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Monday, July 19, 2021

Full Pfizer Vaccine Approval Possible by End of Summer: NIH Head

 Full approval of Covid-19 vaccine could happen by the end of the summer, NIH’s Francis Collins says at a Washington Post event.

  • He was responding to a question of why full authorization takes so long as January 2022 was set as the target date for a full approval of Pfizer’s Covid-19 vaccine
  • “I think most of us expect they’ll get there sooner than that,” maybe “by the end of the summer”

Brazil authorizes trials with 3rd dose of AstraZeneca COVID vaccine

 Brazil's health regulator Anvisa said on Monday that it has approved trials with a third dose of the AstraZeneca vaccine against COVID-19.

Anvisa said a third dose of the vaccine would be administered to 10,000 volunteers between 11 and 13 months after the second shot.

https://news.trust.org/item/20210719110447-b7df6/

Britain says most children will not be given COVID jabs

 Britain said on Monday it has decided against giving mass COVID-19 vaccinations to all children and they would only be offered in certain situations such as when young people have underlying health conditions.

Compared with adults, children are much less likely to develop severe illness following infection with the coronavirus. But the majority of British parents in a survey this month said they favoured giving their children a vaccine if offered it.

Children with severe neurodisabilities, Down's Syndrome, immunosuppression and profound and multiple learning disabilities will be eligible for the vaccine in new guidance from the Joint Committee on Vaccination and Immunisation (JCVI).

"We will be offering even more vulnerable people the protection that a vaccine brings and we will all be safer as a result," vaccine minister Nadhim Zahawi told parliament.

The government said fewer than 30 children with the virus died in the United Kingdom up to March this year.

Young people within three months of their 18th birthday will also be part of the vaccination programme "to allow a lead-in time", said Anthony Harnden, Deputy Chair of the JCVI.

Britain's decision is at odds with those taken in countries such as the United States where children over the age of 12 are being vaccinated.

https://finance.yahoo.com/news/1-britain-says-most-children-161309396.html

Cuba, Gripped by Unrest, Battles Highest COVID Caseload in Americas

  Cuba, which kept coronavirus infections low last year, now has the highest rate of contagion per capita in Latin America. That has strained its healthcare sector and helped stoke rare protests that have roiled the Communist-run island.

The Caribbean nation of 11 million people reported nearly 4,000 confirmed cases per million residents over the last week, nine times more than the world average and more than any other country in the Americas for its size.

The outbreak, fueled by the arrival of the more contagious Delta variant first identified in India, has pushed hospitals at the virus epicenter in the province of Matanzas to the brink. State media has shown rare images of patients in beds in corridors and doctors complaining of a lack of oxygen, ventilators and medicines.

Cuba's handling of the pandemic was one of the issues that propelled thousands to take to the streets https://www.reuters.com/world/americas/street-protests-break-out-cuba-2021-07-11 nationwide last Sunday in unprecedented anti-government demonstrations in a country where public spaces are tightly controlled. Demonstrators also protested shortages of food and medicines https://www.reuters.com/world/americas/cubans-turn-herbal-remedies-barter-amid-medicine-scarcity-2021-04-20 and curbs on civil liberties.

Cuba is not alone in struggling under new waves of the pandemic. But the political implications of such a crisis are greater in a country where healthcare is considered one of the pillars of legitimacy of its "revolutionary" one-party system.

Moreover the outbreak and subsequent lockdown and reduction in numbers of flights has taxed an already bankrupt economy where many work in tourism and others rely on travelers to bring in remittances and goods including medicine.

"The government has consistently made the case that one of the main accomplishments of the revolution is its world-class medical sector," said Cuban American historian Daniel Rodriguez, author of a book on medical politics in post-independence Havana.

Rodriguez said the exacerbation of food and medicine shortages over the past year due to the pandemic-related economic crisis had already broken Cuba's social pact.

"When the pandemic began spiraling out of control a couple of weeks ago, it appeared increasingly the revolutionary government was no longer able to protect Cuban lives, and the result was an extraordinary repudiation of the revolution itself."

'NOT EVEN MEDICINE'

Cuba's government has blamed the demonstrations on U.S.-financed "counter-revolutionaries" exploiting hardships caused by decades-old U.S. sanctions tightened during the pandemic. Several countries and non-government organizations including Oxfam called on Washington to lift sanctions this week.

On Saturday, authorities organized pro-government rallies across the island attended by thousands.

But many Cubans have aimed their anger at their own government's handling of the economy and the pandemic.

"We are hungry, there's nothing at the moment, not even medicine," said Aylín Sardiña, 33, at a protest in Havana.

Some critics complained that the authorities appeared to have ample transport to deploy security forces to quell protests and bus state workers to rallies, while lacking ambulances.

To be sure, Cuba has had some pandemic successes, notably the development https://www.reuters.com/article/us-health-coronavirus-vaccine-cuba-focus-idINKBN27S1OX of five vaccine candidates, two of which have proven to have efficacy of more than 90%, https://www.reuters.com/business/healthcare-pharmaceuticals/cuba-says-second-covid-vaccine-soberana-2-boasts-912-efficacy-2021-07-09according to preliminary Cuban data.

Thanks to one of the highest numbers of doctors per capita rates in the world, it was also able to send its "white coat army" https://www.reuters.com/article/health-coronavirus-cuba-doctors-feature-idINKBN2651NV to help other countries, and lately to reinforce hospitals in Matanzas.

Moreover cumulative cases per capita are still below the global average, while deaths per capita, though rising, are still just a third of the global average, a fact Cuba credits to its experimental treatments and its free, universal healthcare.

However, with cases now rising fast, a deepening of Cuba's economic crisis has prevented officials from imposing stricter lockdowns with many Cubans having to stand in lines for hours to get scarce goods.

And so far only some two million people - less than a fifth of the population - are fully vaccinated.

Brazil-based Cuban virologist Amilcar Perez Riverol said that premature triumphal statements from state media about the Cuban vaccine candidates and rallies like Saturday's may have also led to people lowering their guard, creating a breeding ground for cases to soar.

The country has an ambitious aims to have fully vaccinated 70% of the population by September. But Perez Riverol warned that in the next few weeks COVID-19 deaths would likely continue to rise as they lagged the surge in cases.

"You go out onto the street to buy food and someone says to you: do you know who else died?" said Libia Ortega, 44, a worker in a private cafeteria in Matanzas city closed due to the pandemic and shortages of products.

"The doctors are making a big effort to save lives every day but medicine and supplies are lacking."

https://www.usnews.com/news/world/articles/2021-07-19/cuba-gripped-by-unrest-battles-highest-covid-caseload-in-the-americas

Virus surge fears, UK leader’s quarantine, mar ‘Freedom Day’

 Corks popped, beats boomed out and giddy revelers rushed onto dancefloors when England’s nightclubs reopened Monday as the country lifted most remaining coronavirus restrictions after more than a year of lockdowns, mask mandates and other pandemic-related curbs on freedom.

For clubbers and nightclub owners, the moment lived up to its media-given moniker, “Freedom Day.” But the big step out of lockdown was met with nervousness by many Britons and concern from scientists, who say the U.K. is entering uncharted waters by opening up when confirmed cases are not falling but soaring.

As of Monday, face masks were no longer legally required in England, work-from-home guidance ended and, with social distancing rules shelved, no limits existed on the number of people attending theater performances or big events.

Nightclubs were allowed to open for the first time in almost 18 months, and from London to Liverpool, thousands of people danced the night away at “Freedom Day” parties starting at midnight.

“I’m absolutely ecstatic,” clubgoer Lorna Feeney said at Bar Fibre in the northern England city of Leeds. “That’s my life, my soul — I love dancing.”

At The Piano Works in London, patrons packed the area around the cordoned-off dance floor on Sunday as a host led a countdown to midnight.

Once a ceremonial ribbon was cut, the crowd ran toward the dance floor as confetti canons went off and a disco ball spun above. Soon, unmasked clubgoers dancing to a live band’s rendition of Whitney Houston’s “I Wanna Dance With Somebody” filled the floor.

One of the people attending The Piano Works party, Mark Troy, called the return of nightclubs “a most joyous occasion.”

But while entertainment businesses and ravers are jubilant, many others are deeply worried about scrapping restrictions at a time when COVID-19 cases are on a rapid upswing because of the highly infectious delta variant first identified in India. Cases topped 50,000 per day last week for the first time since January. Deaths remain far lower than in the winter thanks to vaccines, but have risen from less than 10 a day in June to about 40 a day in the past week.

Prime Minister Boris Johnson, who has dialed down talk of freedom in recent weeks, urged the public to exercise “prudence and respect for other people and the risks that the disease continues to present.”

In a reminder of how volatile the situation is, the prime minister was spending “Freedom Day” in quarantine. Johnson and Treasury chief Rishi Sunak are both self-isolating for 10 days after contact with Health Secretary Sajid Javid, who tested positive for COVID-19 on Saturday.

Johnson initially said he would take daily tests instead of self-isolating — an option not offered to most people — but U-turned amid public outrage.

The prime minister is among hundreds of thousands of Britons who have been told to quarantine because they have been near someone who tested positive. The situation is causing staff shortages for businesses including restaurants, car manufacturers and public transport.

Globally, the World Health Organization says cases and deaths are climbing after a period of decline, spurred by the delta variant. Like the U.K., Israel and the Netherlands both opened up widely after vaccinating most of their people, but had to reimpose some restrictions after new infection surges. The Dutch prime minister admitted that lifting restrictions too early “was a mistake.”

In the U.S., many areas abandoned face coverings when the Centers for Disease Control and Prevention said fully vaccinated people didn’t need to wear them in most settings. Some states and cities are now trying to decide what to do as cases rise again.

British officials have repeatedly expressed confidence that the U.K.’s vaccine rollout — 68.3% of adults, or just over half of the total population, has received two doses — will keep the threat to public health at bay. But leading international scientists described England’s move as a threat to the whole world, and 1,200 scientists backed a letter to British medical journal The Lancet criticizing the Conservative government’s decision.

“I can’t think of any realistic good scenario to come out of this strategy, I’m afraid,” said Julian Tang, a clinical virologist at the University of Leicester. “I think it’s really a degree of how bad it’s going to be.”

Tang said nightclubs in particular are potent spreading grounds, because they increase close physical contact among a core customer base — people 18 to 25 — that hasn’t yet been fully vaccinated.

“That’s the perfect mixing vessel for the virus to spread and to even generate new variants,” he said.

The government wants nightclubs and other crowded venues to check whether customers have been vaccinated, have a negative test result or have recovered from the disease.

There is no legal requirement for them to do so, however, and most say they won’t. Michael Kill, chief executive of the Night Time Industries Association, said many owners accuse the government of “passing the buck” to businesses.

“Either mandate it or don’t mandate it,” Kill said. “This is putting an inordinate amount of pressure on us.”

Johnson’s decision to scrap the legal requirement for face masks in indoor public spaces — while recommending people keep them on — has also sowed confusion.

Some retailers said they would encourage customers to keep their masks on, and London Mayor Sadiq Khan said they remain mandatory on the capital’s subways and buses — though police can no longer be called in to enforce the rule.

Khan said Monday that more than 90% of passengers appeared to be wearing masks, “and what I think that shows is that people are carrying on their great habits.”

But many believe implementing such policies will be tricky without legal backing.

Psychologist Robert West, who sits on a science panel that advises the government, said telling people to be careful without giving them thorough knowledge of risks was “like putting someone out on the road without having taught them to drive.”

The end of restrictions in England is a critical moment in Britain’s handling of the pandemic, which has killed more than 128,000 people nationwide, the highest death toll in Europe after Russia. Other parts of the U.K. — Scotland, Wales and Northern Ireland — are taking slightly more cautious steps out of lockdown and keeping mask requirements for now.

At London’s Egg nightclub, clubber Alex Clark acknowledged feeling “a bit of apprehension and uncertainty.”

Fellow clubgoer Kevin Ally felt no such qualms.

“There’s zero concern,” he said. “The only concern is why we haven’t been here for a year and a half. It’s been a very long time since we’ve been out.

“It’s good to be back, and we’re here to dance.”

https://apnews.com/article/lifestyle-europe-business-health-coronavirus-pandemic-7a18f092b6c6ebc1ecf85981a605733c

Amicus coverage resumed at Buy by BTIG

 Target $15

https://finviz.com/quote.ashx?t=FOLD

FDA OKs Sanofi fexinidazole as first all-oral treatment for sleeping sickness

 The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of age and older and weighing at least 20 kg.

Fexinidazole was developed as part of an innovative partnership between the non-profit research and development organization Drugs for Neglected Diseases initiative (DNDi), which conducted the pivotal clinical trials for this treatment, in partnership with the National Sleeping Sickness Programs of the Democratic Republic of Congo (DRC) and Central African Republic (CAR), and Sanofi.

Sleeping sickness is a parasitic disease transmitted by the bite of an infected tse-tse fly. It affects mostly populations living in remote rural areas of sub-Saharan Africa, where about 65 million people are at risk of infection. Left untreated, sleeping sickness is almost always fatal. Through Sanofi’s collaboration the number of sleeping sickness cases reported to the WHO has been reduced by ~97% between 2001 and 2020. DNDiSanofi and partners are deeply committed to ensuring access to fexinidazole in all sleeping sickness-endemic countries.

Current treatment options for the disease are effective, but burdensome for patients and health workers due to the need for infusion or injection, requiring hospitalization, especially challenging for people living in remote areas.

https://www.sanofi.com/en/media-room/press-releases/2021/2021-07-19-07-30-00-2264542