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Monday, August 9, 2021

South Korea approves Phase III trial of SK Bioscience's COVID-19 vax

 

South Korea gave vaccine developer SK Bioscience the green light on Tuesday for a Phase III study of its COVID-19 vaccine candidate at a time of vaccine shortages, when a spurt in infections is fuelling demand.

The clinical trial of GBP510, the candidate for the first domestic vaccine, will weigh its immunogenicity and safety against AstraZeneca Plc's vaccine, drug safety minister Kim Gang-lip told a news conference.

Three thousand of the 3,990 adults in the trial will receive the experimental vaccine and 990 will get AstraZeneca doses, with an interval of four weeks, Kim said.

In a statement, SK Bioscience said data from early trials of 80 healthy adults who received the two-dose protein-based vaccine showed they all induced neutralising antibodies against the virus.

Shares of the company, which debuted in March, rose as much as 29.5% to hit a record on Tuesday, outperforming a decline of 0.6% in the benchmark index.

SK is also a contract manufacturer of vaccines for AstraZeneca and Novavax Inc.

South Korea, with a tally of 213,987 infections and 2,134 deaths, has fully vaccinated 15.4% of its population of 52 million, largely using doses from AstraZeneca, Pfizer and Moderna Inc.

But on Monday, the government said Moderna would deliver less than half this month's planned shipment, due to production issues.

The government had earlier said seven local drugmakers were set to launch the final phase of clinical trials in the year's latter half.

SK is the world's second firm to try a comparative trial with another vaccine after French biotech Valneva's Phase III trial against the AstraZeneca shot, the drug safety ministry said.

https://www.marketscreener.com/quote/stock/SK-BIOSCIENCE-CO-LTD-120803076/news/South-Korea-approves-Phase-III-trial-of-SK-Bioscience-s-COVID-19-vaccine-36116410/

Moderna may be superior to Pfizer against Delta

 The mRNA vaccine from Pfizer and BioNTech may be less effective than Moderna's against the Delta variant of the coronavirus, according to two reports posted on medRxiv on Sunday ahead of peer review. In a study of more than 50,000 patients in the Mayo Clinic Health System https://bit.ly/37Btmhf, researchers found the effectiveness of Moderna's vaccine against infection had dropped to 76% in July - when the Delta variant was predominant - from 86% in early 2021. Over the same period, the effectiveness of the Pfizer/BioNTech vaccine had fallen to 42% from 76%, researchers said. While both vaccines remain effective at preventing COVID hospitalization, a Moderna booster shot may be necessary soon for anyone who got the Pfizer or Moderna vaccines earlier this year, said Dr. Venky Soundararajan of Massachusetts data analytics company nference, who led the Mayo study.

In a separate study, elderly nursing home residents in Ontario https://bit.ly/3sb9pHJ produced stronger immune responses - especially to worrisome variants - after the Moderna vaccine than after the Pfizer/BioNTech vaccine. The elderly may need higher vaccine doses, boosters, and other preventative measures, said Anne-Claude Gingras of the Lunenfeld-Tanenbaum Research Institute in Toronto, who led the Canadian study. When asked to comment on both research reports, a Pfizer spokesperson said, "We continue to believe... a third dose booster may be needed within 6 to 12 months after full vaccination to maintain the highest levels of protection."

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-COVID-SCIENCE-Moderna-may-be-superior-to-Pfizer-against-Delta-breakthrough-odds-rise-with-36115101/

COVAX is not working

 Last week, Paraguayan President Mario Abdo Benítez spoke with unusual candor about the problems plaguing the world's only multilateral mechanism for equitable COVID-19 vaccine distribution, COVAX. "COVAX did not work," he said of the initiative, operated jointly by the World Health Organization (WHO) and two nonprofits.

Last October, Paraguay made its first payment for an order of 4.3 million vaccine doses from COVAX, which was designed to get countries better prices than deals reached directly with manufacturers. But COVAX had only delivered the country 340,800 doses by the end of July. As of the most recent official data on July 25, just 4 percent of Paraguayans had been fully vaccinated.

"We bet on the COVAX mechanism to generate equity," Abdo Benítez said. "I have to say it with pain. I cannot stay quiet."

Globally, COVAX is running half a billion doses short of its delivery goals. Though one of its architects said COVAX aimed to "ensure that ability to pay does not become a barrier to accessing [vaccines]," the opposite appears to have occurred. Vaccine-makers have been reluctant to sell to COVAX, and wealthy countries bypassed the initiative to scoop up much of manufacturers' available supply in direct deals. And there has been little technology transfer to expand global vaccine production, meaning that a delay at one plant can cause huge backups that ripple around the world.

Global vaccine distribution has overwhelmingly functioned according to the preferences of pharmaceutical companies and wealthy countries, rather than through an equity-based system. Though the United States, the largest vaccine donor to date, says it allocates doses based on criteria aimed at saving lives, it is doing so at a scale that is a mere one-hundredth of what the WHO says is necessary to get the pandemic under control globally.

Now, as the delta variant takes hold, several Latin American policymakers are scrambling to redefine their vaccine strategies and boost local production.

Seeking new supply. With its COVAX shots delayed, Paraguay has secured new contracts with Pfizer and Moderna. The Dominican Republic, which also complained about COVAX delays, increased its orders from China's Sinovac.

These moves have come with their own challenges. An official from Paraguay, which diplomatically recognizes Taiwan, said a subsidiary of Chinese manufacturer Sinopharm canceled a vaccine contract for "geopolitical reasons," while Pfizer reportedly pressured Latin American governments to sign over unprecedented sovereign assets as guarantees against the cost of potential lawsuits.

Countries have also slowly worked to build local production capacity. A plant in Argentina had its first full course of locally produced Sputnik V doses approved for quality this week. Cuba is exporting its homemade vaccine Abdala to Venezuela and may soon send it to Bolivia, while Brazil's Butanvac and Mexico's Patria shots are in clinical trials. On Wednesday, Chile announced plans to build a plant that will fill and finish doses of Sinovac's vaccine.

At the request of the Community of Latin American and Caribbean States, the United Nations' Alicia Bárcena presented the group with a road map to strengthening regional vaccine access at its annual meeting last week. It includes collaborating on intellectual property (IP) access and bringing more production capacity online.

Weighing compulsory licensing. While negotiations on a special IP waiver for COVID-19 health technologies are stalled at the World Trade Organization (WTO), an existing WTO agreement already permits countries to sidestep pharmaceutical patents and other IP rights in certain emergencies. Chile, Colombia, and Ecuador have passed resolutions facilitating this process in the face of COVID-19.

In Brazil, President Jair Bolsonaro's executive branch has opposed an IP waiver. But the country's legislature is in the final stages of approving a bill that would allow Congress to issue compulsory licenses according to WTO agreements, permitting local firms to produce and export COVID-19 vaccines and therapeutics without the patent holders' consent. Brazil used the threat of such licenses in the early 2000s to pressure pharmaceutical companies to lower HIV drug costs.

The Brazilian bill is backed by groups ranging from AIDS activists and Black activists to center-right senators—a sign of the broad support that remains in the country for this kind of measure.

The cost of current trends. Health experts have warned that, the slower the rate of vaccination around the globe, the more likely it is that new—and potentially more lethal—variants of the coronavirus will develop. The International Monetary Fund (IMF) estimates that a roughly $50 billion push to vaccinate 40 percent of all countries' populations by the end of 2021 and 60 percent by mid-2022 will bring $9 trillion in global GDP gains.

Continuing vaccinations at their current scale has consequences for political stability and migration, too. For example, more Nicaraguans were encountered at the US southern border in the last three months than in any 12-month period in the last 20 years. Political repression in Nicaragua plays a role in this, but so too does the fact that Costa Rica's tourism-focused economy, where Nicaraguan migrants usually seek work, remains hard-hit by COVID-19.

Germany to stop free COVID-19 tests - report

 Germany wants to end free coronavirus tests in October, the RND group of newspapers reported on Monday, citing a draft proposal to be discussed by Chancellor Angela Merkel and leaders of the country's 16 states.

The government made the tests free for all in March to make a gradual return to normal life possible after a lockdown to break a third wave of COVID-19.

But with 55% of the population fully vaccinated there have been calls to stop spending taxpayers' money on a subsidised scheme that now mainly benefits those who are not yet vaccinated even though vaccines are available for all.

"Given that all vaccination is immediately available to all citizens, it is no longer justifiable that the federal government and therefore taxpayers cover the cost of all tests," RND cited from a draft proposal.

Less than seven weeks before a federal election, Merkel and state leaders will discuss measures to keep rising new infections spurred by the Delta variant in check without instituting lockdowns.

The draft stipulates that people who cannot be vaccinated for health reasons like expectant women and children under 18 will continue to be entitled to subsidised tests.

An exact date in October for curtailing the program has not yet been made, RND added.

Germany has recorded more than 3,000 cases on each of the past five days but with almost 63% of the population having received at least one shot the government is hoping lockdowns could be avoided.

https://news.yahoo.com/germany-stop-free-covid-19-201833438.html

U.S. settles scientist's whistleblower complaint about Trump COVID-19 response

 The U.S. government has agreed to compensate a scientist who filed a whistleblower complaint that said former President Donald Trump's administration botched its early response to the coronavirus pandemic, the scientist's lawyer said on Monday.

Dr. Rick Bright, formerly of the U.S. Department of Health and Human Services, reached a settlement with the agency, lawyer Debra Katz said.

The settlement resolves Bright's "allegations that HHS retaliated against him for blowing the whistle about the Trump Administration’s inadequate and irresponsible response to the coronavirus pandemic," Katz said in a statement.

Neither side disclosed specifics of the settlement, but Katz said "Dr. Bright has been compensated to the fullest extent allowed by the law" and "will receive back pay and compensatory damages."

The U.S. Office of Special Counsel, an independent government agency that hears whistleblower complaints, said in a statement that it helped facilitate a "mutually agreeable resolution."

HHS did not immediately respond to a request for comment.

Bright was removed in April 2020 as director of the Biomedical Advanced Research and Development Authority, or BARDA, a part of HHS responsible for developing drugs to fight the coronavirus.

Bright said he was removed and demoted because he raised concerns about pandemic preparedness.

HHS has disputed Bright’s account, saying last year he was transferred to a job where he was entrusted to spend around $1 billion to develop diagnostic testing.

Bright testified at a congressional hearing in May 2020 that he would "never forget" an e-mail he got in January 2020 from a U.S. supplier of medical-grade masks warning of a dire shortage.

"He said ‘we are in deep shit. The world is. We need to act,’" Bright told lawmakers. "And I pushed that forward to the highest level that I could of HHS and got no response."

Bright said he was ousted from BARDA in part because he resisted efforts to push the drug hydroxychloroquine as a cure for COVID-19, something advocated by Trump himself.

https://news.yahoo.com/u-settles-scientists-whistleblower-complaint-192614263.html

CDC advisers to review data on COVID-19 vaccine boosters

 A U.S. Centers for Disease Control and Prevention (CDC) advisory panel will meet on Friday to discuss considerations for booster doses of COVID-19 vaccines, as the United States deals with increasing cases from the Delta variant of the coronavirus.

The meeting of CDC's Advisory Committee on Immunization Practices will also discuss updates on additional doses in immune compromised individuals.

Israel has already started administering a third booster shot to people aged 60 and above after the country's health ministry reported a decrease in the effectiveness of the Pfizer Inc vaccine in preventing infections and symptomatic illness.

Last month, top U.S. infectious disease expert Anthony Fauci said Americans who are immune compromised may end up needing COVID-19 vaccine booster shots.

https://www.streetinsider.com/FDA/U.S.+CDC+advisers+to+review+data+on+COVID-19+vaccine+boosters/18791744.html

SVB Leerink Says 'We Were Wrong,' Slashes Bluebird Bio Price Target

 

  • After the FDA placed a clinical hold on Bluebird Bio Inc's (NASDAQ:BLUE) cerebral adrenoleukodystrophy gene therapy, SVB Leerink downgraded the stock to Market Perform from Outperform.
  • Analyst Mani Foroohar also slashed the price target to $20, down from $64.
  • In a note partially titled "We Were Wrong," Foroohar says the specifics of the safety event may not have read across to LentiGlobin in sickle cell disease and beta-thalassemia, "it does reflect an ongoing overhang of future headline risk." 
  • At the same time, the company's decision to close EU commercial operations and focus on the U.S. market raises questions on commercial execution, Foroohar tells investors.