Rite Aid Corp. RAD,
Tuesday, November 24, 2020
Rite Aid to charge $115 per COVID-19 test from Dec. 1 as fed funding ends
91.4% efficiency for Sputnik V vaccine on Day 28 after 1st dose, over 95% 42 days after
The efficacy of the Sputnik V vaccine is 91.4%, based on the second interim analysis of data obtained 28 days after administering the first dose (7 days after the second dose).
Calculation was based on the analysis of data on volunteers (n = 18,794) who received both the first and second doses of the Sputnik V vaccine or placebo at the second control point (39 confirmed cases as of November 23, 2020) in accordance with the clinical trial protocol.
Preliminary data from volunteers obtained 42 days after the first dose (corresponds with 21 days after the second dose) indicates an efficacy of the vaccine above 95%.
The interim research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals. Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report.
Currently, 40,000 volunteers are taking part in the Phase III double-blind, randomized, placebo-controlled clinical post-registration study of the Sputnik V vaccine in Russia, of whom more than 22,000 volunteers were vaccinated with the first dose and more than 19,000 volunteers with the first and second doses.
There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing.
The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades - while the history of the use of human adenoviruses in vaccine development began in 1953. More than 100,000 people have received approved and registered drugs based on human adenoviral vectors.
The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.
Bristol Myers Squibb Gets EU Approval of Opdivo in Esophageal Cancer
Bristol Myers Squibb Co. on Tuesday said the European Commission approved its cancer drug Opdivo as a second-line treatment for certain forms of esophageal squamous cell carcinoma, making it the first immunotherapy to be approved for a gastroesophageal cancer in the European Union.
The New York biopharmaceutical company said the approval covers Opdivo for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy.
Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers, the company said. In addition to the EU, the drug has been approved in five countries, including the U.S. and Japan, for the second-line treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma.
Mexico aiming to start COVID-19 vaccinations in December
Pharmaceutical company Pfizer Inc’s COVID-19 vaccine could start being administered in Mexico in mid-December if it is approved by the country’s health regulator, Mexico’s foreign minister said on Tuesday.
Pfizer was scheduled to submit details on the vaccine’s use to regulator Cofepris on Tuesday and Wednesday, allowing the regulator to begin its analysis in line with its U.S. counterparts, Foreign Minister Marcelo Ebrard told a regular news conference.
“Pfizer - if Cofepris approves - will reach Mexico in December of this year,” Ebrard added on Twitter.
Pfizer last week applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization of its COVID-19 vaccine. The FDA will discuss the emergency use authorization on Dec. 10.
Once the vaccine is approved in Mexico, Ebrard said it would take about five days for a shipment to arrive in Mexico from laboratories in either the United States or Europe.
“It’s good news for Mexico. We’re going to start just with a short gap behind the United States and Germany,” Ebrard told the news conference.
Mexico has pre-ordered several different vaccines, both through the WHO-backed COVAX program and bilaterally.
While Pfizer may be the first to get approval, AstraZeneca’s offering could end up being more widely distributed since it will be partly made in Mexico and does not require such cold storage.
“The logistics of distribution will be more simple relatively,” Ebrard said.
Mexico is also conducting large-scale Phase 3 trials at 19 test centers for the Chinese CanSino Biologics Inc candidate, and expects to start similar trials for Johnson & Johnson’s Janssen unit once the first doses arrive this week and Cofepris authorizes the trial, Ebrard said.
The regulator is studying a request by U.S. laboratory Novavax Inc to conduct late stage trials in Mexico, and Germany’s CureVac NV is studying the possibility of Mexican trials, he said.
CDC may soon shorten COVID-19 quarantine period
The U.S. Centers for Disease Control and Prevention may soon shorten the length of self-quarantine period after potential exposure to the coronavirus, a top official said on Tuesday.
Health authorities currently recommend a 14-day quarantine in order to curb transmission of the virus but an official said Tuesday that there is evidence that the period could be shortened if patients are tested for the virus during their quarantine.
“Let me confirm that we are constantly reviewing the evidence and we are starting to have evidence that a shorter quarantine complemented by tests might be able to shorten that quarantine period from 14 days to shorter days,” a top U.S. health official said on a Tuesday press call.
He added that the decision to change the guidance is not final and experts are still reviewing data to make sure such a change would not put people at risk.
The U.S. government has been criticized by experts and public health officials for being slow to ramp up COVID-19 testing.
It has also distributed nearly 40 million out of 150 million rapid tests it agreed to acquire from Abbott Laboratories earlier this year, the officials said.
New coronavirus cases in the United States are averaging nearly 172,000 a day and have exceeded 100,000 since early November, according to a Reuters tally.
U.S. total deaths due to coronavirus reached nearly 259,000 on Tuesday with over 12.5 million cases.
UPS to be a dry ice hero in vaccine distribution efforts
- UPS (UPS +3.4%) is out with a timely announcement on enhancements it is making to help with the massive distribution efforts for COVID-19 vaccines.
- The company says its UPS Healthcare business can now produce up to 1,200 lbs. of dry ice per hour in its U.S. facilities to support the storage and transportation of cold chain products, such as frozen vaccines.
- The increased production also allows UPS to make dry ice available for U.S. and Canadian hospitals, clinics and other points of care requiring dry ice to store vaccines locally. Dry ice will be sourced at UPS Worldport and can be available next day.
- As has been reported, a major spike in demand is causing logistics providers to plan around a feared dry ice shortage, as pharmaceutical companies prep to get millions of their vaccine doses safely distributed in the U.S. and internationally.
- Source: Press Release
- https://seekingalpha.com/news/3639169-ups-to-be-dry-ice-hero-in-vaccine-distribution-efforts
Russia, eyeing foreign markets, says Sputnik COVID-19 vaccine to cost under $20
Russia’s Sputnik V COVID-19 vaccine will cost under $20 per person on international markets and Moscow aims to produce more than a billion doses at home and abroad next year, its financial backers and developers said on Tuesday.
The Sputnik vaccine, named after the Soviet-era satellite that triggered the space race in a nod to the project’s geopolitical importance for Moscow, is administered in two shots, each of which will cost less than $10, according to the official Sputnik V Twitter account.
For Russian citizens, inoculation will be free of charge. Mass vaccination in Russia, which has the world’s fifth-highest number of recorded COVID-19 cases, has yet to begin as so-called Phase III clinical trials continue.
The Kremlin said on Tuesday that President Vladimir Putin had yet to be vaccinated with Sputnik V. His position meant he could not take something that was still being trialled, it said. One of his two daughters had taken it however, Putin disclosed in August, and felt fine afterwards.
Russia's pricing announcement comes as Russia looks to scale up distribution and production and as three vaccines, one by AstraZeneca, another by Pfizer/BioNTech PFE.N and a third by Moderna, have emerged in the West, raising hopes that the global pandemic can be tamed next year.
Moscow, keen to win global market share, touted the international price for Sputnik V as competitive.
“It’s more than twice as cheap as other vaccines that have the same efficacy levels,” Kirill Dmitriev, head of Russia’s RDIF sovereign wealth fund, told a briefing.
“Right now, Sputnik V is the cheapest vaccine with an efficacy level above 90% in Phase III clinical trials”.
The price of the Russian vaccine is cheaper than some other Western rivals such as the vaccine produced by Pfizer-BioNTech, which costs 15.5 euros per shot, but more expensive than the vaccine developed by AstraZeneca and the University of Oxford, which will be sold in Europe for around 2.5 euros per shot.
Russia plans to produce around 2 million doses of Sputnik V this year, and Dmitriev said Moscow and its foreign partners had capacity to make more than a billion doses starting from next year, enough to vaccinate more than 500 million people.
Over 50 countries had made requests for more than 1.2 billion doses, he said. Supplies for the global market would be produced by partners in India, Brazil, China, South Korea, Hungary and other countries.
‘FREEZE-DRIED AND EFFECTIVE’
Production of a new freeze-dried form of the vaccine, which means it can be stored in a fridge and is easier to distribute, was also under way, he said, something he said he believed would make it attractive for countries in Africa and Asia.
Talks were also ongoing with other foreign partners on increasing production, he added.
RDIF and the Gamaleya National Center said earlier on Tuesday that new clinical trial data based on 39 confirmed cases and 18,794 patients who had both shots had shown that Sputnik V was 91.4% effective on day 28 and over 95% effective on day 42.
That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.
The data would be published in a leading scientific journal next month for experts to scrutinise, Dmitriev promised.
The Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.
Russia’s healthcare system is under heavy strain, the Kremlin said on Tuesday, as authorities reported a record 491 deaths linked to COVID-19 and infections surged.
Russia has been criticised by some scientists in the West who have accused it of cutting corners in an effort to try to rush out the vaccine and complained about the amount of data available to allow others to interpret its research.
In particular, some Western scientists have criticised Moscow for giving the regulatory go-ahead for the shot and launching mass vaccinations before full trials had been completed.
Russia has rejected such criticism and insisted that it is doing everything safely and responsibly. It alleges a Western dirty tricks campaign to put people off its vaccine in what it believes has become a battle for legitimacy and market share.
Dmitriev on Tuesday praised Western success at developing vaccines, saying the world would need different vaccines. He said Russia was ready to share its know-how with manufacturers such as AstraZeneca if helpful.
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