Coronavirus-hit Czechs order Regeneron antibody drug ahead of EU registration

 The Czech Republic, hard-hit by the COVID-19 pandemic, has ordered 12,000 doses of an antibody treatment made by Regeneron ahead of its registration by European authorities and will start receiving it in March, Prime Minister Andrej Babis said on Saturday.

Czech authorities are close to clearing emergency use of Regeneron's cocktail of casirivimab and imdevimab, which was authorised for emergency use in the United States in November, and was given to then U.S. president Donald Trump during his COVID-19 infection.

"We have managed to order Regeneron," Babis said on Twitter. "In total, 12,000 doses. Four thousand will come in March, the same in April and May."

The treatment is aimed at patients with mild to moderate disease who are at risk of their condition worsening.

COVID-19 antibody therapies, by Regeneron and rival Eli Lilly, are given through one-time intravenous infusion and require patients to be isolated. This complexity has led to lackluster demand for the drugs.

The Czech Republic has also granted emergency approval to Eli Lilly's therapy and ordered 500 doses.

Europe's drugs regulator EMA said on Feb. 4 it was reviewing data on both therapies for use in some patients. Italy has given emergency-use approval to the two therapies.

The Czech Republic, a country of 10.7 million, has reported 19,097 deaths. Daily infections have risen to over 10,000 in the past days, leading to the highest two-week incidence in Europe according to European Centre for Disease Prevention and Control data.

The country has administered 538,448 vaccines, which includes 204,795 people who have received both doses as of Friday, Health Ministry data showed. The figures put the Czechs below the European average, according to www.ourworldindata.org.

https://www.marketscreener.com/quote/stock/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Pharmaceuticals-Coronavirus-hit-Czechs-order-Regeneron-antibody-drug-ahead-of-EU-registr-32493912/

Russia Reports First Cases of H5N8 Bird Flu in Humans

 Russia said it found the world’s first cases of H5N8 avian influenza in humans though the virus isn’t yet spreading between people.

Authorities have sent information on the seven cases detected in workers at a poultry farm in southern Russia to the World Health Organization, Anna Popova, the country’s public-health chief, said in televised comments on Saturday.

“It is not transmitted from person to person. But only time will tell how soon future mutations will allow it to overcome this barrier,” she said. The discovery of this strain now “gives us all, the whole world, time to prepare for possible mutations and the possibility to react in a timely way and develop test systems and vaccines.”

The affected workers at the poultry farm, where an outbreak among birds was reported in December, had mild cases and have recovered, Popova said.

According to the WHO website, “Though human infections with A(H5) viruses are rare and generally occur in individuals exposed to sick or dead infected birds (or their environments), they can lead to severe illness or death in humans.” Six of 14 cases of H5N6 avian flu in humans reported since 2014 were fatal, the WHO said in a post dated Nov. 2016.

https://www.bloomberg.com/news/articles/2021-02-20/russia-reports-first-cases-of-h5n8-bird-flu-in-humans-kldnv69e

CDC urged to update guidelines on indoor air exposure to Covid

 A group of physicians and scientists is calling on the CDC to do more to address inhalation exposure to SARS-CoV-2, the virus that causes COVID-19, and protect workers in high-risk settings, including hospitals. 

In a letter dated Feb. 15 and shared with Becker's Feb. 17, 13 experts in aerosol science, occupational health and infectious disease say federal officials should strengthen measures to limit inhalation exposure to SARS-COV-2 as a cornerstone of President Joe Biden's plan for COVID-19 response and pandemic preparedness. 

The letter was sent to Jeff Zients, coordinator of the White House's COVID-19 response; CDC Director Rochelle Walensky, MD; and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the White House's health adviser.

"Our letter focuses on the importance of acknowledging the fact that aerosol transmission is playing a major role in spreading SARS-CoV-2," Kimberly Prather, PhD, one of the signatories, and infectious disease specialist and professor at UC San Diego School of Medicine, said in a news release. "We now know from evidence that infectious aerosols, produced simply by breathing and speaking, float in air for hours and can accumulate indoors in poorly ventilated spaces. 

"Our letter encourages CDC and other federal agencies to provide clear guidance on how to best protect against inhalation exposure to aerosols so we can reopen, and safely keep open, schools and businesses. This includes taking steps to test and improve ventilation and filtration to clean the air that people share in indoor spaces."

The experts said action is needed more now, given the high number COVID-19 infections and deaths, the pace of the vaccine rollout and the possibility of more transmissible variants.

They urged the CDC to update and strengthen agency guidelines to fully address transmission through inhalation exposure to small inhalable particles from infectious sources at all ranges. Respiratory protection guidelines should include all healthcare workers, not just those with direct contact with COVID-19 patients, they said. They also want federal officials to recommend the use of high-quality masks, such as N95 respirators, to protect high-risk healthcare workers, according to the New York Times. 

In an email to the newspaper, CDC officials said N95 respirators are not recommended for the general public "for reasons supported by science, comfort, costs and practicality."

For healthcare workers, the agency recommends N95 respirators to protect workers during high-risk medical procedures. 

Read the full New York Times report here. 

https://www.beckershospitalreview.com/hospital-management-administration/limiting-workers-inhalation-of-covid-19-virus-must-be-top-biden-priority-experts-tell-cdc.html

Russia approves its third COVID-19 vaccine, CoviVac

 Russia on Saturday approved a third coronavirus vaccine for domestic use, Prime Minister Mikhail Mishustin said on state TV, though large-scale clinical trials of the shot, labelled CoviVac and produced by the Chumakov Centre, have yet to begin.

Russia has already approved two COVID-19 vaccines, including the Sputnik V shot, developed by Moscow’s Gamaleya Institute, following a similar approach of granting approval before seeing any late-stage trial results.

The preemptive approvals had raised concerns among some scientists in the West, but inoculations with those first two shots began on a mass scale in Russia only after trials were concluded and showed success.

Sputnik V was approved in August and late-stage trials began in September. Mass vaccination was launched in December, after preliminary trial results showed the vaccine to be 91.4% effective.

Since then, more than two million Russians have been vaccinated with at least the first dose of Sputnik V, Health Minister Mikhail Murashko said on Feb. 10.

Rollout of a second vaccine, developed by the Vector Institute in Novosibirsk, is beginning.

“Today, Russia is the only country to have already three vaccines against COVID-19,” Prime Minister Mishustin said.

Chumakov, is known for its work with U.S. scientist Albert Sabin at the height of the Cold War, which led to the production of the widely-used polio vaccine.

DIFFERENT TYPE OF VACCINE

Unlike the Sputnik V vaccine, which uses a modified harmless cold virus that tricks the body into producing antigens to help the immune system prepare for a coronavirus infection, the CoviVac vaccine is a “whole-virion” vaccine.

This means it is made of a coronavirus that has been inactivated, or stripped of its ability to replicate.

“The vaccine we have developed... reflects the whole history of Russian, as well as global, vaccine science,” the Chumakov Centre’s director, Aidar Ishmukhametov, said on Saturday.

The advantage, according to virologist Alexander Chepurnov, cited by outlet Lenta.Ru, is that CoviVac includes all elements of the virus, creating a broader immune response that is likely to protect against any variants.

However, testing Russia’s COVID-19 shots against SARS-CoV-2 variants that have emerged in the UK, South Africa and elsewhere is in its early stages. President Vladimir Putin on Monday ordered a review of Russia’s COVID-19 vaccines to be presented by March 15 assessing their ability to protect against the new variants.

RESULTS SO FAR

Globally, one other major vaccine candidate - India’s COVAXIN by Bharat Biotech - uses the “whole-virion” approach.

India’s drug regulator has touted the shot’s ability to act against the whole body of a virus instead of just its “spike-protein” tip, potentially making it more effective in case of mutations.

The CoviVac shot is given in two doses, 14 days apart. It is transported and stored at normal fridge temperatures, of 2 to 8 degrees Celsius (35.6 to 46.4 Fahrenheit), Deputy Prime Minister Tatiana Golikova said in a government briefing in January.

The shot has already been tested for safety on 200 people aged between 18 and 60, Ishmukhametov told the state-run Vesti-24 news channel in late January.

This early-stage trial began on Sept. 21 last year, according to the state clinical trials register. It showed no side-effects, including no rise in temperature, Ishmukhametov said.

Mid-stage trials to test volunteers’ immune responses were ongoing, he said at the time.

Only a placebo-controlled, large-scale trial could ascertain effectiveness, he added. This is due to begin now that the go-ahead has been granted.

The first 120,000 doses, however, will be produced and released to the national inoculation programme in March, Mishustin said.

Then, the Chumakov Centre will produce around half a million doses per month on its platforms, Ishmukhametov said on Saturday.

Deputy Prime Minister Golikova also announced on Saturday that Russia will produce 88 million vaccine doses in the first half of this year, including 83 million Sputnik V doses.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine/russia-approves-its-third-covid-19-vaccine-covivac-idUSKBN2AK07H

Longevity gene protects brain stem cells from stress

 A gene linked to unusually long lifespans in humans protects brain stem cells from the harmful effects of stress, according to a new study by Weill Cornell Medicine investigators.

Studies of humans who live longer than 100 years have shown that many share an unusual version of a gene called Forkhead box protein O3 (FOXO3). That discovery led Dr. Jihye Paik, associate professor of pathology and laboratory medicine at Weill Cornell Medicine, and her colleagues to investigate how this gene contributes to brain health during aging.

In 2018, Dr. Paik and her team showed that mice who lack the FOXO3 gene in their brain are unable to cope with stressful conditions in the brain, which leads to the progressive death of brain cells. Their new study, published Jan. 28 in Nature Communications, reveals that FOXO3 preserves the brain's ability to regenerate by preventing stem cells from dividing until the environment will support the new cells' survival.

"Stem cells produce new brain cells, which are essential for learning and memory throughout our adult lives," said Dr. Paik, who is also a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. "If stem cells divide without control, they get depleted. The FOXO3 gene appears to do its job by stopping the stem cells from dividing until after the stress has passed."

Many challenges like inflammation, radiation or a lack of adequate nutrients can stress the brain. But Dr. Paik and her colleagues looked specifically what happens when brain stem cells are exposed to oxidative stress, which occurs when harmful types of oxygen build up in the body.

"We learned that the FOXO3 protein is directly modified by oxidative stress," she said. This modification sends the protein into the nucleus of the stem cell where it turns on stress response genes.

The resulting stress response leads to the depletion of a nutrient called s-adenosylmethionine (SAM). This nutrient is needed to help a protein called lamin form a protective envelope around the DNA in the nucleus of the stem cell.

"Without SAM, lamin can't form this strong barrier and DNA starts leaking out," she said.

The cell mistakes this DNA for a virus infection, which triggers an immune response called the type-I interferon response. This causes the stem cell to go dormant and stop producing new neurons.

"This response is actually very good for the stem cells because the outside environment is not ideal for newly born neurons," Dr. Paik explained. "If new cells were made in such stressful conditions they would be killed. It's better for stem cells to remain dormant and wait until the stress is gone to produce neurons."

The study may help explain why certain versions of the FOXO3 are linked to extraordinarily long and healthy lives—they may help people keep a good reserve of brain stem cells. It may also help explain why regular exercise, which boosts FOXO3 helps preserve mental sharpness. But Dr. Paik cautioned it is too early to know whether this new information could be used to create new therapies for brain diseases.

"It could be a double-edged sword," Dr. Paik explained. "Over activating FOXO3 could be very harmful. We don't want to keep this on all the time."

To better understand the processes involved, she and her colleagues will continue to study how FOXO3 is regulated and whether briefly turning it on or off would be beneficial for health.

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Explore further

Brain enzyme found to activate dormant neural stem cells, providing insight into neurodevelopmental disorders

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More information: Inah Hwang et al. Cellular stress signaling activates type-I IFN response through FOXO3-regulated lamin posttranslational modification, Nature Communications (2021). DOI: 10.1038/s41467-020-20839-0

https://medicalxpress.com/news/2021-02-reveals-longevity-gene-brain-stem.html

Long Islanders with comorbidities now eligible for coronavirus vaccine

 Long Islanders with certain underlying health conditions will begin getting vaccinated against the coronavirus at state-run facilities Monday.

Appointments are limited, but the state's "Am I Eligible" screening tool updates availability on a rolling basis.

People who have cancer, obesity, heart and neurological conditions, those who are pregnant and others are now eligible for the vaccine. The two state-run sites accepting appointments are at Jones Beach and Stony Brook University Hospital.

Those who want to sign up for an appointment must submit proof of their condition from a doctor's letter, medical evidence of a comorbidity or signed certification.

"The last thing is something called a signed certificate where you basically attest to the fact that you have one of these comorbidities, and you bring that to the vaccination centers with the other requirements," says Dr. Hugh Cassiere, of North Shore University Hospital. "You need to prove that you either work in New York state or you live in New York state with a valid ID."

As of now, there are no appointments at any of the state-run vaccination sites in New York City or on Long Island until mid-April. If you are in the underlying eligibility category, you can only get it at state sites like Jones Beach and Stony Brook.

State officials tell News 12 that the federal government added people with comorbidities to the 65 and older category without giving more vaccines to the state.

https://longisland.news12.com/long-islanders-with-comorbidities-now-eligible-for-coronavirus-vaccine

You'll soon be able to get a COVID-19 vaccine at a NYC Costco near you

 Vaccine distribution efforts will be getting some much-needed help from Wholesale giant Costco. The retailer just announced that it is gearing up to offer shots to folks in five states, including New York, plus Puerto Rico, "as soon as they are available."

"Costco is firmly committed to helping protect the health and safety of our members and employees, and to serving our communities," the company said in an official statement announcing the news.

Although stores in Manhattan, Brooklyn, Queens and Staten Island are scheduled to receive doses as soon as they're accessible, Costco made it clear that being a member will not guarantee anyone a shot. With only a limited number of doses available, the stores will follow each state's eligibility guidelines when working through distribution. Those interested are being asked to visit the company's website to set up an appointment.

As for which vaccine you'll be able to get, expect Costco to receive a batch of Moderna shots.

Just a few days ago, the city released some interesting data on the rollout program broken down by zip code. As the numbers make clear, there have been issues relating to the ongoing inequality in distribution that we need to face. Here's to hoping that additional sites, including the various Costco locations, will help even out the playing field. 

In case you're looking for some more information about it all, here's everything we know about the vaccine distribution process in New York at the moment.

https://www.timeout.com/newyork/news/youll-soon-be-able-to-get-a-covid-19-vaccine-at-a-nyc-costco-near-you-021921