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Brazil health regulator Anvisa allows Chinese COVID-19 vaccine trial
4 July 2020, 5:29 AM

Brazilian health regulator Anvisa on Friday approved clinical trials of a potential coronavirus vaccine developed by China’s Sinovac,according to an official gazette publication.

The study – first announced on June 11 – is led by Instituto Butantan, a research center funded by the state of Sao Paulo.

The agreement with Sinovac includes not only trials but also the transference of technology to produce the potential vaccine locally.

On June 29, Sao Paulo state Governor Joao Doria said 9 000 volunteers have already been registered to test the vaccine against COVID-19, the respiratory disease caused by the novel coronavirus.

Trials will be conducted by 12 research centers in six Brazilian states: Sao Paulo, Rio de Janeiro, Minas Gerais, Brasilia, Rio Grande do Sul and Parana, according to Doria.

Anvisa’s approval comes after Brazil surpassed 1.5 million confirmed cases of COVID-19, according to Health Ministry data,the second worst outbreak after the United States.

The number of deaths rose by 1 290 in the past 24 hours, bringing the total tally to 63 174, the data showed.

Mainland China reports three new coronavirus cases
4 July 2020, 4:44 AM

China on Saturday reported three new coronavirus cases in the mainland for July 3, compared with five cases a day earlier, the health authority said.

Two of the new infections were imported cases, the National Health Commission said in a statement, while the capital Beijing reported one new case.

There were no new deaths.

China also reported four new asymptomatic patients, the same as a day earlier.

As of July 3, mainland China had a total of 83 545 confirmed coronavirus cases, it said.

China’s death toll from the coronavirus remained at 4 634, unchanged since mid-May.

Gilead’s COVID-19 antiviral remdesivir gets conditional EU clearance
4 July 2020, 3:38 AM

The European Commission said on Friday it had given conditional approval for the use of antiviral remdesivir in severe COVID-19 patients following an accelerated review process, making it the region’s first authorised therapy to treat the virus.

The move comes just a week after the European Medicines Agency gave its go-ahead for the drug, produced by Gilead Sciences to be used in adults and adolescents from 12 years of age who are also suffering from pneumonia and require oxygen support.

It also comes just days after the company allocated nearly all of its supply of remdesivir to the United States over the next three months, stirring concerns about availability elsewhere.

“We will leave no stone unturned in our efforts to secure efficient treatments or vaccine against the coronavirus,” said Stella Kyriakides, EU Commissioner for Health and Food Safety, in a statement.

The Commission said on Wednesday it was in negotiations with Gilead to obtain doses of remdesivir for the 27 European Union countries.

Remdesivir is in high demand after the intravenously-administered medicine helped to shorten hospital recovery times in a clinical trial.

It is believed to be most effective in treating COVID-19 patients earlier in the course of disease than other therapies like the steroid dexamethasone.

Still, because remdesivir is given intravenously over at least a five-day period it is generally being used on patients sick enough to require hospitalisation.

The EU’s green light broadens the use of remdesivir around the world – the United States has cleared it for emergency use and it is also approved as a COVID-19 therapy in Japan, Taiwan, India, Singapore and the United Arab Emirates, Gilead said on Friday.

A conditional marketing authorisation is one of the EU regulatory mechanisms created to facilitate early access to medicines that fulfil an unmet medical need, including those for emergency situations in response to public health threats such as the current pandemic, the Commission said.

The approval is valid for one year in the bloc and can be extended or converted into an unconditional marketing authorisation if all necessary data are available on its efficacy and side effects.

The agency reviews data as they become available on a rolling basis, while development is still ongoing. The EMA’s rolling review began at the end of April.

Mexico registers 6 740 more coronavirus infections, 654 new deaths
4 July 2020, 2:53 AM

Mexico on Friday reported 6 740 new coronavirus infections, taking the country’s total to 245 251 cases, more than Italy and the ninth-highest tally worldwide, according to a Reuters count.

Mexico’s Health Ministry also reported 654 more fatalities, bringing the total to 29 843 deaths, just a few behind France which currently has the fifth-highest death toll.

Friday’s new cases were just one less than the record number reported on Thursday in Mexico.

More than two months after President Andres Manuel Lopez Obrador said Mexico had tamed the pandemic, the country has in recent weeks been posting some of the highest daily death tolls worldwide alongside Brazil and the United States.

The Health Ministry has said examinations of recent fatalities in Mexico could bump up the numbers further, especially as the country tries to revive its battered economy.

“As we’re in an active epidemic, the risk is that as we try to reopen social activities … we may have more infections and the transmission could be maintained or increase,” Deputy Health Minister Hugo Lopez-Gatell told a news conference.

Mexico’s government has said the real number of infected people is likely significantly higher than the confirmed cases.

 

Several US states post record COVID cases, curfew ordered in Miami
4 July 2020, 2:10 AM

Alabama and several other states reported record increases in coronavirus cases on Friday as Florida’s most populous county imposed a curfew ahead of the Independence Day weekend and Arkansas joined a push towards mandating mask-wearing in public.

North Carolina, South Carolina, Tennessee and Alaska all saw new daily highs in cases of COVID-19, the illness caused by the novel coronavirus, while Texas hit a new peak for hospitalisations, with one doctor calling for a “complete lockdown” in the state to get the virus under control.

The recent surge, most pronounced in southern and western states, has alarmed public health officials, who urged caution ahead of a July 4th holiday weekend to celebrate the Declaration of Independence of the United States in 1776.

North Carolina reported 951 hospitalizations and 2 099 cases, both record highs.

Bill Saffo, mayor of Wilmington, North Carolina, said many infections had been traced to large gatherings and predicted a further jump after the holiday weekend as people flouted guidelines on social distancing and masks.

“We know that the spread is going to happen. We know probably in about two weeks we’ll see a spike from the July 4th weekend,” Saffo told CNN.

Despite the jump in infections, the daily death rate in the United States has remained relatively flat, a reflection of the growing proportion of positive tests among younger, healthier people who are less prone to severe outcomes.

However, US Surgeon General Jerome Adams warned that the impact on fatalities from the recent surge, which started in mid-June, had yet to be seen. “Deaths lag at least two weeks and can lag even more,” he told “Fox & Friends” on Friday.

His remarks came hours ahead of a trip by President Donald Trump to Mount Rushmore in South Dakota where he is expected to give a speech to thousands of supporters in which he will rail against the “left wing mob” and view a fireworks display at the landmark depicting four US presidents in stone.

The visit has drawn criticism from Native Americans, who say the remote area is sacred to them, as well as health experts who discourage large congregations of people.

Trump, whose handling of the pandemic has come under harsh criticism from Democrats and some Republicans, has repeatedly sought to dismiss the jump in cases as a function of more tests and again this week predicted the virus would “disappear.”

More masks

Coronavirus cases are rising in 37 of the 50 US states including Florida which had 9 488 new cases on Friday, according to the state health department. Florida’s 10 109 cases on Thursday was a record for the state and more than any European country’s daily peak at the height of the outbreak there.

Evidence the surge is not simply due to expanded testing, the percentage of tests coming back positive in Florida has hit 16%, up from 4% a month ago, according to a Reuters analysis. The World Health Organisation says a rate over 5% is concerning.

Against that backdrop, Miami-Dade County Mayor Carlos Gimenez imposed an indefinite nightly curfew starting Friday and halted the reopenings of entertainment venues such as casinos and strip clubs.

Earlier this week, Miami-Dade and neighboring Broward County, the state’s two most populous counties, required residents to wear face coverings in public.

Arkansas Governor Asa Hutchinson on Friday authorized the state’s cities and towns to enact a “model ordinance” requiring the wearing of face coverings if they choose to do so, becoming the latest Republican to relent to pressure on the issue.

The move came a day after Texas Governor Greg Abbott ordered that face masks be worn in most public places, reversing his stance following an alarming rise in infections in the state, which on Friday marked a new high for hospitalizations at 7 652.

Owais Durrani, a resident at University Hospital in San Antonio, said nearly all the patients coming into the emergency room tested positive for COVID-19 – even those admitted for unrelated issues such as gall bladder infections.

“We, in my opinion, need to go into a complete lockdown and we’re still going to see an increase in all of those metrics for two to three weeks and then maybe we turn a corner,” he said.

 

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