Pfizer, BioNTech seek EU signoff on virus shot for younger teens

Medical Staff prepares a vial of the Pfizer/BioNTech Comirnaty vaccine against COVID-19 at a vaccination center at the Messe trade fair grounds during the third wave of the coronavirus pandemic on April 8, 2021 in Erfurt, Germany. (JENS SCHLUETER / BLOOOMBERG)

BRUSSELS / ADDIS ABABA / NAIROBI / LISBON / DUBLIN / PANAMA CITY / QUITO / TUNIS / ROME / HAVANA / CHICAGO / BERLIN / STOCKHOLM / NEW YORK / LONDON / BUCHAREST / SAN JOSE / LOS ANGELES – Pfizer Inc and BioNTech SE sought authorization for their COVID-19 shot to be used in children ages 12 to 15 in the European Union, potentially easing the path for schools to open broadly in the fall.

The partners plan to seek similar clearance with other drug regulators around the world, they said in a statement. The companies earlier this month requested an expansion of the US Food and Drug Administration’s emergency use authorization for their vaccine, to cover the younger age group.

The request comes as the 27-nation EU leans heavily on Pfizer and BioNTech to help it push forward an immunization campaign that still lags behind other advanced economies such as the UK and US, despite gaining ground in recent days. The bloc is seeking to buy another 1.8 billion COVID-19 vaccine doses from the partners through 2023, some of which are intended for use in children.

The Pfizer-BioNTech shot is already authorized for children as young as 16.

AstraZeneca

AstraZeneca Plc confirmed it will apply for US emergency authorization of its COVID-19 vaccine in the first half of 2021 after it missed an original target this month that raised questions over whether the company would pursue the clearance at all.

The drugmaker, which has pledged not to profit from its COVID-19 shot during the pandemic, said the product it developed with the University of Oxford recorded sales of US$275 million in the first quarter. Both sales and earnings exceeded analyst estimates in the period as the company benefited from strong growth in its cancer drugs portfolio and other key products.

Astra’s peers meanwhile stand to make billions in revenues from their COVID-19 shots. Pfizer Inc has forecast US$15 billion in sales this year from its vaccine, while Moderna Inc. expects to make about US$18 billion.

The planned request for US approval comes after a fraught time for Astra in the country. Astra had said it would apply for a US emergency use authorization by mid-April. US citizens may not see the shot in clinics in the near term though after the White House announced this month it would share its entire supply of the vaccine with other countries. The decision would make as many as 60 million vaccine doses available for export in the coming months.

The company had to row back its initial trial results after an independent monitoring panel raised concerns the data was ‘outdated’. Astra followed up with a more in-depth analysis of the more than 32,000-person trial two days later that moved the efficacy from 79 percent to 76 percent. The shot showed 100 percent efficacy against severe disease and hospitalization in both reviews.

Vials with the AstraZeneca COVID-19 vaccine against the novel coronavirus are pictured at the vaccination center in Nuremberg, southern Germany, on March 18, 2021. (PHOTO / AFP)

Africa

The number of confirmed COVID-19 cases in Africa has reached 4,550,156 as of Friday, the Africa Centers for Disease Control and Prevention (Africa CDC) said.

The Africa CDC, the specialized healthcare agency of the 55-member African Union (AU), said the death toll from the pandemic stood at 121,556 while 4,093,170 patients across the continent have recovered from the disease.

Italy

Italy administered almost 500,000 vaccine doses on Thursday, meeting a key target set by Prime Minister Mario Draghi in his effort to accelerate the country’s inoculation campaign.

Hospitals and vaccination centers gave out 497,993 shots, according to provisional data released by a government spokesman. Draghi had pledged to reach the half-million mark by April, as a faster vaccination campaign is a key condition for the easing of Covid-19 restrictions that started on Monday.

Italy on Thursday also approved a recovery and resilience plan worth 222.1 billion euros (US$269 billion) which aimed at restarting the economy affected by the coronavirus pandemic.

The green light from Draghi's cabinet came one day ahead of the Friday deadline set for European Union (EU) member states to send their recovery plans to the European Commission for review and final approval.

The recovery plan will be financed up to 191.5 billion euros by the Next Generation EU program launched by the EU last year to support the member states most affected by the COVID-19 crisis.

In the past 24 hours, Italy's Health Ministry registered 14,320 new coronavirus cases, bringing the cumulative total to over four million since the pandemic officially started in late February 2020.

France

France will allow all adults to get vaccinated against the coronavirus from June 15, President Emmanuel Macron says in a tweet on Friday.

Starting this weekend, all “vulnerable” adults, and from May 15, all those above 50, will be entitled to get vaccination.

The President has pledged that all willing adults would get vaccinated by the end of the summer. While the government has been criticized for a slow start in the vaccination campaign, it’s now picking up. Around 22 percent of the French have received at least one jab, and close to 10 percent have received two doses.

France detected its first cases of contamination with the B.1.617 variant of the novel coronavirus, currently very present in India, the country's Health Ministry said in a statement late on Thursday.

The first case, involving a woman who travelled to India and is living in southwestern France, was confirmed on Thursday, the ministry said. Two other people who travelled to India were infected with the so-called Indian variant in southeastern France, the ministry said.

Global tally

The COVID-19 cases worldwide exceeded 150 million on Friday, according to a tally of global infections by Johns Hopkins University.

The exact number stood at 150,530,783 as of 0600 GMT on Friday. More than 3.16 million people have died of the disease.

Britain

Britain said on Friday it would host a summit in 2022 to raise money for vaccine research and development to support an international coalition seeking to speed up the production of shots for future diseases.

Britain is using its presidency of the Group of Seven (G7) rich nations to highlight the need to prepare for future pandemics in light of the devastating consequences of the coronavirus crisis.

Britain said the summit with the Coalition for Epidemic Preparedness Innovations (CEPI) next year would support the body's goal of cutting the development time for new vaccines to 100 days in future pandemics.

"We look forward to working with CEPI to speed up vaccine development, creating a global solution to ensure we're better prepared for future pandemics," health minister Matt Hancock said.

CEPI, a partnership created in 2017 between public, private, philanthropic and civil society groups, played a leading role in funding early development of a range of candidate vaccines against COVID-19.

Meanwhile, Public Health England said case rates in England have fallen slightly among most age groups, with a slight rise in others.

Experts have warned that despite progress in vaccine rollout, Britain is "still not out of the woods" amid concerns over new variants, particularly those first emerged in South Africa, Brazil and India, and the third wave of pandemic on the European continent.

Russia

Russia has produced the world’s first batch – 17,000 doses – of COVID-19 vaccines for animals, its agricultural regulator said on Friday.

Russia registered Carnivac-Cov in March after tests showed it generated antibodies against COVID-19 in dogs, cats, foxes and mink.

The first batch will be supplied to several regions of Russia, the regulator Rosselkhoznadzor said in a statement.

The Russian developer of the Sputnik V coronavirus vaccine said on Thursday that it would sue the Brazilian health regulator Anvisa for defamation, accusing it of knowingly spreading false information.

Anvisa’s board on Monday rejected requests to approve Sputnik V for import. Anvisa’s medicines and biological products manager Gustavo Mendes said there was evidence an adenovirus used in the vaccine could reproduce, and that this was a serious defect.

EU

European lawmakers said on Thursday that the European Union's (EU) planned "COVID-19 certificates" – and not "Digital Green Certificates" as proposed by the European Commission – aimed at facilitating travel across the bloc should be enough to enable free movement this summer.

On Thursday, members of the European Parliament (MEPs) adopted their negotiating position on the Commission's proposal, according to which EU member state governments should not impose quarantines, tests or self-isolation measures on certificate holders.

In its proposal presented in March, the Commission said the temporary system will be suspended once the World Health Organization (WHO) declares the end of the COVID-19 international health emergency.

MEPs insisted on Thursday that the new "EU COVID-19 certificate" should be in place for a maximum of 12 months.

Following Wednesday's vote, the results of which were announced on Thursday, negotiations between the European Parliament and the EU Council can start with the goal of having a deal approved in June, ahead of the summer season.

The Commission proposed last month that the certificates should be given to EU residents who can prove they have been vaccinated as well as to those who have a recent negative test result or can prove they have recovered from the infection.

WHO

Many African countries are at high risk of COVID-19 resurgence amid lax adherence to containment measures combined with low vaccination and testing, a World Health Organization (WHO) official said Thursday.

Matshidiso Moeti, WHO regional director for Africa, said the continent could witness a dramatic spike in new infections and fatalities unless mass gatherings were suspended and the wearing of masks was strictly enforced.

"We cannot be lulled into a false sense of security. The devastating surge of cases and deaths in India and increases in other regions of the world are clear signs that the pandemic is not yet over in African countries," Moeti said in a statement.

Statistics from Africa Centers for Disease Control and Prevention (Africa CDC) indicate the continent's COVID-19 caseload stood at 4.53 million while fatalities tally stood at 121,154 as of Thursday.

Moeti said the continent has escaped the worst of the pandemic, warning that complacency and disregard for public health measures could trigger a new wave of infections.

"A new upsurge of COVID-19 infections is a real risk in many countries even if the region's case count in recent weeks appears to be stable. Combating COVID-19 fatigue appears to be the key battle in our collective response to the pandemic," said Moeti.

The latest risk assessment conducted in 46 African countries by WHO indicates that three face very high risk of COVID-19 resurgence, 20 face high, 22 face moderate and only one is facing low risk of the pandemic.

Some of the parameters used in the risk assessment included new dynamics in the virus transmission, the number of tests conducted, case fatality rate and vaccination trends.

Portugal

Prime Minister Antonio Costa said on Thursday that Portugal will  reopen its land borders with Spain and move to the final stage of gradually easing COVID-19 restrictions starting from May 1.

In a speech to the nation following a cabinet meeting, Costa said that an intermediate level of civil protection will be adopted, with no restrictions on individual freedoms and rights, leaving only the recommendation of health standards and some restrictions on commercial activities.

He said, however, that the decision does not mean that the country has overcome the pandemic, "but only give a step forward for the next stage of deconfinement."

The prime minister said that the pandemic indicators "clearly demonstrate a lower incidence and a risk of controlled transmissibility."

"We must remember that nothing is guaranteed for the future. This is a daily struggle and the wish we all have is that we can proceed with continuity, with caution, while the vaccination process is progressing at an increasing pace," said Costa.

Ireland

Irish Prime Minister Micheal Martin on Thursday announced a phased plan to further ease the country's current COVID-19 restrictions starting from next month.

According to the plan, all construction projects can restart from May 4.

From May 10, inter-county travel in Ireland will be allowed; non-essential retail outlets can resume click and collect services; personal services such as barber shops and beauticians can reopen, but customers must make appointments in advance.

From May 17, all non-essential retail outlets can fully resume their business.

Starting from June 2, subject to the public health situation at the time, accommodation services such as hotels and hostels can reopen, but services must be restricted to overnight guests and local residents.

From June 7, people can receive guests from one other household inside their home; all restaurants and bars can provide outdoor services with groups limited to six people; outdoor sports matches can be played but with no spectators; gyms, swimming pools and leisure centers can reopen but only for individual training purposes.

The Irish Department of Health on Thursday also reported another 474 confirmed cases of COVID-19 and three additional deaths related to the virus.

To date, close to 250,000 people in Ireland have been infected with COVID-19 and nearly 4,900 of them have died from the disease, said the department.

Brazil

Brazil recorded more COVID-19 deaths in the first four months of the year than in all of 2020, breaching the 400,000 mark as it grapples with a shortage of shots that’s threatening mass vaccinations.

The Health Ministry reported 3,001 deaths on Thursday, pushing the total to 401,186 since the pandemic started a little over a year ago. It’s the second highest tally globally, trailing only the US Cases rose by 69,389 in the past 24 hours, pushing the toll to 14.6 million, behind India and the US.

Brazil's COVID-19 deaths have fallen slightly from a peak of more than 4,000 in a single day in early April, prompting many local governments to ease lockdowns.

But infectious disease experts warned that this easing will keep deaths elevated for months as vaccines alone cannot be counted on to contain the virus. Two experts said they expect deaths to continue to average above 2,000 per day.

"Brazil will repeat the same mistake as last year," said epidemiologist Pedro Hallal, who led a national study on COVID-19.

The surge in infections is being driven by the P.1 coronavirus variant discovered in Brazil that is believed to be 2.5 times more contagious that the original version.

The experts blamed the death toll on the failure of government – from President Jair Bolsonaro to many state governors and mayors – to launch a strong enough response to the pandemic.

"We have reached this number of 400,000 deaths mainly because of the managerial incompetence of this government, led by the president," said Jamal Suleiman, a doctor at the Emilio Ribas Infectology Institute.

Bolsonaro has downplayed the severity of the virus since the beginning, opposed strict lockdown measures, failed to strongly endorse masks and only recently embraced vaccines.

A woman pulls a cart with a tank of cooking gas past a banner with a message that reads in Portuguese; "I don't care," spoofing Brazil's President Jair Bolsonaro, during a solidarity campaign to sell fuel at low prices by the Petrobras Oil Tankers Union, in Rio de Janeiro, Brazil on April 29, 2021. The union also promoted the sale as a protest against Bolsonaro and his handling of the pandemic. (SILVIA IZQUIERDO / AP)

Panama

Panamanian President Laurentino Cortizo on Thursday characterized as positive the results of the country's management and health strategy to curb COVID-19, but urged Panamanians not to lower their guard because "we have not won the war."

"Without health, economic reactivation is impossible," Cortizo stressed during the virtual inauguration of the new board of directors of the Chamber of Commerce, Industries and Agriculture of Panama.

The president added that "the reality in the world, the region and neighboring countries confirms that we have many battles ahead of us," in reference to the impact of the pandemic.

He pointed out that his administration's priority has been to avoid the collapse of the country's health system, and noted that its vaccination strategy is working as planned.

According to a report issued on Wednesday by the Ministry of Health, Panama has accumulated 363,895 COVID-19 cases and 6,222 deaths.

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Ecuador

Ecuador's Ministry of Public Health reported on Thursday 3,027 new COVID-19 infections and 52 more deaths in the last 24 hours, bringing the national counts to 380,689 and 18,552 respectively.

The South American country is facing a rise in infections, with overcrowded hospitals and long waiting lists for intensive care unit beds.

Authorities in Ecuador also reported a reduction in pressure on hospitals and citizen indiscipline on Thursday due to the state of emergency in force since April 23 in 16 of the country's 24 provinces to curb the spread of COVID-19.

At a joint press conference, officials from the National Emergency Operations Committee (COE) confirmed that the measure decreed by the government is producing "encouraging" results.

The state of emergency, which will last until May 20, includes a night curfew, a ban on gatherings and a total weekend lockdown.

Taking stock of the period between last weekend and Wednesday, COE President Juan Zapata said that 114 agglomerations were recorded, a 79-percent decrease compared to the 540 documented during the same period before the state of emergency.

Tunisia

Tunisian Health Ministry reported on Thursday 1,902 new COVID-19 cases, raising the total number of infections in the country to 307,215.

The death toll from the virus rose by 78 to 10,641 in Tunisia, the ministry said in a statement.

The number of hospitalized COVID-19 patients in the North African country reached 2,788, including 519 in intensive care units, while the total number of recoveries hit 258,190, it said.

Cuba

Cuba reported on Thursday 18 COVID-19 deaths in the last day, the highest recorded figure for one day, bringing the total to 632, the Ministry of Public Health said, adding that there were also 1,149 new infections to total 105,661 cases.

"These numbers force us to protect ourselves more and more to avoid infections," warned the ministry's national director of hygiene and epidemiology Francisco Duran.

Havana, which reported 16 of the 18 deaths and 758 cases in the last day, is the epicenter of the pandemic in the country, with an incidence rate of 432.5 infections per 100,000 inhabitants, the highest on the island.

Cuba has been facing a new wave of COVID-19 infections since January, as authorities have moved to regulate the closure of many public spaces, restrict mobility, and require testing and quarantining for arriving travelers.

United States

Chicago Mayor Lori Lightfoot announced on Thursday that the US third largest city is loosening up its pandemic restrictions by allowing outdoor festivals and farmers markets and increased capacity for indoor events at the United Center and elsewhere.

This is part of the city's plan to reopen the economy to normal events, Chicago Tribune reported on Thursday.

Los Angeles County is also ready to further reopen businesses next week, said the county's public health department in a news release Thursday.

The county is on track to move into the least restrictive yellow COVID-19 tier of California's four-tier, color-coded system amid dropping cases and vaccine eligibility expansion.

Moving into the yellow tier allows for increases in capacity in many sectors, such as amusement parks, fairs, gyms, museums, zoos, and aquariums, according to the department.

Officials noted that COVID-19 case rate currently remains relatively low and stable in the county, which was once an epicenter of the pandemic in the United States.

"A month ago, on March 21, the county was seeing 433 cases a day. A month later, on April 21, the number of new cases dropped 34 percent to 337 cases a day. Over the same time period, daily average confirmed hospitalizations dropped 38 percent," said the county's public health officials, adding that daily deaths dropped more than 80 percent over the same time period.

In New York City, a plan to fully reopen businesses, offices, restaurants and theaters will start from July 1, said New York City Mayor Bill de Blasio on Thursday.

"Based on all the progress that we've made in this city, we can go back to full strength," de Blasio said at a TV program.

As many as 8.99 million residents in New York State had got at least one shot of COVID-19 vaccine as of Wednesday, accounting for 45.1 percent of the total population in the state, according to the local vaccination tracking program.

As an early epicenter of the pandemic in the United States, New York City reported over 32,461 deaths and 923,953 cases from COVID-19 as of Wednesday.

Germany

COVID-19 case numbers in Germany are no longer rising rapidly but are still "too high overall," said Lothar Wieler, president of the Robert Koch Institute (RKI), at a press conference here on Thursday.

"The third wave has successfully been slowed down," he said. "Unfortunately, it is too early for an all-clear."

The number of confirmed cases in Germany increased by 24,736 within one day on Thursday. This figure was around 4,700 lower than one week ago, the RKI said.

At the same time, the number of cases among under-60s in Germany went up and there was a significant increase in cases among children, Wieler said. The situation also remains "tense" at the country's intensive care units.

Progress in vaccination would "give hope," Minister of Health Jens Spahn said. An improvement is "noticeably in sight" as COVID-19 vaccinations create the conditions for a gradually return to "normality."

Sweden

After a disastrous year due to COVID-19, travel agencies in Sweden have been busier than usual for the 2021 winter season (October through March). The rollout of vaccines and "COVID passports" has restored confidence among people yearning for holidays, but business travel will take longer to recover, according to the Association of Swedish Travel Agents and Tour Operators (SRF).

The bounceback comes after a year in which international travel made by Swedes decreased by more than 90 percent, forcing SRF member companies to lay off around 4,000 employees or half of their staff.

"It's been disastrous, but now there's a budding optimism," Didrik von Seth, director general of the association that represents nearly 300 travel companies, told Xinhua. "We see that bookings for the winter season are at a higher level than it's usual at this time of year."

He said he also expected massive demand for the summer of 2022. "Most people have not traveled for more than a year now and there is a pent-up urge to travel," he said, noting many have also saved money on holidays and activities during the pandemic.

"This is vital for the European economy, where the tourism industry employs ten percent of the workforce," von Seth said.

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Romania

Romania confirmed its first case of the coronavirus variant first detected in India in an Indian construction worker from Brasov County, central Romania, the Health Ministry announced in a press release on Thursday.

According to the release, the ministry was informed by the National Institute of Public Health (INSP) that a local laboratory identified the variant B.1.617.2, one of the sub-lineages of the B.1.617 strain, in a 26-year-old person who arrived in Romania about a month ago.

An epidemiological inquiry has been launched as a matter of urgency. Of the eight people arriving from India, five have been confirmed with COVID-19 infection and three others tested negative. All contacts were tested and quarantined.

Romania is stepping up its vaccination campaign launched on Dec. 27, 2020. As of Wednesday, more than 3.201 million Romanians had been vaccinated, over 1.880 million of them with two doses.The government's objective is to vaccinate ten million people — about half of the country's population — as soon as possible: five million by June 1 and all ten million by Aug 1.

Currently, vaccines produced by Pfizer/BioNTech, Moderna and AstraZeneca are being used in Romania.

Chile

Chile, a global leader in vaccination, is considering issuing a "green card" to those inoculated against the coronavirus in an effort to encourage younger adults who may be reluctant to turn out for their shots, health officials said on Thursday.

Chile's vaccination drive is the fastest in Latin America thus far, and among the top five globally in terms of percentage of its population with at least one shot, according to a Reuters tabulation.

But a recent slowdown in the pace of vaccination has prompted health officials to fast-track a possible rollout of two government-issued ID cards: a domestic "green card" and an international travel "green passport," perks aimed to incentivize participation in the drive, officials said.

"We are looking at it and I think it could be a very important stimulus for people to get vaccinated," Health Minister Enrique Paris told reporters, adding the effort was important to "maintain our campaign."

Costa Rica

Costa Rica will for the next week close non-essential businesses, including restaurants and bars, across the center of the country due to a sharp increase in new cases of COVID-19 and hospitalizations, the government said on Thursday.

From May 3-9, restaurants, department stores, beauty salons, gyms and churches must close in 45 municipalities in central Costa Rica, where almost half the population lives and over two-thirds of new cases have been registered.

"We are in an unprecedented situation, and many people are going to die," Health Minister Daniel Salas said after announcing 2,781 new daily infections, a record number. "There are already waiting lists to enter intensive care."

The government will also impose travel restrictions during the week.

Costa Rica has so far reported almost 249,000 cases of COVID-19 and some 3,200 fatalities.

Some 10.5 percent of the population had been vaccinated as of Thursday, most of them over the age of 58, official data show.

Hungary

Hungary's Prime Minister Viktor Orban on Friday said parts of the service economy will reopen as scheduled on Saturday as the country's COVID-19 vaccination rate surpasses 40 percent, adding he would slowly refocus on kick-starting economic growth.

Hungary has the highest cumulative per capita coronavirus death toll in the world, according to worldometers.info, but the third wave of its epidemic is slowly receding.

Orban who, to criticism from Brussels and from domestic political opponents, has imported vaccines from China and Russia that have yet to receive EU approval, told public radio there were enough shots in the country to inoculate everyone who has registered for them.

"Vaccines are like a bulletproof vest," the premier told state radio. "We now have one for everybody, please come and suit up so the virus has no one to attack."

The economy suffered a deep recession in all of 2020, and Orban said he would insist on an expansionary budget for 2022.

"I think we will reach pre-pandemic economic levels faster than some may think," said Orban, whose government currently projects a growth rate of 4.3% this year and over 5 percent in 2022.

The premier, who faces his first tight election race in 2022 since assuming power a decade ago, has leveraged the rapid vaccine rollout to try to shore up his support base.