Many infection preventionists said they've seen an uptick in healthcare-associated infections at their facilities since the pandemic's start, according to a Dec. 3surveyfrom the Association for Professionals in Infection Control and Epidemiology.
The survey is based on 1,083 responses collected from infection preventionists nationwide between Oct. 22 and Nov. 5.
Four survey findings:
1. Infection preventionists most commonly reported increased rates for central line-associated bloodstream infections (27.8 percent), catheter-associated urinary tract infections (21.4 percent) and ventilator-associated pneumonia or ventilator-associated events (17.6 percent).
2. Nearly 73 percent of respondents said their facilities have implemented PPE crisis standards of care for respirators, while 68.7 percent said the same for masks and 75.8 percent for eye protection.
3. About 73 percent of infection preventionists said their facilities permit staff to reuse respirators for five days or more before they get new ones, and 73.6 percent reported the same for masks.
4. Seventy-two percent of infection preventionists said they were strongly or somewhat concerned about their facility's surge capacity.
The contingent value right (CVR) issued to Celgene shareholders as part of its $74B merger with Bristol Myers Squibb (BMY.RT+106.7%) is up big today although still down ~13% year to date. Volume is 63.5M, more than 7x normal.
Investors apparently have renewed confidence of FDA approval of CAR T therapy lisocabtagene maraleucal (liso-cel) for relapsed/refractory large B-cell lymphoma patients who have received at least two prior lines of treatment by the end of the month, the deadline for one of the two qualifying milestones for a $9 payout. The action date has been delayed until the FDA can inspect the manufacturing plant, an otherwise routine action that it has been unable to complete due to COVID-19-related travel restrictions.
The other milestone is a U.S. nod by March 31, 2021, for CAR T idecabtagene vicleucel (ide-cel) (bb2121) for multiple myeloma patients who have received at least three prior lines of treatment. The agency's action date for its review of the marketing application is March 27.
The Moderna Analyst: BofA Securities analyst Geoff Meacham reiterated a Neutral rating on Moderna shares and increased the price target from $105 to $150.
The Moderna Thesis: While Moderna's pipeline is promising, the sustainability of COVID-19 revenue in the longer term is still in question, Meacham said in a Thursday note.
BofA also tempered any broad read-across of the COVID-19 prospects to the rest of pipeline, the analyst said.
The firm's updated base case assumes $10 per share in cash, $62 per share in non-COVID-19 value and $78 per share in COVID-19 vaccine revenue, he said.
Even in a bull case where mRNA-1273 is broadly available globally, with limited competition and manufacturing constraints, the cumulative sales value of over $85 billion attributed by the market is a stretch, Meacham said.
Any value realized should come from bulk contracts, where the company will face limited pricing power and negative optics from overcharging, especially as additional vaccines are approved, the analyst said.
The Street estimates assume that more than 150 million individuals will be revaccinated each year with mRNA-1273, which is also questionable, he said.
The manufacturing scale-up could pose problems, with demand likely to outstrip supply for the next few years, Meacham said.
In order for valuations to be warranted at the share price peak of $178, either the COVID-19 vaccine should fetch cumulative revenue of over $85 billion between now and 2030, or the vaccine approval should substantially derisk the rest of Moderna's pipeline, according to BofA.
The latter possibility is difficult given the lack of concrete data, the firm said.
Study results announced this month proved experimental coronavirus vaccines fromPfizer,ModernaandAstraZenecacan prevent COVID-19. The next challenge will be shipping hundreds of millions of doses around the world as countries prepare to vaccinate their citizens.
Each step along transcontinental supply chains for delivery of those doses is vital and freight forwarders — the often behind-the-scenes transport companies that make the global economy hum — are the linchpins. They will ensure vaccine supplies are moved securely from pharmaceutical factories to health authorities, hospitals and clinics. For the leading vaccines, that means keeping doses cold and, in Pfizer's case, very, very cold.
"We refer to this as the biggest product launch in the history of mankind," said Neel Jones Shah, head of airfreight for Flexport, a California-based freight forwarder. "This is the top end of complexity of anything we've ever done before."
With billions of people needed vaccination globally, some freight forwarders don't feel ready for the challenge.
"The industry as a whole is not prepared or doesn't feel comfortable with the type of requirements thrust upon them," said Jones Shah.
Part of that concern is because drugmakers are keeping some shipping requirements close to the vest, said Jones Shah, a TIACA board member. General temperature and storage requirements are known, but a lot of other information remains unclear, such as needed transportation modes, vaccine destinations and the number of doses or pallets that will be shipped at any given time.
"As we get new pieces of information, we're able to add more specificity to the plan about how it will get moved from A to B," Jones Shah said.
The devil in the details
Vaccine transport is nothing new to freight forwarders who work with pharma. The difference this time is the high volume of vaccines to distribute, and the low temperatures required to keep coronavirus vaccines like Pfizer's stable.
"Freight forwarders coordinate the entire move. There's not one company that typically controls all access to do that," Jones Shah said. "Freight forwarders are the glue that connects all the asset owners together."
Pfizer, which partnered with German drug developer BioNTech, was the first to announce Phase 3 results for its vaccine, disclosing preliminary findings on Nov. 9 and then final efficacy data on Nov. 18. The companies will use DHL, FedEx and UPS to deliver doses via truck and plane, in reusable containers topped off with dry ice, that can maintain the necessary temperature of minus 70 degrees Celsius.
Pfizer said the vaccines will be shipped directly from the manufacturing site to the vaccination site. The company is bypassing distribution by McKesson, a large drug distributor tapped by the U.S. government to help handle vaccines successfully developed under the "Operation Warp Speed" initiative.
By choosing not to partner with McKesson, Pfizer is taking more direct control of the shipping process, betting that it can get doses to their destinations faster on its own. Avoiding additional loads and unloads at central distribution hubs, for instance, could help the company better maintain the temperature of the frozen doses.
Pfizer's most recent projections are for 50 million doses to be manufactured by the end of 2020, and as many as 1.3 billion in 2021. By comparison, 175 million flu vaccine doses were distributed in the U.S. during the 2019 to 2020 flu season, according to the Centers for Disease Control and Prevention.
Add in forecasted vaccine production from Moderna, AstraZeneca and other companies quickly advancing experimental candidates, and the demand for transport will test the global supply chain's limits. Differences in temperature and in the number of doses contained in each vial could matter greatly, however.
The International Air Transport Association estimates 8,000 full 747 flights would be needed to ship a single dose vaccine for the world's 7.8 billion people. (Pfizer's, Moderna's and AstraZeneca's shots each require two doses. Some, like one from Johnson & Johnson, need only one.)
An analysis by DHL puts the number at 15,000 flights for 10 billion doses, and forecasts the task would involve as many as 200,000 pallets and 15 million deliveries in cooling boxes.
If vaccine doses can be transported at 2 to 8 degrees Celsius, with multiple doses per vial, a model developed by Seabury/Accenture and Kuehne + Nagel estimates fewer than 1,000 full 747 freighters would be needed, said Robert Coyle, a senior vice president at Kuehne + Nagel.
The cold chain remains a big challenge. While Pfizer is confident it can ship its vaccine at the correct temperature, there are concerns that hospitals and clinics won't have enough deep freezer capacity to store doses.
"The colder the storage requirement, the more complicated the logistics," said David Goldberg CEO of DHL Global Forwarding USA.
Pfizer designed its own packaging, which will use dry ice to maintain temperature outside of specialized appliances. But restrictions on how often the packaging can be opened could present healthcare workers administering the shot with new problems.
Moderna's vaccine, by contrast, can remain stable at 2 to 8 degrees Celsius — the temperature of a standard refrigerator — for up to 30 days, but must be stored at minus 20 degrees Celsius for longer term preservation. Pharmaceutical distribution companies have this capability now.
Few air carriers are able to ship at temperatures of -80 degrees Celsius or lower
% of respondents to the question: Is your organization currently able to handle/store/transport temperature-controlled shipments?
The U.S. is also experiencing dry ice shortages, due in part to lower ethanol production with fewer cars on the road. Dry ice is a byproduct of that process.
"You can't stockpile [dry ice] because it evaporates. We're working with manufacturers to make sure we have sufficient capacity," Goldberg said.
Airplanes have limitations for how much dry ice can go on an airplane, however.
"It turns into carbon dioxide when it sublimates. You can't pack an airplane full of dry ice — it's harmful for the crew," said Jones Shah.
Vaccines stored at 2 to 8 degree Celsius, like Moderna's and AstraZeneca's, don't need dry ice. The vials can be sent in a temperature-controlled container that holds a battery charge and keeps the contents at a consistent temperature. The container's battery is then recharged on arrival.
Manufacturer
Temperature requirement
AstraZeneca, Univ. of Oxford
2 to 8 degrees Celsius
Moderna
2 to 8 degrees Celsius short term, minus 20 degrees Celsius long term
Pfizer, Biontech
minus 70 degrees Celsius
Source: Companies
The containers are not new for coronavirus vaccines and are already used to move other vaccines and temperature-sensitive products. With a greater number of vaccines to transport, however, more containers will be needed at any one time.
And not all airports have enough plugs to recharge them in large numbers, said Christos Spyrou, CEO and founder of Neutral Air Partner, and a TIACA board member. That means ensuring the airports have the appropriate support, or the freight forwarder has nearby storage capacity. Kuehne + Nagel identified 32 pharmaceutical hubs globally with airside solutions, Coyle said.
Shippers and freight forwarders are also using sensors and GPS trackers to monitor products throughout the journey and ensure they remain within the temperature spectrum.
"We have people on the ground working with baggage handlers making sure the temperature range doesn't get out of control," Coyle said.
According to IATA, a majority of pharmaceutical damage occurs via temperature changes during transport on airplanes or at airports. The association estimates a $34.1 billion annual loss as a result.
A Kuehne + Nagel employee labels a package with temperature requirements.
Courtesy of Kuehne + Nagel
Warehousing and the last mile
Freight forwarders and carriers also must keep vaccines cold en route to the airport and while waiting for transit.
UPS is building freezer farms near air hubs in the U.S. and the Netherlands, adding 600 freezers that can hold 48,000 vaccine vials at minus 80 degrees Celsius.
DHL Global Forwarding, meanwhile, opened a 20,000-square-foot cold chain facility in Indianapolis, with three temperature-controlled chambers, the lowest at minus 20 degrees Celsius. Goldberg said DHL has four other cold chain facilities in the U.S.
Kuehne + Nagel is building key hubs with temperature flexible capacity, like ones that recently opened in Brussels and Johannesburg, which can be used for airfreight and distribution.
A key question is how vaccine doses will be shipped and delivered to countries with less established healthcare supply chains.
Moving the cargo to emerging markets by plane might be easy, but the final mile is not, said Spyrou. Many freight forwarders are buying or considering the purchase of freezer or temperature-controlled boxes to create a final mile vaccine solution. However, "you can't invest unless you know the country would receive a certain type of vaccine," he said.
In the U.S., the recipient will need enough storage capability at the temperature required. Pfizer's vaccines may be sent to larger facilities where clinicians can vaccinate more people in a shorter timeframe, for example, to decrease waste.
In the short term, none of the vaccines will likely sit in a distributor's warehouse for any length of time, given the expected demand. Deliveries will need to be coordinated to ensure storage availability at the inoculation sites.
Truck in front of the Kuehne + Nagel Swiss Pharma Hub, Moehlin.
Courtesy of Kuehne + Nagel
Not all freight forwarders are equal
There's another aspect to the freight forwarder story, and that's how COVID-19 will affect freight forwarder businesses when the vaccines start shipping.
General freight forwarders with no specific niche and those who don't move temperature-controlled products are worried their cargo won't be a priority and might be pushed. Rates may also rise high enough that clients can't afford to ship.
"Pharma is always a priority. When it's vaccine season, other cargo gets bumped," Spyrou said.
Other freight forwarders might ship some smaller amounts of pharmaceuticals, but lack the capacity for large shipment volumes. Freight forwarders in the third-party logistics business that distribute PPE, meanwhile, cannot necessarily adequately support vaccines.
"Pharmaceutical capabilities are not acquired overnight," said Jones Shah.
The U.K.’s monumental approval for Pfizer and BioNTech’s COVID-19 vaccine turned heads worldwide, but one of the leading voices in the U.S. pandemic response argues the country’s regulators acted too quickly.
“If you go quickly and you do it superficially, people are not going to want to get vaccinated,” NIAID director Anthony Fauci told Fox News. "We have the gold standard of a regulatory approach with the FDA.”
The U.K.'s Medicines and Healthcare Products Regulatory Authority (MHRA) "did not do it as carefully," he added.
By rebuking the U.K.’s review process, Fauci offered a defense to the FDA amid pressure on the agency from the Trump administration. Earlier this week, White House chief of staff Mark Meadows summoned FDA Commissioner Stephen Hahn for a meeting on why the vaccine hadn’t been approved.
After the meeting, Hahn himself defended the agency’s review process in a Wall Street Journal interview. The FDA has 150 people working in various teams around the clock on the application, he said, and it's getting ready for a public meeting next week at which independent experts will closely pore over the data.
FDA officials are expected to make a decision in the days following the Dec. 10 meeting. It’s a process that would “typically take us months,” Hahn told the newspaper, but could be complete in under a month after Pfizer’s Nov. 20 filing.
Pfizer CEO Albert Bourla has said the company aims to ship doses “within hours” of approvals, and last month wondered whether a “race to regulate” would ensue as countries vie to get their hands on the first coronavirus vaccine doses.
While Fauci may take issue with the U.K.’s process, scientists at Pfizer and BioNTech praised the country’s drug regulator following the rolling review. In a media briefing this week, Pfizer executive Ralf Rene Reinert said the regulator quickly responded to new data throughout the process, sometimes in around 10 minutes, according to the WSJ. BioNTech’s chief business and commercial officer Sean Marett added that the regulator “asked the same level of detail of questions as any agency.”
Other countries have been in touch to inquire about the U.K.’s process, Reinert also said during the briefing.
Pfizer and BioNTech plan to make around 800,000 doses available in Britain next week, The Guardian reported. The U.K. has ordered 40 million doses from the partners, or enough to vaccinate 20 million people.
In the U.S., officials have said vaccinations could start this month after Pfizer’s Dec. 10 FDA meeting and Moderna’s meeting the following week. Operation Warp Speed head Moncef Slaoui said on CNN the U.S. could reach herd immunity through vaccination by May.
Meanwhile, as the U.S. government continues prepping to change administrations, Fauci said he plans to have a "substantive" conversation with the incoming Biden team, CBS News reports.
Certara (CERT) launches initial public offering of 24.39M common shares, of which 14.63M shares offered by the company and 9.76M shares by certain selling stockholders at an initial expected price between $19-$22 per share.
Selling stockholders to grant the underwriters an option to purchase additional ~3.7M shares.
Incorporated in 2017, the company uses its biosimulation software and technology to conduct virtual trials using virtual patients to predict how drugs behave in different individuals, which it believes can transform traditional drug discovery and development. Its integrated, end-to-end platform is used by more than 1,600 biopharmaceutical companies and academic institutions across 60 countries, including the top 35 biopharmaceutical companies by R&D spend in 2019.
Moscow will open its new COVID-19 vaccination centres on Saturday and the first people to receive the shot will be teachers, doctors and social workers, Mayor Sergei Sobyanin said on Thursday.
President Vladimir Putin on Wednesday ordered a large-scale voluntary vaccination programme against COVID-19 to begin next week across Russia, saying teachers and doctors should be first in line to get the flagship Sputnik V vaccine.
People in Moscow will be able to register for the jab online from Friday, Sobyanin said in a statement on his website.
Russia, which has resisted imposing stringent lockdown measures, reported a record 28,145 new infections earlier on Thursday, including 7,750 in Moscow.
