Pfizer submits data to use vaccine in 5 to 11-year-olds – latest updates

Tuesday, September 28, 2021

Pfizer submits data for vaccine use in younger kids

Pfizer Inc and BioNTech SE have submitted initial trial data for their vaccine in 5 to11-year-olds and said they would make a formal request with US regulators for emergency use in the coming weeks.

The US Food and Drug Administration said earlier this month it would look to complete its data review for this age group as quickly as possible, likely in a matter of weeks rather than months. That could mean an authorisation of the shot for children by the end of October, sources have told Reuters.

A decision on the vaccine's use in younger children is eagerly awaited by millions of Americans as infections have soared in children to hit their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorised for 12 to 15-year-olds and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept 20.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.

Turkey administers over 108.7M vaccine jabs to date

Turkey has administered over 108.7 million jabs since the country launched an immunisation drive in January, according to official figures released.

More than 53.6 million people have received their first doses, while over 44 million are fully vaccinated, the Health Ministry said.

The data showed that some 86% of the country's adult population has received at least one dose of a two-shot vaccine.

Turkey has also given third booster shots to over 10.2 million people.

Meanwhile, the ministry also recorded 28,892 new cases and 239 related fatalities over the past day.

As many as 356,661 virus tests were done in the past 24 hours.

Earlier in the day, Turkey’s Health Minister Fahrettin Koca said the number of cases among those up to 17 years of age has doubled over the last three weeks with the re-opening of schools.

Pfizer asks Brazil to authorise booster shot

Pfizer has asked Brazil's health regulator Anvisa to approve the application of a third dose of its Comirnaty vaccine and change the package insert to include the booster option, the agency said on Tuesday.

The booster request would apply to all age groups that the vaccine is currently used for, from 12 years and up.

The study Pfizer presented on the safety of the booster dose to back up its request included the participation of Brazilian volunteers, along with volunteers from the United States and South Africa, the regulator said.

Anvisa has 30 days to study Pfizer's request.

Italy gives green light to six non-EU tourist destinations

Italy's health ministry has given the go-ahead for travel to six non-European tourist spots without the need for quarantine as precaution either on arrival or return.

Italians will be allowed to travel to the Maldives, Seychelles, Mauritius, Egypt (but only Sharm El Sheikh and Marsa Alam), Dominican Republic and Aruba on what the ministry called controlled tourist itineraries.

These popular destinations for Italians seeking winter sunshine mark an exception from other places outside the European Union, which require quarantine on return to Italy.

Everyone leaving for the selected countries must have a 'Green Pass' showing immunity, either due to vaccination or previous infection, and must also present a negative swab at least 48 hours before departure, according to the order signed by Health Minister Roberto Speranza.

Once back in Italy, people will not be required to undergo quarantine if they have presented another negative test, conducted not more than 48 hours before boarding their plane.

These so-called Covid-free tourist corridors have been set up on an experimental basis, the health ministry said.

Costa Rica mandates vaccination for all state workers

Authorities in Costa Rica said all state workers will need to be vaccinated, making it one of the first countries in Latin America to impose a vaccination mandate.

Private companies across the country will also be able to mandate vaccination for their own employees, the health ministry said in a statement. No deadline was given for when employees must comply.

Some 300,000 people work in the public sector of the Central American nation of about 5 million, whose economy depends heavily on tourism.

Approximately 40% of the population has been fully vaccinated but big gaps remain, as almost 30% of Costa Ricans have not received even a single shot.

Algeria to start Sinovac production this week

Algeria will start production of Sinovac vaccine in partnership with China on Wednesday with the aim of meeting domestic demand and exporting the surplus, the prime minister's office said.

The government has said production capacity will stand at 1 million, 2 million and 3 million doses in October, November and December respectively, before reaching 5 million doses per month from January.

The North African country has been importing vaccines, mainly Sinovac, since the coronavirus pandemic began in March 2020.

The government aims to vaccinate 70% of Algeria's 45 million people.

The vaccine will be produced in the eastern city of Constantine in partnership with state pharmaceutical products company Saidal.

Algeria also plans to begin production of Russia's Sputnik V vaccine by the end of this year.

More New York healthcare workers get vaccinated

Thousands of health care workers in New York faced with getting vaccine or losing their jobs on Monday have received at least one dose.

New York Gov. Kathy Hochul released figures showing vaccination rates rising among the state’s 450,000 hospital workers and for other health care workers. By Monday evening, 92% of nursing home staff received at least one vaccine dose. Preliminary data showed 92% of hospital staff receiving at least one dose of vaccine.

The executive order allows out-of-state doctors, nurses and other medical professionals to practice in New York, makes it easier for retirees to return to the workforce and allows doctor consults in nursing homes via telemedicine.

The order broadens the roles of emergency medical technicians, allowing basic EMTs to vaccinate and test.

Side effects after booster dose similar to shot two: US study

Most side effects after a third dose are mild or moderate, and occur at about as often as after shot two, a US study showed in a finding that was expected but nonetheless reassuring.

The report by the Centers for Disease Control and Prevention (CDC) came from more than 22,000 people who signed up to a vaccine safety smartphone app and who received a booster shot between August 12 and September 19.

During this time, third doses were authorized for people who are immunocompromised, but not the wider population.

"The frequency and type of side effects were similar to those seen after the second vaccine doses, and were mostly mild or moderate and short lived," CDC director Rochelle Walensky said at a press briefing.

Frequently reported side effects included injection site pain (71 percent of study participants), fatigue (56 percent), and headache (43 percent).

Some 28 percent reported being unable to perform normal daily activities, usually the next day.

A subset of almost 21,700 who receive d the same mRNA vaccine (Moderna or Pfizer) for all three of their doses was further analysed.

Among those who received Moderna, localised reactions, such as arm pain, were reported to be slightly more common after the third dose compared to the second.

LeBron James: ‘Not my job’ to advocate for vaccine

LeBron James drew a line in the sand over being an advocate to other players getting the vaccine, saying he doesn't think it's his place to "get involved" in decisions about "people's bodies."

James made the comments during Los Angeles Lakers media day, touching on the vaccine as well as the addition of former league MVP Russell Westbrook.

But it was vaccinations against the virus that took center stage, as James confirmed he has been fully vaccinated despite being "very skeptical about it all" before doing his research.

"I don't talk about other people and what they should do," James said.

"We're talking about individual bodies. We're not talking about something political or racism or police brutality," James went on. "I don't think I personally should get involved in what other people do for their bodies and livelihoods.

"I know what I did for me and my family. But as far as speaking for everybody and their individualities and things they want to do, that's not my job."

Bangladesh gets vaccine boost from US

Bangladesh’s sluggish vaccination drive received a welcome boost on Tuesday with the arrival of 2.5 million Pfizer-BioNTech doses.

The shipment came from the US under the global vaccine-sharing COVAX initiative, the Health Ministry said, raising Washington’s total donation to Dhaka to 3.6 million.

According to the ministry, Bangladesh has received around 50 million doses of different vaccines, both as gifts and commercial supply, and has administered more than 41 million so far.

Vaccination coverage remains quite low in the country, with around 16 million people, just about 10 percent of the population, fully vaccinated, according to latest figures.

Sanofi drops plans for mRNA vaccine

French drugmaker Sanofi said it was shelving plans for a vaccine based on messenger RNA despite positive results from early stage testing.

The Paris-based company said it will continue to develop another vaccine candidate that is already undergoing late stage human trials. That vaccine, developed jointly with Britain's GlaxoSmithKline, is based on the characteristic spike protein of the virus.

Messenger RNA vaccines use a different technology that uses genetic information from the virus to trigger an immune response. This technology is already being used in the vaccines produced by Pfizer and Moderna.

“From a public health perspective, mRNA Covid vaccines are widely available today, and starting a placebo-controlled study in countries where vaccines are available would be extremely challenging, so it does not make sense for us to further advance our mRNA Covid vaccine into Phase 3,” Sanofi said in response to questions from The Associated Press.

Sanofi recently expanded trials of its recombinant protein vaccine to test its effectiveness as a booster dose to extend immunity for people inoculated with a variety of other vaccines.

WHO chief expects collaboration on virus origins probe

The head of the World Health Organization said that he expected all countries, including China, to collaborate in the second phase of a probe into the origins of the coronavirus after an initial mission to China.

Speaking at a Geneva-based event on trade and the virus, WHO Director General Tedros Adhanom Ghebreyesus said that he hoped that the next phase of studies would begin as soon as possible.

He also repeated his support for an international treaty on pandemic preparedness and response. "The world needs a framework," he said.

Some NBA players still unvaccinated ahead of new season

The 2021-2022 NBA season, the 75th season of the association, will get underway in three weeks, but some players still remain unvaccinated, causing controversy.

A total of 90 percent of players have received at least one dose of the shot, but some players, including New Jersey Nets' superstar guard Kyrie Irving, are reportedly not vaccinated.

Players in the NBA are not currently mandated to receive the vaccine against coronavirus, but in some cities such as New York City and San Francisco, players must take the vaccine to be on the court at home.

Golden State Warriors player Andrew Wiggins previously applied for a religious exemption from receiving shots, but NBA denied his request.

"Wiggins will not be able to play in Warriors home games until he fulfills the city's vaccination requirements," NBA said.

Wiggins still defends his decision; "I'm confident in my beliefs and what I think is right, what I think is wrong. I'm just going to keep doing what I believe. Whether it's one thing or another, just going to keep doing it," he said.

Turkey to keep schools open despite high infections

Turkey will "never" close schools again despite a recent rise in infections and the government is mulling various methods to continue in-person education, Health Minister Fahrettin Koca said.

After months of online classes during the pandemic, Turkey reopened schools this month, while removing most restrictions over the summer. It also began asking for a negative PCR test or proof of vaccination from teachers and also for certain public events.

Daily deaths, which rose to around 250 this month, have fallen slightly and Turkey's vaccination rate based on population is higher than most peers.

Speaking to reporters after a cabinet meeting on Monday, Koca said a quarter of coronavirus cases detected since schools reopened were among those aged up to 17. But the priority was to continue in-person classes under all conditions, he said.

"I have said that we will keep schools open this year under any circumstances. It's not about being the last to close, they should never close," TRT Haber quoted Koca as saying.

South Africa presses WTO for vaccine patents waiver

South African President Cyril Ramaphosa asked the World Trade Organization to suspend intellectual property rights for vaccines to bridge the huge gap in vaccination rates worldwide.

India and South Africa last year brought forward the intellectual property waiver proposal before the WTO but there has been no consensus.

Proponents argue the temporary removal of IP rights will boost production in developing countries and address the dramatic inequity in access.

But there is fierce opposition from pharmaceutical giants and their host countries, which insist patents are not the main roadblocks to scaling up production and warn the move could hamper innovation.

"Passing a time-bound targeted TRIPS waiver as proposed by South Africa and India — and now supported by many countries around the world — is urgent if we are to save millions of lives."

TRIPS is a comprehensive WTO agreement on Trade-Related Aspects of Intellectual Property Rights which is used to resolve trade disputes over IP.

Pressure is mounting for an accord ahead of the 12th ministerial conference of the WTO, which runs from November 30 to December 3 in Geneva.

Egypt allows immediate vaccination amid fourth wave

Egypt is now providing immediate vaccinations at youth centers across the country without prior online registration, a step aimed at encouraging vaccinations and relieving pressure on hospitals and health units amid a fourth wave of infections.

Nearly 270 youth centers are now open for citizens to get the vaccines, the Health Ministry said, bringing the total number of vaccination sites across the country to 1,100.

The move is part of the "Together We Are Assured" campaign, launched by the Health Ministry in mid-September, that allows citizens to register and receive vaccinations immediately after complaints of a large time difference between the two steps.

Egypt said in August that it plans to vaccinate all 4.5 million of its state employees against the virus in two months.

As part of the programme, all workers in pre-university education, university employees and university students, a total of more than 5 million people, will be vaccinated before the start of the academic year in October.

So far, 11 million people in the country of more than 100 million have been given one dose of the coronavirus vaccine, while more than 5 million have been given two doses, Health Minister Hala Zayed said on Saturday.

The Health Ministry expects the peak of the fourth wave of infections in October.

Pakistan to begin vaccinating children 12 and up

Pakistan’s planning minister says the government will begin a drive to vaccinate children aged 12 or above to protect them from coronavirus.

The announcement on Tuesday by Asad Umar comes amid a steady decline in fatalities from coronavirus across the country.

Umar in a tweet said Pakistan will launch a campaign soon to vaccinate children at schools. He did not say exactly when it will begin.

Currently Pakistan is offering free jabs to teens and adults.

The latest development comes hours after Pakistan reported 41 deaths from coronavirus and 1,400 new cases in the past 24 hours.

It is the first time since July that Pakistan reported less than 1,500 single-day confirmed cases amid the fourth wave which authorities believe has subsided.

Japan to lift state of emergency at end of September: PM

Japanese Prime Minister Yoshihide Suga has said his government had decided to lift the coronavirus state of emergency in all regions at the end of the month amid a steady decline in the number of new cases.

Restrictions imposed on bars and restaurants will be eased in phases, Suga said.

Russia reports record 852 daily deaths from Covid-19

Russia has reported 852 deaths in past 24 hours, above the previous all-time high reported last week amid a spike in new cases.

The authorities reported 21,559 new coronavirus cases in past 24 hours, slightly down from 22,236 cases on Monday. 

India reports smallest rise in deaths since mid-March

India has reported 179 deaths, the smallest rise since the middle of March, taking the total to 447,373.

Infections rose by 18,795, the smallest increase since early March, lifting the total to about 33.7 million, health ministry data showed. 

France's Sanofi halts work on mRNA Covid vaccine

French pharmaceutical giant Sanofi has said it was stopping work on an mRNA vaccine despite positive test results as it lags behind rivals on producing a coronavirus shot.

The company said it would focus instead on another type of jab it is developing with British drug maker GlaxoSmithKline and which is in the final phase of human trials.

Sanofi's mRNA vaccine, the ground-breaking technology used by rivals Pfizer/BioNTech and Moderna, had positive results in phase one and two of clinical trials, the firm said.

But Sanofi said it will not take i t into the third and final phase, arguing that it would arrive too late to market with 12 billion Covid doses due to be produced by the end of the year.

Instead, the company will use the mRNA technology for vaccines against other pathogens, including the flu.

World Bank says Delta variant slowing economic growth in East Asia and Pacific

East Asia and the Pacific region's recovery has been undermined by the spread of the Covid-19 Delta variant, which is likely slowing economic growth and increasing inequality in the region, the World Bank said.

Economic activity began to slow in the second quarter of 2021, and growth forecasts have been downgraded for most countries in the region, according to the World Bank's East Asia and Pacific Fall 2021 Economic Update.

While China's economy is projected to expand by 8.5 percent, the rest of the region is forecast to grow at 2.5 percent, nearly 2 percentage points less than forecast in April 2021, the World Bank said.

"The economic recovery of developing East Asia and Pacific faces a reversal of fortune," said Manuela Ferro, World Bank Vice President for East Asia and Pacific.

"Whereas in 2020 the region contained Covid-19 while other regions of the world struggled, the rise in Covid-19 cases in 2021 has decreased growth prospects for 2021."

The report estimates most countries in the region, including Indonesia and the Philippines, can vaccinate more than 60  percent of their populations by the first half of 2022.

While that would not eliminate coronavirus infections, it would significantly reduce mortality, allowing a resumption of economic activity.

Sydney's unvaccinated warned of social isolation when lockdown ends

Sydney residents who are not vaccinated against Covid-19 risk being barred from various social activities even when they are freed from stay-at-home orders in December, New South Wales state Premier Gladys Berejkilian has warned.

Under a roadmap to exit lockdown in Australia's biggest city, unvaccinated people are already subject to delays in freedoms that will be gradually granted to inoculated citizens between October 11 and December. 1.

The two-tier system, designed to encourage more people to get vaccinated, has been criticised for both penalising vulnerable groups who have not had access to inoculations and for falling short of providing a real incentive for the vaccine hesitant.

However, Berejkilian said people who choose not to be vaccinated could be barred entry to shops, restaurants, and entertainment venues even after the state lifts all restrictions against them on December 1.

"A lot of businesses have said they will not accept anyone who is unvaccinated," Berejiklian told Seven News on Tuesday.

"Life for the unvaccinated will be very difficult indefinitely."

Pubs, cafes, gyms, and hairdressers will reopen to fully vaccinated people on October 11 in New South Wales, home to Sydney, and more restrictions will be relaxed once the state's 80 percent adult population becomes fully vaccinated, expected by the end of October.

Australia is pursuing a faster reopening through higher vaccination rates despite persistent infections, largely in its two biggest cities Sydney and Melbourne.

There are some tentative signs cases in New South Wales, the epicenter of the country's worst outbreak may be flattening.

The state reported 787 new cases on Monday, its lowest daily figure in more than a month. 

The number of people hospitalised dipped to 1,155 from 1,266 a week ago as vaccination levels in people aged over 16 topped 60 percent in the state.

Neighbouring Victoria, however, reported its biggest daily rise in infections, with 867 cases.

Australia had managed the pandemic better than many other comparable countries until the arrival of the Delta variant in June triggered a third wave of infections.

Japan seeks to lift state of emergency at end-September 

The Japanese government will seek advisers' approval to lift all emergency curbs at the end of the month as the number of new coronavirus cases falls and the strain on the medical system eases, Economy Minister Yasutoshi Nishimura has said.

If approved by a panel of government advisers, Japan as a whole would be out of a state of emergency for the first time in nearly six months.

Like many other countries, Japan had struggled to contain the spread of the highly infectious Delta variant –– including through the Summer Olympic Games –– keeping much of the country under emergency restrictions.

But new daily cases steadily declined over the past month, to 2,129 on Sunday, while the number of severe cases also fell.

About 56 percent of the population is fully vaccinated and the government has said all those who want the shot will have gotten one by November.