Mexico’s foreign minister Marcelo Ebrard said on Friday that CureVac and Novavax have begun their phase III clinical trials in Mexico for a COVID-19 vaccine.
China’s CanSino Biologics Inc is due to present the results of its phase III trial, Ebrard also said.
AstraZeneca said initial deliveries to the European Union of the COVID-19 vaccine it is developing with Oxford University will fall short of the targeted volumes because of a glitch in production.
“Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” a company spokesman said in a written statement, declining to provide details.
“We will be supplying tens of millions of doses in February and March to the European Union, as we continue to ramp up production volumes,” he added. He would not provide the initial volume target.
A decision on the EU’s regulatory approval of the compound has been expected for the end of January.
Walmart Inc said it is preparing to offer COVID-19 vaccinations in seven more states, as well as in Chicago and Puerto Rico, this week and next, expanding beyond the two states where its pharmacists are offering inoculations.
The move from the world’s largest retailer comes as U.S. President Joe Biden races to accelerate a frustratingly slow vaccination campaign that has stranded about half of the 38 million shots distributed in freezers rather than in arms.
This week and next, Walmart will start providing inoculations in Georgia, Indiana, Louisiana, Maryland, New Jersey, South Carolina and Texas as well as in Chicago and Puerto Rico, a company spokeswoman told Reuters late on Thursday. The shots will only be available to specific populations decided by each state and only at a handful of stores in each state.
Walmart is already vaccinating healthcare workers in New Mexico and its home state of Arkansas.
Alabama’s health officer, Scott Harris, on Thursday said the state would partner with Walmart to provide COVID-19 vaccinations. Walmart confirmed that deal, which falls under a federal partnership that Biden on Thursday said would launch in early February.
Harris said another deal, with a major pharmacy chain, is coming soon.
Walgreens, CVS, Kroger and Rite Aid have also stepped up to vaccinate Americans in what is the largest and most complex immunization effort in U.S. history. Those shots are needed to help stop the virus, which has killed more than 400,000 and infected more than 24 million people in the United States.
The Trump administration punted vaccine planning to states, which were asked to come up with their own plans, a move that left many pharmacy chains and supermarket-based pharmacies in limbo.
“We’re having to be flexible as we try to operate state-by-state, but we feel like it’s absolutely the right thing to do, to lean into this and help figure it out,” Walmart Chief Executive Officer Doug McMillon said at the Consumer Electronics Show last week. “That’s the approach that we’re taking.”
He said Walmart is “making sure that we can handle the Pfizer vaccine, the Moderna vaccine and do so appropriately and safely.”
Walmart said in a blog post on Friday it expects to be able to deliver 10 million to 13 million doses per month at full capacity, using its network of more than 5,000 pharmacies in the United States and Puerto Rico.
The retailer also said it is positioned to serve “healthcare deserts” - rural areas lacking in healthcare facilities - and will host COVID-19 vaccination events in underserved communities at churches, stadiums and youth centers.
A spokesperson from the Texas Department of State Health Services said many of Walmart’s pharmacies have enrolled as vaccine providers in the state, but that “only a handful” have received the doses so far due to limited supply. “Once there’s a broader supply and we can regularly start allocating to more pharmacies, they will be included,” the spokesperson said.
Arkansas Governor Asa Hutchinson told Reuters it plans to “continue and expand” its existing partnership with Walmart, and that as additional vaccine doses become available, Walmart has agreed to be a key part of its distribution plan.
Intuitive Surgical (ISRG) offered a dim view for 2021 as hospitals "clamp down on surgeries" amid the raging pandemic. In response, ISRG stock toppled to a month-low on Friday.
During the fourth quarter, procedures using Intuitive Surgical's robotic surgery system, known as da Vinci, rose 6% overall, the company reported late Thursday. That slowed down from 7% growth in the third quarter, but improved from a 19% dive in the second quarter.
Still, the robotic surgery giant didn't offer a formal outlook for 2021, citing the unpredictable nature of the coronavirus pandemic — and investors hammered ISRG stock.
"Intuitive Surgical is a procedural bellwether, so how Intuitive Surgical sees procedure dynamics shaping up matters for sentiment in the sector," BTIG analyst Ryan Zimmerman said in a report to clients. He has a neutral rating on ISRG stock.
The coronavirus pandemic has impacted various geographies differently, Intuitive Surgical said. That trend is expected to continue, Zimmerman said. He expects first-quarter procedures to be in line to down sequentially.
"Procedure growth in the U.S. and Europe declined as the quarter progressed as Covid resurged," he said. "Nonetheless, bariatrics in the U.S. and new systems installed in China drove procedure growth, such that U.S. procedures landed up 5% year over year and overall procedures landed up 6% year over year."
In total, Intuitive Surgical shipped 326 da Vinci robotic surgery systems, down 3%. That topped the company's expectations. But Zimmerman noted hospitals likely had excess cash to spend at the end of the budget year.
"While hospitals fill this existing capacity and reset budgets against the backdrop of Covid continuing to straight hospital profitability, capital revenue headlines likely continue," he said.
As pre-announced, fourth-quarter sales grew 4% to $1.33 billion. Adjusted earnings were $3.58 a share, up by a dime year over year. Both measures beat the estimate from FactSet for $1.25 billion in sales and profit of $3.12 a share.
https://www.investors.com/news/technology/isrg-stock-intuitive-surgical-earnings-q4-2020/
The state-owned backers of Russia’s Sputnik V coronavirus vaccine have ruled out a US filing, as talks began in earnest with European regulators over a review.
Following a press conference on Thursday morning, the Russian Direct Investment Fund (RDIF), which has been bankrolling the vaccine developed by a team in Moscow, said it had already had enough orders for the vaccine.
RDIF, which is Russia’s sovereign wealth fund, said that with 2.4 billion doses already ordered worldwide, enough for 1.2 billion people, there is no interest in supplying a US market of 328 million people.
“Why should we?” said an RDIF spokesperson when pharmaphorum asked if there were plans to file the vaccine developed by the Gamaleya Research Institute with the FDA.
Supplies of the vaccine are due to begin shipment to Hungary, where the national regulator has independently approved it in a move that has caused tension with the rest of the EU.
The spokesperson’s comments came after CEO Kirill Dmitriev focused on the importance of keeping politics out of the vaccine approval process in today’s briefing.
A major peer-reviewed study of the vaccine is due for publication next week, Dmitriev said, who made the case for the vaccine’s safety, efficacy and easy storage and transport requirements.
Praising regulators that had approved the vaccine so far, such as Hungary and the United Arab Emirates, Dmitriev said: “A non-political approach will save the world. We believe it will be one of the most widely accepted vaccines in the world.”
He also referred to press reports from Israel raising concerns about the efficacy of the initial Pfizer vaccine shot, while claiming that Sputnik V can produce 73% efficacy after its first dose.
To get the shot approved across Europe RDIF must get Sputnik V centrally authorised by the European Medicines Agency (EMA), following guidance announced earlier in the pandemic.
There have already been preliminary “Scientific Advice” talks with the EMA ahead of a potential rolling review beginning next month, although the RDIF gave no further guidance on timelines.
The RDIF is to receive support from the German regulator to get the vaccine reviewed by the EMA, the spokesperson.
Chancellor Angela Merkel said today that Germany’s regulator the Paul Ehrlich Institute, can provide assistance in the process.
The first shot to win the backing of a national regulator last summer, Sputnik V only needs to be stored at conventional refrigerator temperatures instead of the ultra-cool temperatures required to maintain the integrity of delicate mNRA vaccines from Pfizer/BioNTech and Moderna.
Study data so far suggest that at 90% effectiveness it provides protection that is almost on par with the mRNA vaccines, while AstraZeneca’s rival is only 62% effective in its approved formulation.
RDIF was established in 2011 by the Russian government to make investments in leading companies and high-growth sectors of the country’s economy, looking for co-investment from large institutional investors.
https://pharmaphorum.com/news/russia-rules-out-us-filing-for-sputnik-v-covid-19-shot/
As the number of patients vaccinated across the US nears 20MM, a growing number of states are warning about a disturbing trend that, as it happens, dovetails with the WHO's warnings about inequality related to vaccine access: More wealthy patients are engaging in "vaccine tourism" - shuttling between vacation homes or simply traveling to another nearby state - to try and secure earlier access to one of the Pfizer or Moderna COVID jabs.
In the latest confirmation that the mRNA vaccines produced by Pfizer and Moderna will be for the privileged few, while the rest of the world will need to make do with AstraZeneca's jab or, worse, the SinoVac jab (or a jab produced by another Chinese company closely tied to the state). Bloomberg reports that "vaccine tourism" is officially "a thing" in the US...though we don't know exactly how many people are engaging in the practice, various states have witnessed rising numbers of people engaging in the practice.
Beach resort towns in southern Florida and Hawaii, along with ski towns out in Colorado (as well as suburban New Jersey and Connecticut, for the thousands of wealthy New Yorkers doubtless engaging in the process) have been struggling to ensure that the doses - which are, at least for now, still technically federal property - end up with local residents, though many states and localaities added that they won't refuse patients who meet the eligibility requirements.
Frustrated by crashing appointment websites, shortages of Covid-19 shots and a patchwork of confusing eligibility rules, people with time and money are heading out of town in pursuit of a potentially life-saving inoculation.
Vaccine-seeking tourists are showing up in Miami, at beach resorts in Hawaii, ski towns in Colorado and in New York City, which has received more doses than other parts of the state, as well as nearby New Jersey and Connecticut.
There is no national data, yet states that keep track suggest that tens of thousands of Americans are traveling for the vaccine. More than 37,000 out-of-staters have received Covid-19 shots in Florida, according to state data as of Tuesday. The figure excludes people who have second residences or businesses in Florida, where about 1 million have been vaccinated.
Even though refusal numbers across the US have been surprisingly high for both health-care workers, and long-term care home residents (it even force Gov. Cuomo to loosen eligibility restrictions in New York as vaccines were being left to rot on the shelves), this new vaccine tourism trend raises "ethical concerns," according to Bloomberg.
More than 17 million doses have been administered across the U.S., according to Bloomberg’s vaccine tracker. Health policy experts say that, generally, the more people with shots in arms, the better. Yet vaccine tourism raises concerns over what happens to people who don’t have the money—or aren’t healthy enough—to travel for immunization. There are also ethical questions about whether it’s right to appropriate a dose intended for a specific city or state. The tourism industry hasn’t launched large marketing campaigns, so as to avoid appearing to advocate skirting the rules.
Though, at this point, with the high number of refusals seen over the last few weeks, health-care policy experts are conceding that there's no practical downside to getting "shots in arms", as they say.
Health experts also have concerns about people traveling for immunization.
"Everything we can do to get more people vaccinated will decrease the spread of Covid,” said Marissa J. Levine, a public health professor at the University of South Florida. “But we’re in a situation where demand is outstripping supply significantly, so that puts people on edge if they perceive that others are coming in to take their vaccine, even if it’s really all of our vaccine."
Vaccines are technically federal property that don’t belong to any one locality, making residency requirements hard to enforce, said Levine, who served four years as Virginia’s state health commissioner.
Ski towns have attempted to limit vaccination to residents - with some success - to ensure people will still be around to get their second shot a few weeks later.
Aspen’s Pitkin County says those eligible for the vaccine must live or work there.
In some places, like Deer Park, Utah, local officials are even asking workers from outside the area to come there and get the shots.
Now, Pfizer is reportedly saying it would be willing to sell doses directly to the states, surpassing the federal government in a way that Gov Andrew Cuomo of New York has asked Pfizer to do. Technically, all vaccine doses right now are federal property. But that might soon change, opening up new opportunities to get those numbers up - and profits along with them.
