Published: 09:25, September 23, 2021 | Updated: 23:46, September 23, 2021
Novavax applies to WHO for emergency listing of vaccine
By Agencies

A health worker injects a syringe with a vial of the Phase 3 Novavax coronavirus vaccine for use in the trial at St. George's University hospital in London, Oct 7, 2020. (ALASTAIR GRANT / AP)

BRASILIA / KAMPALA / MOSCOW / UNITED NATIONS / WASHINGTON / ADDIS ABABA / LONDON / ROME / BERLIN / BUCHAREST / MEXICO CITY / TBILISI / MADRID / ANCHORAGE / KYIV / STOCKHOLM - Novavax Inc and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing of Novavax's COVID-19 vaccine, the company said on Thursday.

The WHO's emergency use listing is a signal to national regulatory authorities on a product's safety and efficacy.

Novavax and Serum Institute, the world's largest vaccine producer, have committed to together provide more than 1.1 billion doses to the COVAX facility, which aims to provide equitable access to COVID-19 vaccines to low- and middle-income countries

It is also a prerequisite for export to several countries participating in the COVAX vaccine sharing facility.

Novavax has said it would focus on low- and middle-income countries for initial supplies of the vaccine, as the United States and other Western nations have already vaccinated a large part of their populations with other vaccines.

Novavax had previously said it would apply for the listing in August, marking a slight delay in the filing.

Novavax and Serum Institute, the world's largest vaccine producer, have committed to together provide more than 1.1 billion doses to the COVAX facility, which aims to provide equitable access to COVID-19 vaccines to low- and middle-income countries.

The Novavax shot is a protein-based vaccine, and was shown to be more than 90 percent effective, including against a variety of concerning variants of the coronavirus in a large, late-stage US-based clinical trial.

Egypt

Egypt will start shipping locally-made COVID-19 vaccines to other African nations in the next month and a half, Health Minister Hala Zayed said Thursday.

Addressing reporters in the capital, Cairo, she didn’t give further details on the types or amounts of vaccines, nor how they were being paid for.

The Arab world’s most populous nation is seeking to become a hub for vaccine exports, with Egyptian company Vacsera this year starting to produce Sinovac using materials sent from China.

Zayed also said authorities were in discussions with Moderna Inc. to produce its vaccine locally and plan to begin negotiations with BioNTech SE.

Health Ministry official Mohamed Hassani told Bloomberg at the same event that 15 million people had received vaccinations in Egypt so far, with 5 million of them getting two doses.

Sweden

Sweden is looking into giving a third dose COVID vaccine to a larger part of the population over fears that the protective effect of the two shots most have had could start wane, the country's public health agency said on Thursday.

Sweden has vaccinated 83 percent of the population aged over 16 with one dose and 76 percent with two doses. The health agency recently identified some 40,000 people in need of a third dose, but said on Thursday more could soon be eligible.

"There are signals from abroad that indicate the protection from the vaccination is fading after some time, especially in those who are older," Public Health Agency official Sara Byfors told a news conference. "It is important to meet that with a third dose."

The number of infections in Sweden has decreased quickly in the last two weeks, but there have been several cluster outbreaks at elderly care facilities, with some of them leading to fatalities.

Sweden has opted against lockdowns during the pandemic, instead focusing on mostly voluntary measures. Most measures and recommendations will be ended next week.

It has had several times more deaths per capita from the pandemic than its Nordic neighbors, but lower than in most European countries that opted for lockdowns.

Russia

Russia on Thursday reported 820 coronavirus-related deaths in the last 24 hours, matching an all-time one-day high that it last reached on Aug 26.

The government coronavirus task force also said it had recorded 21,438 new COVID-19 cases in the last 24 hours, taking the national tally to 7,354,995 since the pandemic began.

The government said Wednesday Russia will resume passenger flights with Denmark, South Africa, New Zealand, Peru and Djibouti from Oct 5.

ALSO READ: Report: Almost 40m Russians fully vaccinated against virus

UN General Assembly

Leaders from developing nations warned the UN General Assembly this week that COVID-19 vaccine hoarding by wealthy countries left the door open for the emergence of new coronavirus variants even as infections already increase in many places.

The Philippines warned of a "man-made drought" of vaccines in poor countries, Peru said international solidarity had failed and Ghana lamented vaccine nationalism. The United Nations chief described the inequitable distribution of COVID-19 vaccines as an "obscenity".

"Rich countries hoard life-saving vaccines, while poor nations wait for trickles," Philippines President Rodrigo Duterte said at the high-level gathering on Tuesday.

"They now talk of booster shots, while developing countries consider half-doses just to get by. This is shocking beyond belief and must be condemned for what it is – a selfish act that can neither be justified rationally nor morally."

The African continent bears the worst brunt of vaccine nationalism, Ghana President Nana Akufo-Addo told the gathering on Wednesday. About 900 million Africans are still in need of vaccines in order to reach the 70 percent threshold achieved in other parts of the world.

Colombian President Ivan Duque said COVID-19 vaccines must be equitably distributed to avoid the creation of new, more fearsome variants of the coronavirus. 

Some countries have acquired enough doses for six or seven times their population and have announced third booster doses, Duque added, while others have not been able to administer any shots.

Peru's new leftist president, Pedro Castillo, said at the gathering he was proposing an international agreement between heads of state and the owners of COVID-19 vaccine patents "to guarantee universal access" to the shots.Ghana's President Nana Addo Dankwa Akufo-Addo addresses the 76th session of the United Nations General Assembly in a pre-recorded message, at the UN headquarters, Sept 22, 2021. (JUSTIN LANE / POOL PHOTO VIA AP)

Global tally

Coronavirus worldwide exceeded 230 million while the global death toll topped 4.7 million, according to data compiled by Johns Hopkins University.

ALSO READ: J&J says its booster shot prevents severe infection

Africa

The number of confirmed COVID-19 cases in Africa reached 8,177,919 as of Wednesday noon, the Africa Centers for Disease Control and Prevention (Africa CDC) said.

The death toll from the pandemic stood at 207,132 while some 7,534,544 patients across the continent have recovered from the disease, the Africa CDC said.

Americas

The Pan American Health Organization (PAHO) warned on Wednesday that countries in the region could continue to face localized COVID-19 outbreaks "well into 2022" even while deaths have fallen from their peak in January.

While vaccinations are progressing, the region faces a "severe vaccine inequality problem" that will prolong the pandemic, particularly in the poorer Latin American nations, PAHO said in a report to its annual policy-setting meeting.

That means continued need for preventive measures, including procedures for early detection, investigation and isolation of infected cases, and the tracing and quarantine of contacts. Renewed outbreaks are to be expected in institutions such as nursing homes, prisons and densely-populated urban areas.

While vaccination coverage may reach high levels overall, much will depend on vaccine supply availability, which is limited worldwide, and the access and demand among specific population groups, PAHO said.

"Vaccine hesitancy may further slow uptake by the population or prevent full achievement of vaccination potential," reads the report by the regional branch of the World Health Organization.

In its update on the COVID-19 situation in the Americas, PAHO said almost all he countries and territories in the region have reported detection of at least one of the four COVID variants that are of concern.

Half of them have detected the highly transmissible Delta variant, which is now the dominant strain in Canada, Mexico and the United States, according to PAHO.People wait in line to be vaccinated with the AstraZeneca COVID-19 vaccine in Managua, Nicaragua, Sept 20, 2021. (MIGUEL ANDRES / AP)

Antibodies from vaccinated pregnant women

Pregnant women who get mRNA vaccines pass high levels of antibodies to their babies, according to a study published in American Journal of Obstetrics & Gynecology – Maternal Fetal Medicine on Wednesday.

The study - one of the first to measure antibody levels in umbilical cord blood to distinguish whether immunity is from infection or vaccines - found that 36 newborns tested at birth all had antibodies to protect against COVID-19 after their mothers were vaccinated with shots from Pfizer Inc.-BioNTech SE or Moderna Inc. 

“We pushed this data out relatively early because it’s a unique finding and it has important implications for care,” said Ashley Roman, an obstetrician at NYU Langone Health System and co-author of the study. “Right now we’re recommending all pregnant women receive the vaccine for maternal benefit.”

The researchers studied cord blood of 36 fully vaccinated women to look for antibodies to spike protein, which appears after vaccination or getting sick from COVID-19, and to nucleocapsid protein, which is only present after getting COVID-19. Prior studies focused on antibodies to the spike protein.

Among the 36 samples the researchers looked at, 31 tested negative for antibodies to the nucleocapsid protein. In other words, 31 pregnant women developed immunity from the vaccine. The other five weren’t tested for nucleocapsid protein, so the researchers can’t conclusively say the immunity was from the vaccine or from natural infection.

Brazil

Brazilian President Jair Bolsonaro, just back from the United Nations, isolated himself at home on Wednesday and canceled a trip after his health minister tested positive for COVID-19 and had to stay in quarantine in New York.

Brazil's health regulator Anvisa recommended that the entire presidential delegation to the UN General Assembly remain in isolation and undergo more tests. Bolsonaro's only appointment on Wednesday was changed to a remote meeting.

Health Minister Marcelo Queiroga tested positive hours after accompanying Bolsonaro - who is unvaccinated - to give the first speech from a head of state at the annual assembly on Tuesday, the government said. It added that the other delegation members all tested negative.

Queiroga accompanied Bolsonaro to a meeting on Tuesday morning at the UN building with British Prime Minister Boris Johnson. The health minister was seen wearing a mask, although the two leaders went without.

Brazil's government has told the UN that its complete delegation has decided to self-quarantine for fourteen days, UN spokesman Stephane Dujarric said.Brazil President Jair Bolsonaro (center( leaves th eUnited Nations headquarters after addressing the 76th Session of the UN General Assembly in New York on Sept 21, 2021. (JOHN MINCHILLO / POOL / AP)

In another development, Anvisa said Wednesday that the death of a 16-year-old who had a first dose of the Pfizer/BioNTech vaccine was due to a prior blood clot condition not related to the vaccine.

Concluding an investigation into the death earlier this month, Anvisa said it was caused by an auto-immune disease suffered by the adolescent. The Pfizer vaccine is the only one approved for minors in Brazil.

Brazil had 36,473 new cases of the novel coronavirus reported in the past 24 hours, and 876 deaths from COVID-19, the health ministry said on Wednesday.

The South American country has now registered 21,283,567 cases since the pandemic began, while the official death toll has risen to 592,316, according to ministry data.

ALSO READ: Germany worried as millions of elderly still lack virus shots

Ethiopia

Ethiopia registered 1,489 new COVID-19 cases in the past 24 hours, taking the national tally to 336,762 as of Wednesday evening, said the country's health ministry.

The death toll rose by 47 to 5,254 while the number of recoveries increased by 1,179 to 5,254 304,768.

According to the ministry, Ethiopia currently has 26,738 active cases, including 789 in severe health conditions.

Georgia

Georgia on Wednesday reported 2,016 new COVID-19 cases, taking its tally to 600,412, according to the country's national center for disease control.

Data from the center showed that 2,024 more patients have recovered in the past 24 hours, taking the total number of recoveries to 567,797.

Meanwhile, 43 people died in the last 24 hours, raising the death toll to 8,664.

As of Wednesday, the country has administered a total of 1,686,412 doses of COVID-19 vaccines.

Germany

Germany will stop paying compensation to unvaccinated workers who are forced into quarantine by coronavirus measures as it is unfair to ask taxpayers to subsidize those who refuse to get inoculated, Health Minister Jens Spahn said on Wednesday.

The rules, which will be implemented by the governments of Germany's 16 federal states, will take effect by Oct 11 at the latest, Spahn said, confirming the details of a draft document seen earlier by Reuters.

The rules will affect people who test positive for the virus and those returning from trips to countries designated "high risk" for COVID-19, which now include Britain, Turkey and parts of France, among others.

Unvaccinated travelers from such countries are required to quarantine for at least five days. Those who have been vaccinated or have recently recovered are not required to do so.

COVID-19 tests, required for example to dine in indoor restaurants, will stop being free of charge from Oct. 11.

Also, some German states are allowing businesses such as restaurants or sports stadiums to choose whether to admit people with negative tests, or only those who have been vaccinated or have recently recovered from COVID-19.

Germany has fully vaccinated 74 percent of adults, compared to 72.3 percent across the European Union as a whole, official data show.

A man receives a Johnson & Johnson Janssen COVID-19 vaccine in a so-called 'Impfzug' (vaccination train) operated by Berliner S-Bahn in Gruenau near Berlin, Germany, on Aug 30, 2021, the start of a vaccination campaign on Berlin's circular Ringbahn railway. (TOBIAS SCHWARZ / AFP)


Italy

Italy plans to give other countries 45 million doses of COVID-19 vaccines before the end of the year, three times its original pledge, Prime Minister Mario Draghi said on Thursday.

In a video message to a US-hosted global COVID-19 Summit, Draghi said his government had previously promised to donate 15 million doses of vaccine by the end of the year.

"Nearly half of these have already been delivered and today I am glad to announce that we will triple our efforts. We will donate another 30 million additional doses by the end of the year to reach 45 million," he said.

Lithuania

Lithuania registered 1,402 new COVID-19 infections and nine deaths in the past 24 hours and moved into the worst "black zone" under the color-coded national classification system.

A "black zone" means that the 14-day rate of new coronavirus cases exceeded 500 per 100,000 people and the percentage of positive tests is above ten percent. The number climbed to 504.5 on Tuesday.

Since the middle of July, Lithuania's COVID-19 infection rate has been steadily increasing. In the past seven days, the average daily number of reported new cases was 1,142 and the average number of deaths was 11 per day.

On Sept 13, Lithuania made COVID-19 certificates mandatory for all people wishing to enter larger shops.

Mexico

Mexico recorded 11,603 newly confirmed coronavirus cases and 811 more fatalities on Wednesday, according to health ministry data, bringing the overall number of confirmed cases to 3,597,168 and the overall death toll to 273,391.

Moderna

Moderna Inc Chief Executive Stéphane Bancel thinks the coronavirus pandemic could be over in a year as increased vaccine production ensures global supplies, he told the Swiss newspaper Neue Zuercher Zeitung.

"If you look at the industry-wide expansion of production capacities over the past six months, enough doses should be available by the middle of next year so that everyone on this earth can be vaccinated. Boosters should also be possible to the extent required," he told the newspaper in an interview.

Vaccinations would soon be available even for infants, he said.

"Those who do not get vaccinated will immunize themselves naturally, because the Delta variant is so contagious. In this way we will end up in a situation similar to that of the flu. You can either get vaccinated and have a good winter. Or you don't do it and risk getting sick and possibly even ending up in hospital."

Asked if that meant a return to normal in the second half of next year, he said: "As of today, in a year, I assume."

Bancel said he expected governments to approve booster shots for people already vaccinated because patients at risk who were vaccinated last autumn "undoubtedly" needed a refresher.

Panama

Panama will offer COVID-19 vaccines to foreign visitors in the near future now that most of its own citizens are fully inoculated, the nation’s Trade and Industry Minister said. 

“Next month we’re going to have more than 70 percent of our population with two vaccines and that’s been one of the keys of our economic plan for recovery,” Trade and Industry Minister Ramon Martinez told Bloomberg Television’s Shery Ahn in an interview in New York.

“We’re going to open for tourists to visit Panama and get vaccinated, and allow them to see the other wonders that Panama has.”

Romania

Romania reported the year's highest daily number of coronavirus infections on Wednesday as cases doubled within a week, authorities said, amid relatively low vaccination rates and the reopening of schools after the summer break.

The Black Sea state is trailing in European Union's vaccination lists amid widespread distrust in state institutions, with nearly 31 percent of its eligible 12+ population inoculated so far, just ahead of the bloc's laggard Bulgaria.

The EU's average vaccination rate reached 70 percent in September.

"Schools act as an accelerator of intra-community transmission. It's like going in the first gear in the community, and then shifting instantly to the fifth gear, when they get to school," said public health expert Razvan Chereches.

Government data showed COVID-19 infections hit the year's peak for the second day in a row on Wednesday, with 7,045 positive cases out of 54,000 tests over the past day. The peak in 2020 was about 10,300 infections.

About 35,800 people have died since the beginning of the outbreak in the country of 20 million, with numbers now around 130 a day, having risen from roughly two people a day in between the third and fourth waves.

Spain

Spain will donate 7.5 million doses of COVID-19 vaccine to Latin America and the Caribbean and a further 7.5 million to sub-Saharan Africa and Southern Europe, Prime Minister Pedro Sanchez said on Wednesday.

The latest pledge increases Spain's overall commitment to the COVAX vaccine sharing program to 30 million doses, Sanchez told reporters before appearing at the UN General Assembly in New York.

People wait to receive coronavirus vaccinations at a streetside vaccination tent in downtown Kampala, Uganda, Sept 7, 2021. (NICHOLAS BAMULANZEKI / AP)

Uganda

Ugandan President Yoweri Museveni on Wednesday called for massive mobilization for the inoculation of the priority groups before some COVID-19 vaccines donated to the country expire.

About 67,000 vaccines are to expire at the end of September, Museveni said in a televised address on the COVID-19 situation in the east African country.

Meanwhile, Museveni eased anti-coronavirus restrictions, including allowing resumption of education for universities and other post-secondary institutions, citing a decline in infections in the country.

He said all universities and other post secondary education institutions should now reopen on Nov 1 and also allowed churches and a range of other sport and social activities such as weddings and funerals to resume.

Bar closures and a range of other restrictions such as a night curfew would be maintained though, to help prevent a third wave of the pandemic, he said.

Museveni also instructed that border surveillance be enhanced to stop possible inrush of new COVID-19 variants.

The health ministry will conduct regular and systematic genomic sequencing to detect any new variants locally transmitted or imported, he said.

As of Wednesday, Uganda had registered 122,502 confirmed cases and 3,135 deaths.

UK

England's Chief Medical Officer Chris Whitty on Wednesday said that children were currently driving transmission of COVID-19 at the moment, and that without vaccination, almost all 12- to 15-year-olds would get infected at some point.

"There is definitely substantial transmission happening in this age group. In fact, the age group we're talking about is the one in which the highest rate of transmission is currently occurring, as far as we can tell," Whitty told lawmakers at a session about the decision to offer COVID-19 vaccines to children aged 12-15.

All children in that age group will be offered a COVID-19 vaccine after Whitty and his colleagues said last week that children would benefit from reduced disruption to their education.

READ MORE: Pfizer's virus shot safely bolsters antibodies in younger kids

Britain recorded 34,460 new COVID-19 cases on Wednesday and a further 166 deaths within 28 days of a positive coronavirus test, government data showed.

In total, Britain has reported 7,530,103 confirmed cases and 135,621 deaths, the data showed.

Ukraine

Ukraine tightened coronavirus lockdown curbs on Thursday, restricting large events and occupancy at gyms, cinemas and cultural sites, after a recent steady increase in new infections.

Ukraine imposed a nationwide "yellow" code after cases dropped over the summer, allowing it to lift lockdown restrictions.

This week, however, the government extended a state of emergency that allows authorities to impose curbs until year-end to rein in infections.

The government on Wednesday also announced that it will introduce a compulsory COVID-19 vaccination for civil servants and education workers.

The vaccination coverage among other priority professional groups in Ukraine, namely healthcare, defense and law enforcement workers, has reached 80 percent, Health Minister Viktor Liashko said.

As of Wednesday, Ukraine has registered 2,362,559 COVID-19 cases, 55,161 deaths and 2,235,668 recoveries, according to the health ministry.

More than 5.2 million Ukrainians have been fully vaccinated so far, according to official data.

US

The US Food and Drug Administration on Wednesday authorized a booster dose of the Pfizer Inc and BioNTech COVID-19 vaccine for those aged 65 and older and some high-risk Americans, paving the way for a quick rollout of the shots.

The booster dose is to be administered at least six months after completion of the second dose, and the authorization would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.

A US Centers for Disease Control and Prevention (CDC) advisory panel could vote on Thursday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday.

In another development, the United States on Wednesday promised to buy 500 million more COVID-19 vaccine doses to donate to other countries as it comes under increasing pressure to share its supply with the rest of the world.

President Joe Biden made the announcement during a virtual summit aimed at boosting global vaccination rates against the coronavirus and rallying world leaders to do more.

Separately, Alaska, which led most US states in coronavirus vaccinations months ago, took the drastic step on Wednesday of imposing crisis-care standards for its entire hospital system, declaring that a crushing surge in COVID-19 patients has forced rationing of strained medical resources.

Governor Mike Dunleavy and health officials announced the move as the tally of newly confirmed cases statewide reached another single-day record of 1,224 patients amid a wave of infections driven by the spread of the highly contagious Delta variant among the unvaccinated.

Valneva

Valneva SE said it’s expanding clinical trials of its COVID-19 inoculation and is still in talks with the European Union on a supply contract, as the French company tries to advance its vaccine development after the UK government canceled an order this month.

The company said Thursday it has begun enrolling adolescents in a third-phase trial, and it expects ongoing tests to provide some results in the fourth quarter, which are intended to form the basis for gaining regulatory approval for use in adults.

Valneva also said it’s pursuing other customers as well as continuing discussions with the European Commission. 

The French company also said it has begun giving booster shots to adults in an earlier-stage trial.

Valneva’s vaccine works by taking a sample of the disease that has been killed and using it to stimulate an immune response without creating infection.