergency Task Force Recommends Bivalent COVID-19 Vaccines for Initial Inoculations
An Emergency Task Force (ETF) of the European Medicines Agency (EMA) has announced that it supports the use of bivalent mRNA COVID-19 vaccines for primary inoculations. The vaccines, which contain mRNA from the original SARS-CoV-2 and the Omicron BA.4/BA.5 strains, were previously only used as boosters for those who have already been vaccinated with one of the original versions of the shots.
Bivalent COVID-19 Boosters Bolster Efficacy of Original Versions, Real-World Data Study Finds
Newly released data from the US Centers for Disease Control and Prevention (CDC) show that patients vaccinated with the new wave of bivalent COVID-19 boosters had better protection than those that have only taken the original versions. Moreover, results from the real-world data (RWD) study show that the bivalent boosters appear to work better the longer its been since the previous administration.
Analysis Finds HPV Vaccinations for At-Risk Populations Covered By Majority of Medicaid Plans
A paper published in JAMA Dermatology late last month found that HPV vaccinations are covered for most people on Medicaid plans, including people with dermatological conditions that put them at-risk for negative health outcomes from HPV infections. The researchers looked at late-2021 data covering Medicaid plans in every US state.
Pfizer Considering 400% COVID-19 Vaccine Price Increase in US
Since their release to the general public last year, the US government has been purchasing and providing COVID-19 vaccines free of charge to patients. With this program set to end soon as public demand for the vaccine draws down, Pfizer is looking to hike its price up by 400% as it enters the commercial market.
Real-World Data Shines in Monkeypox Vaccine Efforts
Much like the COVID-19 pandemic, the global monkeypox outbreak and subsequent vaccine development and distribution efforts have highlighted the utility of real-world data (RWD). An example has been the push towards intradermal administration of Bavarian Nordic’s Jynneos monkeypox vaccine, a move done to stretch reserves in the midst of a then-pressing shortage. RWD has helped researchers investigate this application despite not having major randomized controlled trials (RCTs).
Bavarian Nordic Nets $470 Million in Updated Deal Monkeypox Vaccine Deal with Canada
The Canadian government has extended a deal with the vaccine manufacturer Bavarian Nordic for Jynneos (Imvamune in Canada), its monkeypox vaccine. The updated deal adds another $234 million in vaccine doses in the short-term and $180 million in doses doled out in batches through 2032.
Pfizer Gets Positive Data in EU Trial for 20-Valent Pneumococcal Vaccine
Pfizer has reported promising results from an EU late-stage trial supporting the use of its 20-valent pneumococcal vaccine in infants. The results will be used in Pfizer’s filing of the vaccine with the European Medicines Agency, which is expected to be completed by the end of 2022. This news comes just over a month after the company reported results from a similar trial in the US.
EU’s CHMP Recommends Evusheld by Astrazeneca for Use in Treating COVID-19
Astrazeneca has received a conditional recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its COVID-19 treatment Evusheld. The treatment contains two antibodies against the SARS-CoV-2 virus produced by donated B-cells from people who’ve had COVID-19 in the past.
