In this Sept 14, 2021, file photo, a syringe is prepared with the Pfizer COVID-19 vaccine at a clinic at the Reading Area Community College in Reading, Pennsylvania. (MATT ROURKE / AP)
RABAT / ADDIS ABABA / CAPE TOWN / NEW YORK / WASHINGTON / SANTIAGO / CARACAS / PARIS – Pfizer Inc and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in 5-11 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 authorization 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 coronavirus 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 authorized 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 Pfizer-BioNTech vaccine was authorized for the 12-15 age group roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.
In this file photo dated Nov 30, 2020, the logo of French drug maker Sanofi is pictured at the company's headquarters in Paris. (THIBAULT CAMUS / AP)Sanofi
Sanofi is dropping plans for its own mRNA-based COVID-19 vaccine because of the dominant role of the BioNTech-Pfizer alliance as well as Moderna in the fight against the pandemic, the company said on Tuesday.
The move highlights the challenges of competing in particular with pioneer BioNTech, which rose from obscurity through its alliance with pharma major Pfizer last year. The pair have delivered close to 1.5 billion doses so far, making them the western world's largest COVID-19 vaccine maker.
French healthcare group Sanofi will instead focus on efforts with British partner GlaxoSmithKline to bring another COVID-19 vaccine candidate to market based on the more conventional protein-based approach, where mass trials are ongoing.
The decision to drop clinical development of a shot based on mRNA, or messenger RNA, acquired as part of its takeover of Translate Bio, came despite positive Phase I/II study interim results announced on Tuesday where participants' blood readings showed a strong immune reaction.
But Sanofi said the read-out encouraged it only to pursue the technology as a potential vaccine against influenza and other diseases, giving up on the area of COVID-19 because of the strong market presence of the two approved mRNA shots.
"These results will clearly help inform the path forward for our mRNA development programs," said Jean-Francois Toussaint, global head of research and development at Sanofi Pasteur.
The company said it started testing an mRNA shot against seasonal influenza in humans in June and will launch follow-on clinical studies next year.
Romania
Romania reported a record number of daily infections. More than 11,000 new cases were recorded in the past 24 hours, data released Tuesday showed. Large cities including Bucharest are approaching infection rates that will lead to new restrictions, including a weekend curfew and online schooling.
The country has the second-lowest rate of vaccination in the European Union after Bulgaria. With the government struggling to boost the number of intensive-care beds available for virus patients, another 208 deaths were also reported since Monday. That brings total fatalities to more than 36,000, with the worst toll coming in the past three months.
Egypt
Egypt is now providing immediate COVID-19 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.
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.
Egypt has recorded 302,327 COVID-19 infections as of Monday, including 17,224 deaths. However, officials and experts say the real number of infections is far higher but is not reflected in government figures because of low coronavirus testing rates and the exclusion of private test results.
Africa
The number of confirmed COVID-19 cases in Africa reached 8,275,465 as of Monday afternoon, the Africa Centers for Disease Control and Prevention (Africa CDC) said.
The Africa CDC, the specialized healthcare agency of the African Union (AU), said the death toll from the pandemic across the continent stands at 209,998.
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A healthcare worker inoculates a child with a dose of the Coronavac COVID-19 vaccine at the Providencia school in Santiago, Chile on Sept 27, 2021, during the start of vaccinations in schools for children between ages 6 to 11. (ESTEBAN FELIX / AP)
Chile
Chilean authorities announced on Monday the end of a state of emergency in force since the start of the coronavirus pandemic, a sign of life returning to normal following a sharp decrease in cases in the South American nation.
The state of emergency, an extraordinary administrative measure approved by Congress early in 2020, had allowed the government to impose night-time curfews and forced quarantines on hard-hit districts amid the worst of the outbreak.
"During the last three months…the health situation …has evolved favorably, with a very significant reduction in infections, active cases, hospitalizations and deaths," President Sebastian Pinera told reporters.
The government said it would also relax restrictions on movement, liberalize limits on capacity at events and public spaces and earlier this month re-opened its borders to tourists.
The announcement comes the same day as the health officials began vaccinating children between 6 and 11 years old with China's Sinovac vaccine, which received approval for emergency in September.
Chile reported 640 new cases on Monday, with a positivity rate of about 1.08 percent in the past 24 hours.
Global tally
Coronavirus cases worldwide surpassed 232.40 million while the global death toll topped 4.75 million, according to data compiled by Johns Hopkins University.
Morocco
Morocco announced on Monday 394 new COVID-19 cases, taking the tally of infections in the North African country to 929,699.
The death toll rose to 14,199 with 32 new fatalities, while 1,081 people were in intensive care units, the Moroccan Health Ministry said.
Oxford University
The younger a child is, the less likely they are to want the coronavirus vaccine, according to a new survey of students aged nine-to-18 published in the Lancet’s EClinicalMedicine.
The OxWell School Survey 2021 found that only 36 percent of nine-year-olds were willing to take the vaccine compared to 51 percent of 13-year-olds and 78 percent of 17-year-olds.
Researchers found that those less willing to take the vaccine came from the most socioeconomically-deprived backgrounds, felt less belonging to their school communities and thought they had the virus already.
“Younger children more often defer to their parents, or primary caregivers, for decisions about health care and vaccination, but our data shows how important it is for good quality, accessible information to be provided to better enable our younger populations to understand more about the COVID-19 vaccine and its effects,” said Mina Fazel, an associate professor at the University of Oxford.
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Russia
Russia reported 852 deaths from COVID-19 in past 24 hours on Tuesday, 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.
Children play on a dusty field outside their homes in the Diepsloot Township north of Johannesburg, South Africa, Aug 26, 2021. (DENIS FARRELL / AP)
South Africa
ImmunityBio Inc, the US company backed by biotech billionaire Patrick Soon-Shiong, is planning to conduct a trial for a second COVID-19 shot in South Africa.
The new vaccine will combine the use of both ribonucleic acid, or RNA, and deoxyribonucleic acid, or DNA, as well as the adenovirus used in a an inoculation that’s already being tested, Soon-Shiong said in an interview late last week.
ImmunityBio is already running local trials of an earlier dose, known as the hAd5 T-cell vaccine, and will test it as a booster for South African healthworkers who have received Johnson & Johnson’s vaccine.
The new program’s co-ordinators “will likely start enrolling by mid-November, contingent on getting the necessary approvals” from the South African Health Products Regulatory Authority and the trial’s ethics committee, said Shabir Madhi, a vaccinologist at Johannesburg’s University of the Witwatersrand, who will be running the process.
While drugmakers around the world have produced billions of approved COVID-19 vaccines to roll out across the globe, many international pharma companies such as ImmunityBio have turned their attention to second-generation doses that could be used to fight future coronavirus variants and potentially deadly new waves.
The new vaccine is expected to bolster the production of both antibodies and T Cells that kill virus-infected cells.
“We hope that this then solves the problem of high antibodies and durable immunity,” Soon-Shiong said, adding that the trial will initially encompass the first two phases of the three-stage path to approval for emergency or general use.
At a later stage, ImmunityBio may also run a trial of a so-called subunit protein Covid-19 vaccine, Soon-Shiong said. Subunit vaccines use fragments of viruses to stimulate an immune response.
Separately, a South African official on Monday said he has written to the UK's foreign secretary to remove South Africa from UK's "red list" of travel for tourism recovery, days after another official said he will raise the matter with UK's top diplomat in the country.
David Maynier, Western Cape Province's Minister of Finance and Economic Opportunities, in a press release, said he wrote the letter on World Tourism Day about the matter, which is "deeply disappointing" and seems "manifestly unfair."
Only a British or Irish national, or a person who has residence rights in the UK are allowed to enter the UK if he or she has been in a country or territory on the red list in the last 10 days.
Maynier said this is "a significant barrier to economic recovery, specifically for the tourism sector in the Western Cape."
Tourism and hospitality sector in Western Cape, a popular tourism destination in South Africa, has been hard-hit in 2020 due to COVID-19, with an estimated loss of over 75,000 jobs, official figures showed.
In this file photo dated May 27, 2020, medical personnel adjust their personal protective equipment while working in the emergency department at NYC Health + Hospitals Metropolitan in New York. (JOHN MINCHILLO / AP / FILE)
United States
New York hospitals on Monday began firing or suspending healthcare workers for defying a state order to get the COVID-19 vaccine, and resulting staff shortages prompted some hospitals to postpone elective surgeries or curtail services.
New York City Mayor Bill de Blasio told a news conference the city's hospitals were not yet seeing a major impact from the mandate, adding he worried about other areas of the state where vaccination rates are lower.
A spokeswoman for Catholic Health, one of the largest healthcare providers in Western New York, said it had reached full compliance, counting staff members who had been vaccinated, those with exemptions and some who had been suspended without pay.
The spokeswoman, JoAnne Cavanaugh, refused to say how many workers had been suspended or granted exemptions due to medical or religious reasons.
Erie County Medical Center in Buffalo suspended elective inpatient surgeries and had stopped accepting intensive-care patients from other hospitals as it prepares to fire hundreds of unvaccinated employees, spokesman Peter Cutler said.
Cutler said the decision to curtail some operations would inconvenience patients and hurt hospital finances. Elective inpatient surgeries bring in about $1 million per week, he said.
The inoculation push comes as President Joe Biden and other state and federal political leaders ratchet up pressure on unvaccinated Americans, some of whom object to mandates on religious or health grounds.
New York's state health department issued an order last month mandating that all healthcare workers receive at least their first COVID-19 shot by Sept 27, triggering a rush by hospitals to get their employees inoculated.
Of the 43,000 employees at the New York City's 11 public hospitals, about 5,000 were not vaccinated, Mitchell Katz, head of NYC Health + Hospitals, said at the news conference with de Blasio.
Katz said 95 percent of nurses were vaccinated and all the group's facilities were "open and fully functional" on Monday.
On Saturday, New York Governor Kathy Hochul said she was considering employing the National Guard and out-of-state medical workers to fill staffing shortages, with 16 percent of the state's 450,000 hospital staff not fully vaccinated.
US President Joe Biden receives a third shot of the Pfizer COVID-19 vaccine as a booster on the White House campus Sept 27, 2021, in Washington, DC. (BRENDAN SMIALOWSKI / AFP)
Separately, US President Joe Biden rolled up his shirt sleeve and received a COVID-19 vaccine booster inoculation on Monday, hoping to provide a powerful example for Americans on the need to get the extra shot even as millions go without their first.
"Boosters are important, but the most important thing we need to do is get more people vaccinated," he said, noting that about 23 percent of people in the United States have not received a shot.
The US Centers for Disease Control and Prevention (CDC) last week backed an additional dose of the Pfizer Inc-BioNTech vaccine for Americans aged 65 and older, adults with underlying medical conditions and adults in high-risk working and institutional settings.
Senate Republican leader Mitch McConnell also received a booster shot on Monday. “All Americans should speak with their doctors and get vaccinated," he said.
Biden, 78, said his wife Jill would also get a booster shot soon.
In this file photo dated June 23, 2021, a nurse fills a syringe with a dose of the Cuban Abdala COVID-19 vaccine in Havana, Cuba. (RAMON ESPINOSA / AP)
Venezuela
Venezuela’s National Academy of Medicine on Monday expressed concern over the use of Cuba’s Abdala coronavirus vaccine due to a lack of scientific research on its safety and efficacy.
Cuba said on Saturday it had exported the three-shot vaccine for the first time, sending an initial shipment to Vietnam as part of a contract to supply five million doses to the Southeast Asian country.
The government of Venezuelan President Nicolas Maduro has so far been relying on the Russian Sputnik V and the Chinese Sinopharm vaccines, and in recent months received its first shipment of doses via the global COVAX program.
"The characteristics of the Sputnik V vaccine have been published in scientific journals and its quality has been verified in independent clinical trials … (and) the Sinopharm vaccine has been approved by the World Health Organization (WHO),” the academy said in a statement.
"Abdala has not been approved by the WHO or any international regulatory agency."
Venezuela received its first batch of 30,000 Abdala doses in June as part of clinical trials, and Cuban President Miguel Diaz-Canel on Sunday said another batch had been sent, without confirming how many vaccines were shipped.
The academy "expresses its deep concern that a product for which there is no scientific information on safety and efficacy … is being administered to Venezuelans,” the academy added.
Cuban scientists have developed three homegrown vaccines against COVID-19, all of which are waiting to receive official recognition following an evaluation by the WHO, according to the island's authorities.
