AbbVie Gets FDA OK for Pediatric Skin Infection Drug

 AbbVie Inc. received U.S. Food and Drug Administration approval for its treatment of acute bacterial skin and skin structure infections in children and infants, the company said Friday.

The Dalvance drug is administered intravenously in a single dose. In clinical trials, the treatment was found to reduce lesion size and didn't require rescue antibacterial therapy for children 3 months and older, the company said. The treatment's safety findings in pediatric patients were also similar to those seen in adults, it said.

Such skin infections are caused by Gram-positive pathogens, such as Staphylococcus aureus and Streptococcus pyogenes, and they can be serious and life-threatening, AbbVie said.

https://www.marketscreener.com/quote/stock/ABBVIE-INC-12136589/news/AbbVie-Gets-FDA-OK-for-Pediatric-Skin-Infection-Drug-35934844/

Vietnam may approve homegrown Nano Covax vaccine for emergency use

 Vietnam is evaluating its domestically developed COVID-19 vaccine, Nano Covax, for possible approval for emergency use in the country.

The Ministry of Health and the Ministry of Science and Technology held a meeting on July 22 to review the outcomes of clinical trials of the vaccine, which is produced by Nanogen Pharmaceutical Biotechnology JSC based on recombinant DNA/protein technology.

Based on the evaluation, the vaccine may be approved for emergency use.

It went through the first phase trial from December 18, 2020, and the second phase from February 26, 2021. The third phase started on June 11, 2021.

Results from the first two trial phases showed that all volunteers developed antibodies against SARS-CoV-2.

At the meeting, a representative from Nanogen said more than 13,620 volunteers had been vaccinated with Nano Covax vaccine so far.

The third and the final phase saw participation of 13,000 volunteers with 1,004 people getting two jabs.

The company said it would continue to complete documents relating to the products and outcomes of the trials to submit to the Ministry of Health next week.

Chairman of the Advisory Council for the Registration of Circulation of Drugs and Medicinal Ingredients Le Van Truyen said the council supported the research and development of homegrown vaccines but registration dossiers for approving vaccines in emergency situations must meet scientific and legal standards.

Deputy Minister of Science and Technology Bui The Duy said under the current complex development of the pandemic, the ministry hoped health experts would evaluate outcomes of the clinical trials scientifically and create conditions to speed up research and production of the vaccine.

Deputy Minister of Health Tran Van Thuan said the ministry supported and created conditions for Nanogen as well as other domestic companies and units to research and develop vaccines with the hope that Vietnam would soon be able to produce “Made in Vietnam” vaccines to help ensure vaccine supply for coronavirus control.

Regarding licensing conditions, Thuan asked Nanogen to work with agencies to complete dossiers about the outcomes of the first and second phases of human trials and soon update results of the third phase.

Based on the outcomes of trials and the opinions of domestic and foreign experts as well as the pandemic situation and vaccine demand, the Ministry of Health will study and consider the licensing of the Nano Covax vaccine for emergency use.

Nano Covax is the most promising candidate among four domestic vaccines being developed by Vietnam. If approved, commercial production could start soon.

The other vaccines are being developed by the Institute of Vaccines and Medical Biologicals, the Vaccine and Biological Production Company No. 1, and the Center for Research and Production of Vaccines and Biologicals.

Vietnam has so far approved six vaccines for emergency use, namely Janssen, Moderna, Sputnik V, Pfizer, Sinopharm and AstraZeneca.

The Government is making efforts to secure at least 150 million vaccine doses to inoculate 70 percent of the population.

As of July 23 morning, 4,411,659 doses of the vaccines, mainly AstraZeneca, have been administered in Vietnam, with 334,560 people having received the full two doses.

https://en.vietnamplus.vn/vietnam-may-approve-homegrown-nano-covax-vaccine-for-emergency-use/205172.vnp

Chinese COVID shot may offer elderly poor protection

 A new study suggests that a Sinopharm vaccine offers poor protection from COVID-19 among the elderly, raising questions for dozens of countries that have given the Chinese company’s shots to their most vulnerable populations.

A survey of blood samples taken from 450 people in Hungary at least two weeks after their second Sinopharm dose found that 90% under 50 years old developed protective antibodies. But the percentage declined with age, and 50% of those over 80 had none.

The study by two Hungarian researchers was posted online this week but not yet reviewed by other scientists. Three outside experts said they had no problems with the methodology of the study of the vaccine developed by Sinopharm’s Beijing Institute of Biological Products.

“This is very, very worrying that these people, who are high-risk, have a poor antibody response,” said Jin Dong-yan, a Hong Kong University virologist who was not affiliated with the study.

Antibody levels are not a direct measure of how protected a person is from COVID-19, but there is growing evidence that they are a good proxy. One expert cautioned that the choice of test kits could have limited the accuracy of the measurements.

Still, the study’s findings have value and are the first public, scientific attempt to analyze the effect of the Sinopharm vaccine in the elderly, said Wang Chenguang, a former professor at Peking Union Medical College and an immunology expert.

China’s National Health Commission declined to comment on the study, saying it would only respond to studies by governments or major research institutions.

This is not the first time questions have been raised about the efficacy of the vaccine, which was given a greenlight by the World Health Organization in May and is being used in more than 50 countries, many of which seized upon it when other vaccines were tough to come by.

A spokesperson for the WHO said Wednesday that its experts “are aware of the study and continue to look at all available evidence.” The agency’s advisers raised questions months ago about whether it provided protection in people 60 and over, but when it was OK’d a WHO expert said that there was no reason to think it would work differently in the elderly.

The vaccine is one of two similar shots developed by Sinopharm. The state-owned Chinese company’s research showed that almost all the participants in final-stage clinical trials were under 60 — and its own researchers said there was insufficient evidence to say whether the vaccines work in the elderly. Overall, the Beijing Institute vaccine was found to be 78% effective.

In Hungary, concern about the shots led many to seek out private antibody tests. Eventually the capital city of Budapest offered free testing to elderly residents as part a bid to ratchet up pressure on the government to conduct its own wider survey and provide booster shots to those who need them.

After initially rebuffing calls for a government response to efficacy concerns — including from the antibody study’s authors Balazs Sarkadi and Tamas Ferenci — Prime Minster Viktor Orban finally acquiesced last week in the face of growing public anger. He announced that the government would provide its citizens with an optional third shot.

His office said, though, that all vaccines authorized by Hungary are effective.

The United Arab Emirates and Bahrain both announced in May that they, too, would offer a third dose of Sinopharm amid concerns about an insufficient antibody response. Bahrain recommended that people over 50 and some other vulnerable people receive Pfizer-BioNTech’s vaccine as their booster regardless of whether they got Sinopharm initially.

CNBG, the Sinopharm subsidiary that oversees the Beijing Institute, has said a third dose is not part of the company’s clinical guidance.

It’s not clear how many doses of the Beijing Institute Sinopharm vaccine have been exported. Overall, China exported 500 million vaccines doses in the first half of the year, and the company is one of country’s two major COVID vaccine makers, along with privately owned Sinovac.

The Global Alliance for Vaccines and Immunization recently ordered 550 million doses from the two companies for the U.N.-backed COVAX program.

Both Sinopharm vaccines are also in wide use in China, including in the elderly. The country’s National Health Commission said in April that the shots provide some protection, even though it acknowledged that early stages of clinical trials of Sinopharm’s vaccines and two others found fewer antibodies in people 60 and over.

In Budapest, Beata Englohner became concerned for her 76-year-old mother after hearing that people who had been vaccinated with Sinopharm were shown to have no antibodies.

Englohner started a Facebook group to press the government to address the issue. She is cautiously optimistic now that Hungary will offer a third dose.

“We’re very glad that we achieved our aim and that we were heard,” she said. “Though we’re a bit afraid that we’ll receive what we already got before.”

https://apnews.com/article/europe-middle-east-business-science-health-4b770731d5995e3bb49a1d8ec63febbd

Ill. sees 6X more gamma variant cases than delta so far

 Illinois has seen six times as many gamma variant cases of the coronavirus as delta variant ones, according to an analysis done by Chicago's local CBS News affiliate, though the state health department indicates that will likely soon change.

There have been more than 10,000 variant COVID-19 cases recorded so far by the Illinois Department of Public Health as of Monday, according to the outlet, with the gamma variant making up more than 2,600 of them compared to only 403 for the delta, which has been been wreaking havoc across the nation.

"The Gamma variant became established in Illinois this Spring, before the Delta variant was identified in Illinois. Many cases of Gamma variant were associated with travelers returning home from other states  tournaments, camping, etc. We saw mainly community-specific transmission," a spokesperson for the health department told The Hill on Friday.

"Through increased testing, more sequencing, and vaccination targeting hot spots, we’ve been able to contain the increase for the most part. We are now seeing Delta replacing what has been the most common strain. Alpha was replaced by Gamma, and now the rate of growth with Delta indicates that it will replace Gamma," the spokesperson added.

Centers for Disease Control and Prevention Director Rochelle Walensky said Tuesday that the delta variant made up 83 percent of all current COVID-19 cases in the U.S.

Illinois has had more than 1.4 million reported cases of the coronavirus with more than 25,000 deaths, according to data from John Hopkins University. 

“The Delta variant that we are hearing so much about doesn’t seem to be making, as of yet, as much inroads into Chicago as we would’ve otherwise expected,” Stefan Green, director of the Genomics and Microbiome Facility at Rush University Medical Center, told CBS News earlier this week.

Preliminary research has indicated that the available coronavirus vaccines are effective against variants of the virus, but vaccination rates have significantly dropped off in recent weeks.

Illinois has 50 percent of its population fully vaccinated against the coronavirus.

https://thehill.com/policy/healthcare/564173-illinois-reporting-six-times-as-many-gamma-variant-cases-than-delta-report

At least 100 US athletes unvaccinated as Olympics begin

 About 100 of the 613 U.S. athletes descending on Tokyo for the Olympics are unvaccinated, the U.S. Olympic and Paralympic Committee’s medical chief said hours before Friday night’s opening ceremony.

Medical director Jonathan Finnoff said 567 of the American athletes had filled out their health histories as they prepared for the trip, and estimated 83% had replied they were vaccinated.

“Eighty-three percent is actually a substantial number and we’re quite happy with it,” Finnoff said.

Nationally, 56.3% of Americans have received at least one dose of the vaccine, according to the Centers for Disease Control and Prevention.

The IOC has estimated around 85% of residents of the Olympic Village are vaccinated; that’s based that on what each country’s Olympic committee reports but is not an independently verified number.

The USOPC figure is more solid — based on questionnaires athletes were asked to fill out before they came to Japan. Finnoff said the committee is not differentiating its treatment of athletes based on whether they’re vaccinated.

“The best thing to do is to assume everyone’s at risk, and reduce risk by introducing COVID mitigation measures that we know work,” he said.

So far, two American athletes — beach volleyball player Taylor Crabb and Kara Eaker, an alternate on the gymnastics team — are known to have tested positive. The IOC has reported 13 positives among all athletes in Japan.

The vaccination rate was the biggest news to come out of an hourlong Q&A with USOPC leadership — a far different affair from the last pre-Olympic news conference. That one, at the Winter Olympics in Pyeongchang, was dominated by talk of the federation’s handling of sex-abuse cases in the wake of the trial of former team doctor Larry Nassar.

The USOPC leadership has almost completely turned over since then.

Susanne Lyons is the new chair, Sarah Hirshland is the new CEO and Rick Adams is the new chief of sport performance.

Part of the USOPC’s reboot involved deemphasizing the quest for medals and focusing more on athlete health and welfare. The U.S. has led the medals table at every Summer Games since 1996, the Olympics after the old Soviet team disbanded.

But Hirshland is well aware that her performance, and the team’s, will still be judged at some level on medals.

“Is the U.S. coming here hoping to win a lot of medals? You bet we are,” Hirshland said.

All expectations, however, are tempered by the reality that a COVID outbreak could turn plans upside down.

“Athletes have adjusted to being comfortable being uncomfortable,” Adams said,. “They’ve been experiencing it, and over the next 17 days, the expectation is to set expectations around things that could change.”

https://apnews.com/article/olympics-unvaccinated-us-athletes-459f78d7fd9b160de819c335300ba3db

Cytek Biosciences prices IPO

 Cytek Biosciences, Inc. (“Cytek Biosciences” or “Cytek”) (Nasdaq: CTKB), a leading cell analysis solutions company, announced today the pricing of its initial public offering of an aggregate of 16,749,330 shares of its common stock at a price to the public of $17.00 per share. The gross proceeds to Cytek from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $200 million. Cytek is offering 11,764,706 shares of common stock and the selling stockholders named in the prospectus are offering 2,799,929 shares of common stock. Cytek will not receive any proceeds from the sale of shares by the selling stockholders. In addition, Cytek has granted the underwriters a 30-day option to purchase up to an additional 2,184,695 shares of common stock solely to cover over-allotments, if any, at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the symbol "CTKB" on July 23, 2021. The offering is expected to close on July 27, 2021, subject to satisfaction of customary closing conditions.

Morgan Stanley, Goldman Sachs & Co. LLC, Piper Sandler & Co. and Cowen are acting as joint book running managers for the offering.

https://www.globenewswire.com/news-release/2021/07/23/2267811/0/en/Cytek-Biosciences-Announces-Pricing-of-Its-Initial-Public-Offering.html

New Covid testing plan will not work: UK industry body

 The government's plan to allow key industries in England to apply for named workers to be exempt from self-isolation is "undeliverable", an industry body has said.

The idea is to let staff keep working in sectors such as energy and water by introducing daily Covid testing.

But the CBI said the list would soon be "significantly challenged".

And it called for an earlier date for the relaxation of self-isolation rules under the NHS Covid app.

As things stand, the rules on self-isolation are due to be relaxed next month.

John Foster, CBI director of policy said: "If we want the economy to stay open, we need a confident but balanced plan. We should bring forward the date from 16 August when those who have been double-jabbed no longer need to self-isolate if they test negative once contacted.

"We also need a test-and-release scheme for those who have not been double-jabbed."

The government's plans allow 16 key sectors in England to deploy daily Covid testing instead of self-isolation for a limited number of essential workers.

The scheme, introduced following concerns that some sectors of the economy were suffering because too many of their workers had been told to self-isolate by the NHS Covid app, will only apply to workers who are fully vaccinated.

It covers sectors including transport, emergency services, border control, energy, digital infrastructure, waste, the water industry, essential defence outputs and local government.

The policy applies only to workers named on a list kept updated by officials - it is not a blanket exemption for all employees in a sector.

Mr Foster said the list would help some critical sectors to "keep moving".

But he added it would "rapidly become significantly challenged".

"The idea of potentially thousands of businesses emailing Whitehall officials to request approval for individuals to go to work is undeliverable, let alone undesirable," he said.

He also said the list missed out many businesses in the various supply chains that would be "crucial to the running of these key industries, so will need to be significantly expanded within days".

However, the CBI has welcomed the government's approach to tackling staff shortages in the food industry - allowing supermarket depots and food manufacturers to use a test-and-release scheme which allows a blanket exemption.

"We need mass testing - not mass self-isolation - to tackle staff shortages. That's why the government should be applauded for moving to a test-and-release scheme for the food industry to help relieve staff shortages.

"If the Daily Contact Testing scheme is deemed as a good, safe solution by the government, the next step must be to scale this up at pace."

'Laborious process'

Essential transport is one of the key sectors included in the government's list of critical key workers eligible for exemption from self-isolation.

But the body representing major ports said it deserved to be treated like parts of the food industry, with blanket exemptions.

The UK Major Ports Group (UKMPG) said its members had to go through "laborious process of producing, agreeing, and receiving official letters of approval from Government to secure exemption for named individuals only"."

"Considering UK major ports handle nearly half of all the nation's food and feed, UKMPG fails to understand why it is acceptable for one rule to be given to food hauliers and one rule for another critical pinch point in the supply chain.

"While thousands of supermarket staff have been waived through with a blanket exemption, our industry has not been afforded such a privilege."

https://www.bbc.com/news/business-57945229