Averting wildlife-borne infectious disease epidemics requires a ...
Moderna CEO Defends $130 COVID Vax Price After Bernie Sanders Jab
Moderna's chief executive on Wednesday defended the company's plan to quadruple the price of its COVID-19 vaccine, telling US lawmakers it will no longer have the economies of scale from government procurement when the shots move into the private market.
Moderna CEO Stephane Bancel was called to testify after the company flagged plans to raise the vaccine's price to as much as $130 per dose drew the ire of Democratic Senator Bernie Sanders, who chairs the influential Committee on Health, Education, Labor and Pensions and has long demanded lower drug prices.
Sanders on Wednesday asked Bancel to reconsider the price hikes, saying they could make it unaffordable for millions of Americans and were unjustified given the government's research contributions and $1.7 billion in assistance in developing the vaccine. His comments echoed his January letter to Bancel.
Bancel said Moderna's next COVID-19 shots will be more expensive because they will be sold in single-dose vials or pre-filled syringes for the commercial market versus the 10-dose vials it has sold to the government up until now.
The government in May plans to end the COVID public health emergency, putting much of the vaccine purchasing in the hands of the private sector.
Moderna CEO Stephane Bancel testifying on Wednesday.AFP via Getty Images Bancel also said the company anticipated that it would likely make more doses than needed to ensure it had enough for the private market and had calculated wasted shots into the price.
"On top of all this, we're expecting a 90% reduction in demand," Bancel said. "As you can see, we're losing economies of scale."
Sen. Bernie Sanders has long demanded lower drug prices.Getty Images Moderna in February forecast $5 billion in COVID vaccine sales this year, far less than the $18.4 billion windfall in 2022, due to decreasing demand for the shots.
Sanders has for years railed against high U.S. Drug prices and backed Medicare-for-all. His chairmanship of the HELP committee has further put drug companies in his crosshairs.
China Approves An MRNA Covid Vaccine, Its First
China has for the first time approved a Covid-19 vaccine based on mRNA technology, greenlighting a homegrown shot months after the ruling Communist Party eliminated its strict pandemic restrictions.
China has long refused to use the foreign-made mRNA shots that were crucial in easing the pandemic in many parts of the world and that the United States first authorized for emergency use in December 2020. Beijing chose instead to promote its own pharmaceutical firms, first in rolling out a more traditional but less effective Covid vaccine, and later, in the pursuit of a homegrown mRNA, or messenger RNA, vaccine.
China's new mRNA vaccine, developed by CSPC Pharmaceutical Group Ltd., based in the northern Chinese city of Shijiazhuang, was approved for emergency use by China's health regulator, according to a statement from the company on Wednesday.
Among the vaccines currently available in China, the most widely known are made by the companies Sinopharm and Sinovac. Like other traditional vaccines, they rely on a century-old method for inoculation, which use an inactivated virus to trigger a response by the immune system, and have since proven to be less effective in protecting against symptomatic disease.
The mRNA vaccines use a genetic molecule that assists cells to make proteins that can set off an immune response in the body. While new variants of Covid-19 are increasingly evasive to both traditional and new vaccines, the mRNA technology allows scientists to quickly modify shots to target the new strains.
The new Chinese vaccine comes at a time when the party and its leader, Xi Jinping, are trying to jump-start an economy that had been hurt by some of the harshest Covid-19 restrictions in the world. This month, China reopened its borders to foreign travelers for the first time since 2020, at the start of the pandemic.
For much of the pandemic, Chinese residents lived under the country's "zero Covid" policy, when unpredictable lockdowns left tens of millions of residents unable to leave their homes for weeks at a time. In major cities, P.C.R. Testing was required every one to three days to enter any public space.
The government's efforts to eradicate Covid were effective at keeping infections at bay, but they led to factory disruptions, job losses and a plunge in consumer spending. The strict restrictions triggered nationwide protests last November, the biggest challenge to Mr. Xi's authority since he became president in 2013.
China's handling of the pandemic has come under broader scrutiny as well, with the country facing renewed criticism over its efforts to thwart investigations into the origins of the pandemic. Last week, the World Health Organization accused Chinese officials of withholding research that may link the virus's origin to wild animals, asking why the data had not been made available three years ago and why it has now disappeared.
With little warning, officials ended the "zero Covid" policy in early December, removing mass testing booths and pandemic protocols virtually overnight.
A Covid outbreak quickly swept the country and overwhelmed ill-prepared hospitals, with deadly consequences. The official death toll in China for the entire pandemic is around 83,000 people. Epidemiologists widely believe the number to be a severe undercount, estimating the true toll to be 1 million to 1.5 million people.
At the height of the Covid wave, some mainland residents ventured across the border to the Chinese territory of Macau to find foreign-made mRNA vaccines. During this time, China also began to widely distribute Pfizer's Paxlovid, an oral treatment found to significantly cut the risk of hospitalization and death.
As Covid infections recede, many Chinese residents have said they are eager to travel and resume their prepandemic routines. Domestic tourism is booming, and subways in major cities are crowded with commuters.
As of mid-March, the positivity rate among P.C.R. Tests in China was below 1 percent, down from a peak of 29.2 percent in late December, according to Chinese government data. The figures have become increasingly unreliable, as officials have stopped regular mass testing and made reporting of home testing voluntary.
Developing its own mRNA shot is a source of national pride and a boon for the Communist Party leadership. Creating an mRNA vaccine from scratch is no small feat, experts have said. The first mRNA shots developed for the virus were built on decades of research by scientists around the world.
Early in the pandemic, China shipped its vaccines to poorer countries around the world, hoping to use them as a way to build allies and repair damaged diplomatic ties. The campaign, however, lost momentum when officials in several countries raised doubts about the efficacy of Chinese vaccines against more transmissible variants.
CSPC Pharmaceutical did not say when the vaccine would be available to the public. Representatives for the company did not immediately respond to requests for comment.
Until last summer, China seemed to be on track to approve BioNTech, a German mRNA vaccine made in partnership with Pfizer. Then it suddenly changed direction, all but abandoning the approval process for BioNTech.
The delay in recognizing a foreign mRNA vaccine appeared to be part of a deeply political exercise as the country has turned more inward under Mr. Xi, who has encouraged Chinese companies to be self-reliant.
As the pandemic continued, China also struggled to vaccinate its population, particularly its oldest residents.
At a news conference in November just before the country's Covid restrictions eased, Chinese health authorities said that among people who were 80 and older, about 66 percent were fully vaccinated; only 40 percent had a booster.
As the government pulled back from the "zero Covid" policy, more residents appeared to get vaccinated. Nationwide, about 91 percent have had their first two shots, according to the most recent data.
Zixu Wang contributed research.
Vaccine Makers Prep Bird Flu Shot For Humans 'just In Case' As Rich Nations Lock In Supplies
Government workers wear protective gear to collect poultry for slaughter during an outbreak of avian influenza on the Ivory Coast. More than 70 countries have reported cases this year, according to the World Organization for Animal Health. (Legnan Koula/EPA-EFE)
Some of the world's leading makers of flu vaccines say they could make hundreds of millions of bird flu shots for humans within months if a new strain of avian influenza ever jumps across the species divide.
One current outbreak of avian flu known as H5N1, clade 2.3.4.4b, has killed record numbers of birds and infected mammals. Human cases, however, remain very rare, and global health officials have said the risk of transmission between humans is still low.
Executives at three vaccine manufacturers — GSK Plc Moderna Inc and CSL Seqirus, owned by CSL Ltd — told Reuters they are already developing or about to test sample human vaccines that better match the circulating subtype, as a precautionary measure against a future pandemic.
Others, like Sanofi, said they "stand ready" to begin production if needed, with existing H5N1 vaccine strains in stock.
Dr. Shayan Sharif, a professor at the University of Guelph, with a research focus on the chicken immune system, told CBC News there's currently no vaccine licensed for use against avian influenza for either animals or humans here in Canada, but that it's time to "think very carefully" about how a vaccination campaign would be implemented in this country.
"Hopefully we would never need to have vaccination for humans," he added, "but I think we have to be ready."
There has also been a push among companies to develop a bird flu vaccine for poultry, a market potentially far larger than that for humans.
Doses earmarked for wealthy countriesMost of the potential human doses are earmarked for wealthy countries in long-standing preparedness contracts, global health experts and the companies said.
Many countries' pandemic plans say flu shots should go first to the most vulnerable while supply is limited. But during COVID-19, many vaccine-rich countries inoculated large proportions of their populations before considering sharing doses.
"We could potentially have a much worse problem with vaccine hoarding and vaccine nationalism in a flu outbreak than we saw with COVID," said Dr. Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations (CEPI), which helps fund vaccine research.
WATCHExperts believe avian flu to blame for Seabirds dying off coast of Newfoundland:
Seabirds dying of suspected avian flu off Newfoundland 8 months agoDuration 0:38
Hundreds of dead seabirds are washing ashore in parts of Newfoundland and it's expected thousands more are dead in the ocean. Tests haven't confirmed bird flu is to blame yet, but experts believe it's responsible.An international framework for pandemic flu allocates 10 per cent of global supply for the World Health Organization (WHO) to share with low- and middle-income countries. By contrast, the WHO is seeking guarantees of 20 per cent of the global supply for other types of pandemic in the wake of COVID.
The UN agency said it has signed legally binding agreements with 14 manufacturers for 10 per cent of their pandemic flu vaccine "as it comes off the production line," in a mix of donated doses and doses to be bought by the agency at an affordable price. The agreements include six of the largest seasonal flu manufacturers, such as GSK, Sanofi and CSL Seqirus, the WHO said.
WHO did not comment on the potential for vaccine hoarding in a flu pandemic but said mechanisms were being developed so that countries can work together, not in competition with each other, to respond to such a crisis. It said it was "fully confident" manufacturers and member states would meet their obligations.
New approachesIn a pandemic, vaccine manufacturers would shift production of seasonal flu vaccines and instead make shots tailored to the new outbreak when needed. They already have the capacity to make hundreds of millions of doses.
Many of the potential pandemic shots are pre-approved by regulators, based on data from human trials showing the vaccines are safe and prompt an immune response, a process already used with seasonal flu vaccines. This means they might not require further human trials, even if they have to be tweaked to better match whichever strain does jump to humans. Data on how well the vaccines actually protect against infection would be gathered in real-time.
In all, the WHO said there are close to 20 licensed vaccines against the broader H5 strain of flu. Existing antiviral treatments for people already infected will also help mitigate the impact.
At the same time, moving to large-scale production of a more targeted shot could take months, the manufacturers said. Some potential shots use a traditional method, growing the virus used in the vaccines in chicken eggs over four to six months.
"Creating the first dose is the easiest," said Raja Rajaram, head of global medical strategy at CSL Seqirus. "The hardest is manufacturing in large quantities."
Experts have long advocated for new approaches in developing vaccines, both for seasonal and pandemic flu. COVID proved the potential of mRNA technology to adapt more quickly to changing viruses because the vaccines use genetic information from the pathogen, rather than having to grow the virus itself.
Moderna's mRNA vaccine research actually began with pandemic flu, and was modified for COVID, said Raffael Nachbagauer, executive director of infectious diseases at Moderna.
Second Opinion
How deadly bird flu sparked explosive outbreaks in 2022 — and why it matters for global healthThe company plans to launch a small human trial of an mRNA pandemic flu vaccine tailored to the new avian influenza subtype in the first half of 2023, he said, adding Moderna could respond "very quickly" in an outbreak scenario. The results will be closely watched, as the data on Moderna's seasonal flu candidate was mixed.
Nachbagauer said the company was mindful of the equity issue needing to be addressed but has no contracts yet.
"It would be premature to sign anything or commit to anything that we can't actually deliver on as of today," he said.
Comments
Post a Comment