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Pfizer’s COVID-19 vaccine trial reports no major safety issues

A health worker injects a person during clinical trials for a COVID-19 vaccine at the Research Centers of America in Hollywood, Florida on Sept 9, 2020. (PHOTO / BLOOMBERG)

WASHINGTON / MEXICO CITY / RIO DE JANEIRO / MONTREAL / DUBLIN / HARARE / PARIS / OTTAWA / MADRID / ATHENS / PRAGUE / KIEV – Researchers monitoring Pfizer Inc’s giant trial of an experimental COVID-19 vaccine have reported no safety problems even after more than 12,000 people received their second of two doses.

Pfizer said participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study. The trial compares two shots of the vaccine Pfizer is co-developing with Germany’s BioNTech SE to two doses of a placebo. 

“So far there has been no safety signal reported,” said Mikael Dolsten, Pfizer’s chief scientific officer, in an online meeting with investors. The trial, now targeted at enrolling 44,000 people, has reached its initial goal of 30,000 subjects, Pfizer executives said. The drugmakers have expanded the trial to to allow inclusion of teenagers and people with certain medical conditions, like HIV.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo.

Pfizer expects it will likely have results on whether the vaccine works in October.

AstraZeneca vaccine trial

AstraZeneca Plc and the University of Oxford have restarted testing an experimental COVID-19 vaccine in South Africa, according to a researcher overseeing the trial, but tests remain on hold in the US after studies were halted due to concerns about a participant who became ill.

The trial in South Africa resumed Tuesday, according to Shabir Madhi, a professor at the University of the Witwatersrand who is leading the study. The move follows a recommendation in the UK to resume tests.

The top US Food and Drug Administration official on Tuesday confirmed AstraZeneca Plc’s US vaccine trial is on hold, saying the agency is planning to do “very significant work” with the company.

READ MORE: AstraZeneca resumes UK trials of COVID-19 vaccine

J&J trial

Some volunteers have quit Johnson & Johnson’s (J&J) COVID-19 vaccine trial in Spain after news of side effects in a participant in AstraZeneca’s trial, the Spanish program’s lead investigator told Reuters on Tuesday.

The investigator, Alberto Borobia, said there were enough reserve volunteers for the trial to continue as normal. He did not say how many people had dropped out.

J&J’s Belgian Janssen unit began Phase II trials of its COVID-19 vaccine on 190 people in Spain on Monday with those tests due to conclude on Sept 22.

Trials are also being carried out in the Netherlands and Germany, taking the total number of participants in all three countries to 550. 

WHO

Less than 10 percent of global COVID-19 cases and less than 0.2 percent of deaths involved people under the age of 20, but more research is still needed on the risk of severe disease and death among children and adolescents, the head of the World Health Organization (WHO) said on Tuesday.

“We know that this virus can kill children, but that children tend to have a milder infection and there are very few severe cases and deaths from COVID-19 among children and adolescents,” said WHO Director-General Tedros Adhanom Ghebreyesus at a press briefing on Tuesday.

hough children have largely been spared many of the most severe health effects of the virus, Tedros warned that they have suffered in other ways. In many countries, for example, essential nutrition and immunization services have been disrupted, and millions of children have missed out on months of schooling.

As schools begin to reopen in many countries, the WHO chief called on governments, families and everyone in the communities to keep children safe at school with the right combination of measures. 

ICAO

A UN-led aviation task force aims to make a recommendation by late October on the use of COVID-19 testing to reduce long quarantine requirements that have decimated air travel, two sources said, following a meeting of the group on Tuesday.

Airlines and airports have asked the task force to recommend countries accept a negative polymerase chain reaction (PCR) test from passengers within 48 hours of traveling from countries with high COVID-19 infection rates as an alternative to 14-day quarantines.

The International Civil Aviation Organization-led CART task force plans to make a non-binding recommendation for countries on the use of testing at an October 29 meeting, although such efforts could be delayed, the sources said. It’s not yet clear what recommendation would be made over testing.

Algeria 

Algeria reported 238 new COVID-19 cases on Tuesday,  the lowest daily infections since June 29, bringing the tally to 48,734.

The death toll rose by 12 to 1,632 while the number of recoveries increased by 154 to 34,358, the Ministry of Health said in a statement. 

Brazil

Brazil on Tuesday registered 1,113 additional coronavirus deaths, the health ministry said, the highest number since Sept 2.

Deaths now total 133,119. Cases rose by 36,653 to 4,382,263.

Also on Tuesday, Brazil’s health regulator Anvisa authorized AstraZeneca to test its COVID-19 vaccine on an additional 5,000 volunteers in the country for clinical Phase III trials, the Sao Paulo university coordinating the test said.

Canada

Canada and the United States are expected to extend a ban on non-essential ground travel between the two countries for another 30 days, CTV reported on Tuesday.

This is the sixth extension of the ban since the outbreak of the COVID-19 pandemic. The ban, first imposed in March and has been renewed every month since then, is set to expire on Sept 21.

Canada has so far reported 138,010 cases of COVID-19 and 9,179 related deaths.

Health Minister Patty Hajdu said Tuesday she could not rule out another full lockdown if needed amid a surge in new COVID-19 cases, but added that the government was significantly more prepared to manage the virus than during the first wave.

Hajdu said Canada has made “significant improvements” in the healthcare system, and is better prepared with equipment and supplies than it was during the first wave in the spring. 

Chile

The Chilean government said Tuesday health inspections will be stepped up on social distancing measures during national holiday celebrations on Sept 18-20 to contain the spread of COVID-19.

“On pandemic issues, the health authorities have no restrictions,” and inspectors will be able to enter private homes during the holiday and fine violators of the ban on large gatherings, Interior Minister Victor Perez said at a press conference.

Residents in towns with dwindling cases will be granted a six-hour exit permit and be able to entertain a maximum of five guests at home or meet 10 others outdoors. On the other hand, people in towns under lockdown will not be able to leave their homes or invite visitors.

Chile has so far reported a total of 437,983 COVID-19 cases with 12,040 deaths.

Czech Republic

The Czech Republic’s daily count of new coronavirus cases rose to 1,677 on Tuesday, the highest on record, as the country has been struggling with the resurgent pandemic.

The overall number of confirmed cases rose to 38,896 as of the end of Tuesday, data from the Health Ministry showed on Wednesday.

Egypt

Egypt reported 163 COVID-19 infections and 18 more deaths in the past 24 hours, taking the nationwide tally to 101,340 and the death toll to 5,679, the Health Ministry said Tuesday.

The number of recoveries rose by 776 to 85,745, according to the ministry.

Ethiopia

Ethiopia’s Ministry of Health said Tuesday that the number of confirmed COVID-19 cases has risen to 65, 486 after 700 new cases were reported.

Another 13 deaths were reported, raising the death toll to 1,035, according to the minstry.

The total recoveries increased by 655 to some 25,988, the ministry said.

France

France’s health authorities on Tuesday reported 7,852 newly confirmed COVID-19 cases in the past 24 hours, rising from 6,158 new infections on Monday.

In a daily website update, the French health ministry also reported the number of arrivals in hospital for COVID-19 over the last seven days had risen to 2,713.

The number of people in France who have died from COVID-19 infections rose by 37 to 30,999. The cumulative number of cases now totals 395,104.

There were now 866 clusters under investigation, up 68 in the past 24 hours.

ALSO READ: EU countries pilot tech to link national COVID-19 tracing apps

Germany

The number of confirmed coronavirus cases in Germany increased by 1,901 to 263,663, data from the Robert Koch Institute (RKI) for infectious diseasesshowed on Wednesday.

The reported death toll rose by six to 9,368, the tally showed.

Greece

Greek authorities on Tuesday tightened restrictions to stem the spread of the coronavirus in the greater Athens area, saying the pandemic was showing “worrying signs of resilience”.

Health authorities reported 310 new confirmed COVID-19 infections on Tuesday and three deaths, bringing the total number since the first coronavirus case was detected on Feb 25 to 13,730 and the death toll to 313.

“The prefecture of Attica is now between a moderate to high epidemiological risk. There is an increase in the occupancy of intensive care beds,” Deputy Civil Protection Minister Nikos Hardalias told reporters.

Under the new restrictions, the operation of live music establishments will be suspended for 14 days and mask-wearing will be made mandatory in all closed work spaces. Masks will also be required in open air spaces in the greater Athens area when the rule of a minimum 1.5 meters of social distancing cannot be observed.

In restaurants there will be a maximum limit of six people seated per table while cinemas and theaters will be allowed to seat only at 60 percent capacity. Open air produce markets will be allowed to operate at 50 percent capacity

Ireland

Irish government ministers dropped plans to restrict their movements on Tuesday evening after Health Minister Stephen Donnelly tested negative for COVID-19, a government spokeswoman said.

The lower house of parliament had been suspended earlier on Tuesday when the speaker heard the Cabinet was self-isolating after Donnelly was advised by his doctor to take a test. The prime minister later intervened to reopen parliament.

The news came hours after Donnelly helped to unveil a new five-level system of COVID-19 restrictions under which the reopening of bars in Dublin and the relaxation of international travel restrictions were delayed due to a rise in cases. In addition, Dubliners shouldn’t have visitors from more than one home come to their houses.

Ireland reported 357 new cases of COVID-19 on Tuesday, the highest daily figure since mid-May, taking the tally to 31,549.

A total of 1,787 people have died of COVID-19 in Ireland since the start of the pandemic.

Libya

Three chartered planes of COVID-19 health supplies procured by the World Health Organization (WHO) has reached Libya, the organization said on Tuesday.

“The shipments included gloves, masks, N95 masks, face shields, gowns, goggles, oxygen concentrators, thermometers and coveralls to enhance COVID-19 response in the country. The supplies will be distributed in close cooperation with health authorities across the country,” the WHO said in a statement.

Libya has so far reported 24,144 confirmed COVID-19 cases, including 13,252 recoveries and 354 fatalities, according to the National Center for Disease Control.

Mexico

Mexico reported 4,771 newly confirmed cases of coronavirus infection and 629 additional fatalities on Tuesday, bringing its totals to 676,487 infections and 71,678 deaths, according to updated Health Ministry data.

The government has said the real number of infected people is likely to be significantly higher than the confirmed cases.

Morocco

Morocco registered 2,121 new COVID-19 cases on Tuesday, taking the tally to 90,324, the health ministry said in a statement.

Thirty-four additional deaths were reported, pushing the death toll to 1,648, while the number of recoveries rose by 2,077 to 71,047.

Netherlands

A total of 8,265 new coronavirus cases were confirmed in the Netherlands in the past week, up from the 5,427 cases reported in the seven days before that, the RIVM Dutch National Institute for Public Health and the Environment said on Tuesday. 

In the same period, 27 confirmed COVID-19 patients died.

Tunisia

More than 2 million students returned to schools in Tunisia on Tuesday after six months due to the spread of COVID-19.

In certain regions, the start of the school year has been postponed for a week due to the epidemic situation.

Tunisia has reported 7,382 confirmed cases, including 2,175 recoveries and 117 deaths, according to the latest epidemiological report released by the Ministry of Health.

Uganda

Uganda’s Ministry of Health announced on Tuesday that 145 new COVID-19 cases were recorded, bringing the total number of infections to 5,123.

Uganda has recorded a total of 2,333 recoveries and 58 deaths, according to the ministry.

UK

Britain’s testing system for COVID-19 was creaking on Tuesday as a bottleneck prevented people including medics from getting a test, with the government saying it may take weeks to resolve the problem.

Health Minister Matt Hancock said the government was working hard to fix what he said were “operational challenges” in the testing system caused by a surge in demand and that it may take weeks to resolve the shortages.

Meanwhile, the government closed a coronavirus testing facility so the site can be made available to handle customs checks after the UK leaves the European Union’s single market and customs union.

The UK recorded 27 additional deaths and 3,105 positive cases of COVID-19 on Tuesday, official statistics showed.

The additional deaths pushed the toll of those who have died within 28 days of testing positive to 41,664, one of the highest tolls in the world. The tally of infections stood at 374,228.

Ukraine

Ukraine registered a record 76 deaths related to the new coronavirus in the past 24 hours, the national security council said on Wednesday, up from a record of 72 deaths registered last week.

The council said 162,660 cases were registered in Ukraine as of Wednesday, with 3,340 deaths and 72,324 people recovered.

US

US President Donald Trump said Tuesday a vaccine against the deadly coronavirus could be three or four weeks away, underscoring predictions made by US public health officials and Pfizer Inc earlier this month.

Trump, speaking at a town hall hosted by ABC News in Philadelphia, defended his handling of the coronavirus crisis, and said a vaccine could be ready for distribution before the US presidential election on Nov. 3.

Meanwhile, US House of Representatives Speaker Nancy Pelosi said Democrats were open to delaying an October recess to get a deal with Republicans on a new coronavirus aid bill, as the White House signaled that a US$1.5 trillion proposal unveiled by moderates deserved consideration.

The US has so far reported more than 6.6 million COVID-19 cases and more than 195,000 deaths, according to a tally by Johns Hopkins University.

The coronavirus is disproportionately killing minority children in the US, especially those with other underlying health conditions, according to a federal report that shows how devastation from COVID-19 among Black and Hispanic adults has carried down to their offspring.

Of around 190,000 deaths attributed to COVID-19 in the US, 121 of those who died by July 31 were under the age of 21, according to the US Centers for Disease Control and Prevention. Three out of four were of Hispanic, Black, American Indian or Alaskan descent, the agency said in its Morbidity and Mortality Weekly Report.

Zimbabwe

Zimbabwe on Tuesday lifted a ban on inter-city travel as the government gradually reopens the economy by easing COVID-19 restrictions.

The cabinet approved the “resumption of inter-city travel to facilitate the smooth movement of examination candidates, citizens and visitors,” Information minister Monica Mutsvangwa told reporters.

The central registry would be reopened, Mutsvangwa said, to allow citizens to access births and death certificates and passports while authorities would also start to issue work permits and visas.

Zimbabwe has so far reported 7,576 confirmed cases and 224 deaths, according to a tally by Johns Hopkins University.

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