The World Health Organization wants to visit China “as soon as possible” to study the origins of the new coronavirus, WHO Director-General Tedros Adhanom Ghebreyesus said.
“We are planning and hope to be on the ground as soon as possible,” he told a news conference.
Airlines battered by COVID-19 are prepping for key roles in the mass vaccine rollout that promises to unlock an immediate boost for the sector - and beyond that, its own recovery and survival.
Big challenges await carriers leading the airlift, as well as the drugmakers, logistics firms, governments and international agencies planning the deployment across networks blighted by the pandemic.
The gargantuan effort should nonetheless help airlines involved to trim their crisis losses, experts say, while bringing additional benefits to the broader sector, from supporting cargo pricing and revenue to restoring routes.
Developing vaccines in record time was the easy part, or “the equivalent of building base camp at Everest”, according to World Health Organization vaccines director Kate O’Brien.
“The delivery of these vaccines, the confidence in communities, the acceptance of vaccines and ensuring that people are in fact immunized with the right number of doses - (this) is what it’s going to take to scale the peak,” she said recently.
Britain is about to become the first country to begin administering the Pfizer-BioNTech jab, which requires storage below minus 70 Celsius. Moderna’s shot, stored at -20C, is close behind.
In line for major roles are freight specialists and airlines with large cargo arms - such as Germany’s Lufthansa, Air France-KLM and Hong Kong-based Cathay Pacific - often under contract for forwarders and integrators like UPS, Fedex and DHL.
Gulf carriers Qatar Airways and Emirates as well as Turkish Airlines, all slammed by the long-haul travel collapse, can leverage their vast connecting hubs. Turkish has begun flying China’s Sinovac vaccine to Brazil and, like many peers, is increasing its cold chain capacity and storage.
While the earnings windfall is “difficult to quantify”, Cathay commercial chief Ronald Lam told analysts recently, “there will be a positive impact either directly through vaccine transportation or the surge in overall cargo demand.”
Freight is already a bright spot. Many airlines are making unprecedented cargo profits in 2020 even while chalking up record losses overall.
Before the crisis, half the world’s air cargo travelled on some 2,000 freighters, and the rest on passenger jets.
So as lockdowns grounded flights, cargo rates soared, helping carriers keep remaining passenger routes open and avoid more red ink. Cargo’s share of revenue will triple to 36% this year as prices or yields rise 30%, airline body IATA projects.
“The profit margins of all the cargo operations will be very strong in 2020 as a result of the extraordinary circumstances, and will be sustained at that level in 2021 as a result of the vaccine distribution,” HSBC analyst Andrew Lobbenberg said.
Carriers joining the airlift can expect “a very significant impact on the cargo economics”, he said in a note.
Flying one dose to every human would fill 8,000 747s, IATA estimates. While a minority of vaccine deployments may not need air transport, many require two shots per person.
Some freight operators are already seeing other goods bumped off flights by vaccines, trade newsletter The Loadstar reported here.
“There’s a lot less air capacity in the market,” United Airlines cargo chief Christopher Busch told Reuters. “So we need to balance not only what vaccines are coming, but how we continue to move the product that was moving before.”
DISRUPTION RISK
IATA, representing 290 airlines, warns that vaccine rollout could be “compromised” without an easing of the travel curbs and quarantines it has lobbied against.
“There are parts of the world that have no cargo operations once the passenger networks are grounded,” IATA head of cargo Glyn Hughes said.
But UNICEF, whose polio and other immunization campaigns were initially hit by lockdowns, believes lessons have been learned and is now focused on resisting cargo price hikes, as it sources COVID-19 vaccines for 92 poorer countries.
The U.N. children’s agency is having an “early conversation” with airlines to plan capacity and keep rates down, said transport chief Pablo Panadero, who still sees prices as high as twice pre-crisis levels.
“Of course we as UNICEF are making them aware of the humanitarian and even societal importance of these undertakings - this is getting their own industry back in business,” he said.
Cargo carriers may face reputational risk if they use the full clout of their current pricing power, observers warn.
“It’s not a good look to be seen to be profiteering,” said Frederic Horst, managing director of Cargo Facts Consulting.
But Horst expects no repeat of the scramble for masks and medical equipment earlier in the pandemic, when “a lot of government-organised charters were bringing this stuff in, and they were just overpaying.”
This time the airlift will be run by logistics firms who make smarter customers, he said.
“They understand when they’re being pulled over the table and will just go to another carrier.”
A top U.S. scientist overseeing COVID-19 vaccine trials expects a large U.S. study to determine how effective AstraZeneca’s experimental inoculation is, following perplexing results from other trials released by the company and partner Oxford University.
AstraZeneca Plc is one of the leading vaccine developers, but interim data released Nov. 23 from trials in Britain and Brazil showed a vastly divergent performance when the vaccine was tested in two different dose combinations.
According to the company, a small group of trial subjects inadvertently received a half dose followed by a full dose, instead of the planned two full doses. In that group, the vaccine proved to be 90% effective at preventing illness. But the larger group that received two full doses showed a 62% success rate.
Although 62% efficacy is above the benchmark set by regulators to declare a COVID-19 vaccine a success, it pales when compared with efficacy of 95% and 94.1% demonstrated in large trials for vaccines from Pfizer Inc and Moderna Inc, respectively.
A U.S. study of AstraZeneca’s vaccine involving some 30,000 volunteers is in the works and should produce data by late January.
“We feel very comfortable that we designed a really good trial in the United States, where everybody’s getting boosted in a uniform time, and we know what the dose is,” said Dr. Larry Corey, co-leader of the U.S. Coronavirus Vaccine Prevention Network, who helped design and is overseeing trials for the U.S. government Operation Warp Speed program.
The dosing in the British trial “wasn’t done correctly,” Corey maintains. Still, the dosing difference does not fully explain the variation in effectiveness seen in the UK and Brazilian trials, he said.
“One of the issues with the Oxford data is that there’s a lot of lack of uniformity in the schedule and the dose that makes interpretation of the results difficult at best,” he said in a phone interview.
There were also differences in the intervals between doses in the UK trial versus the Brazilian trial, as well as significant differences in the age range included in the studies. For example, everyone in the 90% effective group was under the age of 55, a group less susceptible to severe COVID-19.
“My personal summation is that there seems to be effectiveness in the AstraZeneca vaccine from this other trial that provides optimism that the current trial in the United States will define that effectiveness,” he said.
Moncef Slaoui, chief adviser for the Operation Warp Speed vaccine program, said last week the British and Brazilian trials may not be enough to ensure the vaccine receives a U.S. Food and Drug Administration emergency use authorization.
Results and potentially a request for U.S. emergency use authorization by AstraZeneca could come in late January, he said.
AstraZeneca has said it is considering a new global trial based on the half dose first regimen.
The U.S. trial calls for testing the original regimen of two full doses.
Should AstraZeneca decide to run a new U.S. trial testing the half dose first option, Corey said, the United States was unlikely to help foot the bill.
“Companies get to decide what they want to do,” he said. “I’m sure they’ll have to fund it themselves, or maybe somebody else would fund it for them.”
scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced it received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) on December 3, 2020 regarding the Company’s New Drug Application (“NDA”) for FUROSCIX®.
In the CRL, the FDA cited their need to conduct pre-approval inspections at two of the company’s third-party manufacturing facilities that could not be conducted due to travel restrictions. In addition, the FDA raised questions related to testing, labeling, and features of the combination product unrelated to the drug constituent. In addition, the FDA indicated that there were deficiencies at the third-party facility where the Company’s off-the-shelf alcohol swabs are manufactured. scPharmaceuticals will request a Type A meeting with the FDA to discuss the issues described in the CRL and steps required for the resubmission of the NDA for FUROSCIX®.
scPharmaceuticals ended the third quarter with cash, cash equivalents, restricted cash, and investments of $114.5 million, which the Company estimates is sufficient to fund operations into 2023 at the projected burn rate.
John Tucker, Chief Executive Officer of scPharmaceuticals, stated: “While we are disappointed that these on-site inspections, and other issues raised in the CRL, will not be resolved by our previously granted December 30, 2020 PDUFA date, we are committed to working with our manufacturing partners and responding to the agency’s concerns as expeditiously as possible. We continue to believe that FUROSCIX® can play a significant role in preventing heart failure hospital admissions and readmissions due to fluid overload by intervening with this novel therapy at home.”
Best objective response rate of 87% reported for 15 patients with relapsed/refractory mantle cell lymphoma, with a median follow-up of 12.1 months. Median progression-free survival (PFS) was not reached
The combination of cirmtuzumab and ibrutinib has been well tolerated in this trial
