Russia readies for approval of second COVID-19 vaccine

Russia is preparing to approve a second vaccine against COVID-19 in late September or early October, Russian Deputy Prime Minister Tatiana Golikova said on Wednesday.

Speaking at a televised government meeting, Golikova told President Vladimir Putin that early-stage clinical trials on the vaccine, developed by the Vector virology institute in Siberia, would be completed by the end of September.

“As of today there have been no complications among those vaccinated in the first and second stages of testing,” she said.

Earlier this month Russia became the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing.

The approved vaccine, called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union, has been hailed as safe and effective by Russian authorities.

But Western experts have been sceptical about Russia’s approval of “Sputnik V”, warning against its use until all internationally approved testing and regulatory steps have been taken.

RDIF, Russia’s sovereign wealth fund, said on Wednesday the final phase of clinical trials on “Sputnik V” were beginning.

Speaking at a televised government meeting, Golikova told President Vladimir Putin that early-stage clinical trials on the vaccine, developed by the Vector virology institute in Siberia, would be completed by the end of September.

“As of today there have been no complications among those vaccinated in the first and second stages of testing,” she said.

Earlier this month Russia became the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing.

The approved vaccine, called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union, has been hailed as safe and effective by Russian authorities.

But Western experts have been sceptical about Russia’s approval of “Sputnik V”, warning against its use until all internationally approved testing and regulatory steps have been taken.

RDIF, Russia’s sovereign wealth fund, said on Wednesday the final phase of clinical trials on “Sputnik V” were beginning.

Sergei Sobyanin, the mayor of Moscow, said residents of the Russian capital could apply to take part in the trials.

These final trials, carried out on a large number of people, are normally considered essential precursors for a vaccine to receive regulatory approval.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-put/russia-readies-for-approval-of-second-covid-19-vaccine-official-idUSKBN25M22I

Pfizer says COVID-19 vaccine trial more than 50 percent enrolled

Enrollment in the 30,000-volunteer U.S. trial testing a COVID-19 vaccine from Pfizer Inc and German partner BioNTech is more than 50 percent complete, Dr. Nicholas Kitchin, a top Pfizer vaccine research and development scientist, said at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday.

Last week, the company said it had enrolled more than 11,000 volunteers in the trial.

https://www.reuters.com/article/us-health-coronavirus-pfizer-vaccine/pfizer-says-covid-19-vaccine-trial-more-than-50-percent-enrolled-idUSKBN25M26K

EU eyes initial COVID-19 vaccination for at least 40% of population

European Union nations, Britain and EU partners have agreed on a blueprint for a COVID-19 vaccination plan envisaging inoculation of at least 40% of their populations, a step that may set back the World Health Organisation’s own vaccine blueprint.

The EU target for early vaccinations is twice as high as the goal set by the WHO, which is aiming to buy vaccines initially for 20% of the world’s most vulnerable people through a global procurement scheme.

The EU estimates that the share of its population in need of initial vaccination, should a shot be developed, would be at least 40%, effectively reducing the availability of possible doses for less developed countries.

There is so far no approved COVID-19 vaccine, except one authorised in Russia before large-scale trials. The supply of the vaccines that might be successful is expected to be limited for a long period as production capacities are limited.

“Adding (up) all risk groups presently known will designate probably 40% of the population, depending on the situation and demography in countries,” said the document, adopted in late July by health experts from EU member states as well as Britain, Switzerland, Norway and Balkan countries.

The document classifies as belonging to “priority groups” over 200 million of the EU population of 450 million, including people with chronic diseases, the elderly and health workers.

Healthy people working in critical public services, such as education and public transport, are also included in the priority group although an estimate for their number is not available in the EU document.

Adding this group would raise the EU’s initial vaccination target to more than 40% of the population.

The objective of the plan is to reach herd immunity for the EU population, the document says, which could be achieved with further vaccination campaigns after the 40% goal is met.

The document gives no timeline for how fast it would expect to be able to reach its target, but outlines logistics that need to be in place for a vast inoculation programme. They range from refrigerated transport to supplies of needles and setting up vaccination locations, with the possible involvement of the army and civil protection.

EUROPE FIRST?

The European Commission, the EU executive arm, has repeatedly said it supports a global, inclusive approach on COVID-19 vaccines aimed at offering equitable access to everybody in the world.

However, it is implementing what may be seen as the equivalent of a “Europe First” strategy, in which the EU population is prioritised – effectively undermining the global approach.

The Commission has asked the 27 EU states not to buy vaccines through a purchasing scheme led by the WHO and to instead use exclusively an alternative EU plan which it deems faster and cheaper.

That approach could weaken the global procurement for which financial commitments are due by next week.

The Commission has said that it could offer financial support to the WHO scheme and donate vaccines acquired through the EU scheme, but with high vaccination targets the chances that the bloc may have surplus doses are shrinking.

Asked whether the EU and its states could donate vaccines only after the 20% inoculation target set by the WHO is met, a spokesman for the European Commission declined to comment.

The document is not binding on EU states and partners, who could target an even higher vaccination coverage for their populations, should vaccines become available.

The EU expects any available vaccine to be used with a double inoculation, further reducing the doses available to developing countries.

“A single dose vaccination is presently the most unlikely hypothesis and a booster-dosed vaccine the most likely assumption,” the document said.

https://www.reuters.com/article/us-health-coronavirus-eu-vaccination/eu-eyes-initial-covid-19-vaccination-for-at-least-40-of-population-idUSKBN25M1KW

Moderna COVID-19 vaccine appears to work as well in older adults in early study

Moderna Inc (MRNA.O) said on Wednesday its experimental COVID-19 vaccine induced immune responses in older adults similar to those in younger participants, offering hope that it will be effective in people considered to be at high risk for severe complications from the coronavirus.

The company is one of the leading contenders in the race to develop a vaccine against the virus that has killed more than 820,000 people worldwide. Its candidate, mRNA-1273, is already in late-stage human trials testing its ability to safely prevent infection.

The latest data from an early Phase I study includes an analysis from 20 additional people detailing how the vaccine performed in older adults.

The analysis looked at subjects given the 100-microgram dose being tested in the much larger Phase III trial. Moderna said the immune responses in those aged between ages 56 and 70, above age 70 and those 18 to 55-years-old were similar.

Health officials have been concerned about whether vaccine candidates would work in older people, whose immune systems typically do not respond as strongly to vaccines.

Moderna shares, which have more than tripled in value this year, rose about 6% after the data’s release.

The company has so far enrolled over 13,000 participants in its late-stage study. About 18% of the total participants are Black, Latino, Native American or Alaska Native, groups that have been particularly hard hit by the pandemic, and are often under represented in clinical trials.

Dr. Jacqueline Miller, Moderna’s head of infectious disease development, told a U.S. Centers for Disease Control and Prevention (CDC) panel the company plans to post weekly updates on enrollment of Black and Latino trial subjects on its website.

Pfizer Inc (PFE.N) told Reuters last week that 19% of the 11,000 subjects already enrolled in its vaccine trial are Black or Latino.

Miller said the demographic makeup of Moderna’s trial is a frequent topic at meetings with U.S. officials heading the White House program aimed at accelerating development of COVID-19 vaccines and treatments.

DEEP FREEZE

Companies and health officials also are working on ways to distribute COVID-19 vaccines, some of which must be shipped and stored at extremely cold temperatures.

Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, questioned Pfizer’s plans after the company said its vaccine must be stored at ultra-low temperatures for up to 6 months or in specially designed shipping containers for up to 10 days.

Once removed from the containers, the vaccine can be kept for up to a day at a temperatures between 2 and 8 degrees Celsius (36-46°F) – roughly the temperature of a normal refrigerator – or 2 hours at room temperature.

“The complexities of this plan for vaccine storage and handling will have major impact in our ability to efficiently deliver the vaccine,” Messonnier said.

Pfizer told the CDC panel it is working on making the vaccine stable at higher temperatures. Pfizer shares were down about 1.5%.

Moderna’s vaccine has to be kept at minus 20 degrees Celsius for shipping and longer-term storage of up to six months, but it can be kept at regular refrigeration temperatures for up to 10 days. The vaccine will be distributed in 10-dose vials with no preservatives, the company said.

Moderna is also working to make the vaccine stable at higher temperatures, Miller said.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.

https://www.reuters.com/article/us-health-coronavirus-cdc-moderna/moderna-covid-19-vaccine-appears-to-work-as-well-in-older-adults-in-early-study-idUSKBN25M1Y0

DOJ weighs probe of states over COVID-19 deaths in nursing homes

The U.S. Justice Department on Wednesday said it may investigate whether four states led by Democratic governors violated the civil rights of the elderly by requiring nursing homes to admit coronavirus patients, a practice which critics say led to thousands of deaths.

The department said it was seeking COVID-19 data related to nursing homes from four states: New York, New Jersey, Pennsylvania and Michigan.

“Protecting the rights of some of society’s most vulnerable members, including elderly nursing home residents, is one of our country’s most important obligations,” Eric Dreiband, assistant attorney general for the department’s Civil Rights Division, said in a statement.

Spokeswomen for Michigan Governor Gretchen Whitmer and New Jersey Governor Phil Murphy both issued statements calling the request a partisan move.

“We will review this letter and respond as appropriate. However, Americans would all be better served if the Trump administration stopped the partisan games and focused on delivering a real plan to defeat COVID-19,” Whitmer’s spokeswoman Tiffany Brown said.

A spokeswoman for Pennsylvania Governor Tom Wolf said his office was reviewing the request and looked forward to working with the Justice Department to provide whatever information was needed to fulfill it.

The elderly and people with underlying chronic health conditions are among those at highest risk for severe illness and death from COVID-19.

Since the pandemic hit the United States, nursing homes, long-term care facilities and assisted-living centers have registered some of the most lethal localized outbreaks across the country. In one grisly example, a “makeshift morgue” was discovered at a nursing facility in New Jersey, sparking a state investigation.

Two of the four targeted states, Michigan and Pennsylvania, are among the most hotly contested in the Nov. 3 presidential election.

All four states have been hit hard by the pandemic, reporting among the highest number of COVID-related cases and deaths associated with nursing homes, according to figures reported by the U.S. Centers for Medicare and Medicaid Services.

https://www.reuters.com/article/us-health-coronavirus-justice-elders/u-s-justice-department-weighs-probe-of-blue-states-over-covid-19-deaths-in-nursing-homes-idUSKBN25M2J5

CDC says testing not needed for some exposed to COVID-19, drawing fire

The U.S. Centers for Disease Control and Prevention (CDC) narrowed its guidance for who should get tested for COVID-19 this week, saying people who were exposed but are not symptomatic may not need to be tested.

That marks a reversal of the agency’s previous position recommending testing for all close contacts of people diagnosed with COVID-19, raising questions from some politicians and health experts about whether the change was based on political pressure.

U.S. government health officials said during a call with reporters on Wednesday that the guidelines should not be interpreted as “inhibiting public health.”

The goal is “appropriate testing,” not more testing for its own sake, said Brett Girior, the assistant secretary for health at the Department of Health and Human Services (HHS).

Tests of asymptomatic people conducted too early to accurately detect the virus can lead to a false sense of security and potentially help spread the virus, he said.

Girior said the new guidance was not prompted by testing shortages.

Health experts said the move could hurt contact tracing efforts to prevent virus spread.

“It’s inexplicable why this guidance suddenly changed. There is no new science that we’re aware of,” Dr. Leana Wen, former Baltimore health commissioner and visiting professor at George Washington University Milken Institute School of Public Health told CNN. “We need far more testing, not less.”

The new guidelines were a collaboration between the CDC, the Food and Drug Administration and HHS, which oversees the two agencies.

The Trump administration has been criticized for its handling of COVID-19 testing, with many states falling short of the volume needed to help contain the virus during major outbreaks. It has also been accused of interfering with the CDC on previous guidelines such as for school reopenings.

Girior said there was no political pressure from the administration behind the decision to change testing guidelines.

“This was a product produced by the scientific and medical people that was discussed extensively at the task force,” he said. The task force is led by Vice President Mike Pence.

New York Governor Andrew Cuomo was quick to challenge the assertion that politics played no role in the change.

“We need public health people who do public health and not politics, and we’re going to disregard the CDC guidance totally,” he told MSNBC.

https://www.reuters.com/article/us-health-coronavirus-cdc-testing/u-s-health-agency-says-testing-not-needed-for-some-exposed-to-covid-19-drawing-criticism-idUSKBN25M2GD

Biogen stock a big risk worth taking?

Biogen will find out in early 2021 whether it will have the largest sales opportunity for the pharmaceuticals industry in at least a decade. Meanwhile, the drug company’s stock is a worthy risk for investors who can stomach a roller-coaster ride.

At first look, Biogen seems more like a plodding drugmaker than a pending highflier: The neurology specialist boasts a market cap of about $46 billion. Second-quarter sales of $3.7 billion grew by just 2% from a year earlier. The shares trade at just 8 times this year’s adjusted earnings forecasts due to growth concerns. Generic-drugs giant Mylan launched a version of Biogen’s blockbuster multiple sclerosis drug Tecfidera earlier this month, and competition is heating up for Biogen’s spinal muscular atrophy treatment Spinraza.

Instead, the action rests entirely on the prospects for Biogen’s experimental Alzheimer’s disease treatment, aducanumab. The Food and Drug Administration will decide whether to approve the drug by March 7, though an earlier ruling is possible. The stakes for investors couldn’t be higher. A green light means years of blockbuster sales ahead, while a setback will mean a lengthy product delay and, in all likelihood, a sharp selloff.

Bears point to flaws in the aducanumab clinical data and there is evidence from the drug’s recent history to back that view: Biogen and its partner Eisai Co. terminated two late-stage studies in March 2019 after an analysis determined there was less than a 20% chance the drug would succeed in slowing study patients’ cognitive decline. Later that year, the company announced that subsequent analyses showed that one of the studies was successful and that the other had likely failed because of changes the company made to the study design halfway through the trial.

But regulators in recent years have shown more flexibility in granting approval to drugs that address previously unmet medical needs. And until Covid-19 emerged, it was hard to imagine a larger unmet need than Alzheimer’s disease.

Existing treatments don’t slow the progression of Alzheimer’s, which is eventually fatal. There are 5 million Americans currently living with the disease, according to the Alzheimer’s Association. That number is projected to increase rapidly in the years to come as the population ages. What’s more, caring for patients is dearly expensive, which assures high demand for even marginal therapeutic options.

Biogen stock, currently trading at around $275 a share, reached $500 back in 2015, when the company unveiled earlier stage aducanumab data. Back then, shares traded as high as 26 times forward earnings. In an ebullient market, shares may well drift higher before the FDA’s decision, though a return to that lofty multiple seems unrealistic.

Real growth prospects at a sane valuation are exceedingly hard to find in 2020. Opportunities like Biogen are worth stomaching some risk.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-Stock-Is-a-Big-Risk-Worth-Taking-Heard-on-the-Street-31181942/