Tag Archives: COVID-19 vaccine

U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director

WASHINGTON (Reuters) – The United States has delivered about 3 million COVID-19 vaccine doses per day on average over the past week, up 8% over the previous 7-day average, U.S. Centers for Disease Control and Prevention Director Rochelle Walensky said on Wednesday.

Still, daily U.S. cases of novel coronavirus are averaging 63,000 over the past seven days, up 2.3% from the previous 7-day average, she told reporters at a White House briefing.

(Reporting by Susan Heavey, Jeff Mason and Carl O’Donnell)

U.S. puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca

By Shubham Kalia

(Reuters) – The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.

J&J said it was “assuming full responsibility” of the Emergent BioSolutions facility in Baltimore, reiterating that it will deliver 100 million doses to the government by the end of May.

In a separate statement late Sunday, Emergent said it expects to align with the U.S. government and AstraZeneca to ramp down manufacturing for AstraZeneca’s COVID-19 vaccine at its Baltimore plant.

The Department of Health and Human Services has also increased Emergent’s order by $23 million for expansion of production specific to J&J’s vaccine doses, Emergent added.

“The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility,” the company said.

The Department of Health and Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

AstraZeneca, whose vaccine has not been approved in the United States, said it will work with President Joe Biden’s administration to find an alternative site to produce its vaccine.

White House officials did not immediately respond to a request for comment.

The development, first reported by the New York Times, further hampers AstraZeneca’s efforts in the United States. The government has criticized the drugmaker for using outdated data in the results of its vaccine trial. It later revised its study.

Workers at the Emergent BioSolutions plant several weeks ago conflated ingredients for the J&J and AstraZeneca vaccines, the Times said earlier in the week. J&J said at the time the ruined batch had not advanced to the fill-and-finish stage.

The government’s move to have the facility make only the J&J single-dose vaccine is meant to avoid future mix-ups, the Times said, citing two senior federal health officials.

The top U.S. infectious disease doctor told Reuters on Thursday the country may not need AstraZeneca’s vaccine even if it wins approval.

The United States has loan deals to send Mexico and Canada roughly 4 million doses of the AstraZeneca vaccine, made at its U.S. facility.

(Reporting by Shubham Kalia, Vishal Vivek and Aakriti Bhalla in Bengaluru; Additional reporting by Steve Holland in Washington; Editing by William Mallard and Stephen Coates)

A year on from first lockdown, Britain grieves for COVID-19 dead

By Estelle Shirbon

LONDON (Reuters) – A year to the day after they were first ordered to stay at home to contain the spread of COVID-19, Britons on Tuesday remembered more than 126,000 people who lost their lives to the disease, a toll few people could have imagined in March 2020.

At midday (1200 GMT), people in parliament, hospitals, churches, public places and offices – still mostly empty with millions working at home due to social distancing rules – fell silent for a minute to honor the dead.

People were also being invited to stand on their doorsteps at 8 p.m. holding candles or torches.

Official data show that on March 23, 2020, when Prime Minister Boris Johnson stunned the nation by ordering people to stay at home and shutting down much of the economy, fewer than 1,000 Britons had succumbed to the novel coronavirus.

The number of people known to have died in the United Kingdom within 28 days of testing positive for COVID-19 now stands at 126,172, the worst toll in Europe and fifth highest in the world.

Johnson, who was himself very ill with COVID-19 in April 2020 and spent three nights in intensive care, opened Tuesday’s cabinet meeting by reflecting on “a very dark and difficult year” for Britain, his Downing Street office said.

Johnson told ministers the nation was mourning for those who have died, and he paid tribute to health and care workers and to society as a whole for keeping the country going.

Queen Elizabeth marked the anniversary by sending spring flowers to St. Bartholomew’s Hospital in London. Her husband, 99-year-old Prince Philip, underwent a heart procedure there earlier this month.

“As we look forward to a brighter future together, today we pause to reflect on the grief and loss that continues to be felt by so many people and families,” she said in a message.

HEARTS TO REMEMBER

In the evening, landmarks across the United Kingdom, from the London Eye, Trafalgar Square and Wembley Stadium to Cardiff Castle and Belfast City Hall will be lit up in yellow as a beacon of hope and support for the bereaved.

At Kew Gardens, the world-renowned botanical gardens in west London, two heart-shaped flower beds made up of yellow tulips, hyacinths and polyanthus were on display, in solidarity with the Yellow Hearts to Remember campaign to support the bereaved.

The past year has tested the country with repeated lockdowns, forced separation on families and friends and months of home schooling on millions of children and left industries fighting for survival.

After a second national lockdown kept people shut up in their homes through much of the winter, Britain is gradually easing restrictions under a four-step plan underpinned by the success of the national vaccination campaign.

Close to 28 million people have received at least one dose of a COVID-19 vaccine, offering hope of a gradual return to normality.

Johnson paid tribute to scientists, saying he would not have believed 12 months ago that within a year vaccines would have been developed and half Britain’s adult population would have received at least one dose.

For now, however, life remains far from normal.

During rush hour, a small number of London commuters – all wearing face masks – had space to sit down on their way to work, where before the pandemic thousands of people would have been crammed together.

“It’s been a struggle, I’m not going to lie,” said Londoner Tom Johnson on his commute.

“We can sort of see a light at the end of the tunnel now,” he added. “I think we’re quite a strong, resilient sort of country, and I reckon we’ll come back flying.”

(Additional reporting by Toby Melville and Ben Makori; editing by Ed Osmond and Mike Collett-White)

Mexico to tighten borders against COVID-19 as U.S. offers vaccine help

MEXICO CITY (Reuters) – Mexico’s government said on Thursday it would apply travel curbs on its southern border with Guatemala to help contain the spread of COVID-19 as officials said the Biden administration planned to loan Mexico vaccines to fight the pandemic.

The foreign ministry’s announcement that Mexico would restrict movement on its border with Guatemala comes just as the country plans to step up enforcement efforts in the area against illegal immigration, according to a Reuters report.

President Joe Biden is under increasing pressure to reduce a recent surge in migrants from Central America reaching the U.S. border while Mexico has been pressing the U.S. government for a loan of vaccines to help its drive to tackle COVID-19.

A U.S. congressional source said the mutually beneficial news on the vaccines and the border curbs was no coincidence. A Mexican official did not immediately reply to a request for comment on whether the two announcements were linked.

Confirming details reported by Reuters, Mexican Foreign Minister Marcelo Ebrard said that Mexico and the United States were crafting a deal for 2.5 million doses of AstraZeneca’s COVID-19 vaccine and that he would reveal more on Friday.

“This would be the best start for a broad cooperation on vaccines,” Ebrard said on Twitter.

A U.S. official told Reuters that under the loan deal, the United States would send Mexico 2.5 million doses of the AstraZeneca vaccine that it is not using. Canada is also set to receive 1.5 million doses under the arrangement.

In a statement, Mexico’s foreign ministry said restrictions for non-essential activities on its borders with the United States and Guatemala would take effect starting on Friday, and would remain in place until midnight of April 21.

During the past few months, Mexico had announced extensions to restrictions along its border with the United States as part of bilateral efforts to stem the spread of the pandemic.

Those monthly communiques did not mention the border with Guatemala, where average COVID-19 cases are now lower than they were in January, though they have been ticking up.

Mexico’s own infections have fallen sharply in the last few weeks, and the two southern states covering over 85% of the border with Guatemala are two of only three in the country at the lowest COVID-19 alert level, health ministry data show.

Mexico has 31 states.

(Reporting by Diego Ore and Dave Graham in Mexico City and Jeff Mason in Washington; Writing by Laura Gottesdiener; Editing by Andrea Ricci)

EU drugs regulator clears J&J’s single-shot COVID-19 vaccine

By Muvija M and Pushkala Aripaka

(Reuters) – The European Union’s drugs regulator on Thursday approved Johnson & Johnson’s single dose COVID-19 vaccine, as the bloc seeks to speed up a stuttering inoculation campaign and boost its supplies.

The COVID-19 shot is the fourth to be endorsed for use in the EU after vaccines from Pfizer-BioNTech, AstraZeneca-Oxford University and Moderna, and is recommended for those over 18 years of age, the European Medicines agency (EMA) said. It’s the first single-dose shot.

The United States, Canada and Bahrain have also approved the shot. South Africa is carrying out an expedited review.

“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” EMA’s Executive Director Emer Cooke said.

Final approval by the European Commission is expected soon. EU conditional marketing authorization allows a treatment to be sold for a year without full data on its efficacy and side-effects being available.

The region is having difficulty taming a spike in cases driven by a more contagious variant of the coronavirus, with countries including Italy and France imposing fresh lockdowns.

J&J chief scientific officer Paul Stoffels described it as a “landmark moment” for the U.S. drugmaker and the world as governments struggle to control the pandemic which has crushed economies and killed more than 2.7 million.

The shot, called COVID Vaccine Janssen after the J&J unit that developed it, will help bulk up EU vaccine supplies after a faltering rollout due to delivery delays from Pfizer and AstraZeneca.

J&J has agreed to deliver at least 200 million doses to the EU this year, including 55 million in the second quarter, with the first shipments expected next month.

Exact volumes are not clear though and the U.S. drugmaker has told the European Union it is facing supply issues that may complicate plans to deliver the second quarter doses in full.

The news came as Norway and Denmark temporarily suspended the use of AstraZeneca’s vaccine after reports of the formation of blood clots in some who have been vaccinated.

TRIAL DATA

In J&J’s 44,000-person global trial, the vaccine was found to be 66% effective at preventing moderate-to-severe COVID-19 four weeks after inoculation. It was 100% effective in preventing hospitalization and death due to the virus.

In its statement on Thursday, the EMA said the vaccine was found to be 67% effective two weeks after inoculation.

The side effects were usually mild or moderate and cleared within a couple of days after vaccination, it said. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea.

Though many rival shots have reported a higher protection rate, J&J’s vaccine could help boost thin EU supplies and simplify inoculation campaigns because it does not require a second dose or need to be shipped frozen.

Direct comparison between headline numbers reported by different drugmakers is difficult because their trials had different goals, and J&J’s study was conducted while new, more contagious variants of the virus were circulating.

Its vaccine delivers immunity-building proteins through a weakened version of a common cold virus, similar to AstraZeneca’s shot. J&J has also used the technology in its EU-approved Ebola vaccine.

(Reporting by Muvija M and Pushkala Aripaka in Bengaluru; additional reporting by Francesco Guarascio in Brussels and Bart Meijer in Amsterdam; Editing by Josephine Mason, Mark Potter and Kevin Liffey)

Exclusive: Oxford study indicates AstraZeneca effective against Brazil variant, source says

By Rodrigo Viga Gaier

RIO DE JANEIRO (Reuters) – Preliminary data from a study conducted at the University of Oxford indicates that the COVID-19 vaccine developed by AstraZeneca PLC is effective against the P1, or Brazilian, variant, a source with knowledge of the study told Reuters on Friday.

The data indicates that the vaccine will not need to be modified in order to protect against the variant, which is believed to have originated in the Amazonian city of Manaus, said the source, who requested anonymity as the results have not yet been made public.

The source did not provide the exact efficacy of the vaccine against the variant. They said the full results of the study should be released soon, possibly in March.

Early results indicated the AstraZeneca vaccine was less effective against the South African variant, which is similar to P1. South Africa subsequently paused the use of the vaccine in the country.

The information comes as a small-sample study suggested the COVID-19 vaccine developed by China’s Sinovac may not work effectively against the Brazilian variant.

Responding to a request for comment, Fiocruz, which sent the samples that formed the basis of the study, told Reuters it did not have any information on the study, as it was being led by AstraZeneca and the University of Oxford.

Representatives for AstraZeneca and the University of Oxford did not immediately respond to requests for comment.

Brazil is currently confronting a brutal and long-lasting second wave of the coronavirus, hitting a daily record of 1,910 deaths on Wednesday.

The P1 variant is among the factors that epidemiologists believe is contributing to a rise in cases and deaths, and there has been concern in the scientific community about the variant’s resistance to vaccines.

(Reporting by Rodrigo Viga Gaier; Writing by Gram Slattery; Editing by Hugh Lawson)

Kenya hails first vaccine ‘bazookas,’ Rwanda secures Pfizer shots

By Omar Mohammed and Clement Uwiringiyimana

NAIROBI/KIGALI (Reuters) – Kenya received over a million doses of the AstraZeneca COVID-19 vaccine on Wednesday, while Rwanda said it was the first in Africa to secure shots from Pfizer, as efforts to inoculate the world’s poorest nations accelerated.

With fewer resources and tougher logistics than other regions, African nations are racing to secure the doses needed to protect their roughly 1.3 billion people and allow the safe reopening of economies.

Africa has been relatively lightly hit by the coronavirus compared with other regions, recording 104,000 deaths, according to a Reuters tally. That is lower than national tolls in the United States, India, Brazil, Russia and Britain.

Kenya’s batch, which arrived on a Qatar Airways passenger flight, is the first of an initial allocation of 3.56 million doses by the global COVAX facility.

“We have received … machine guns, bazookas, and tanks to fight this war against COVID-19,” Health Minister Mutahi Kagwe exulted as the doses arrived at Nairobi’s main airport.

COVAX, which is led by the GAVI vaccines alliance along with the World Health Organization (WHO) and other partners, aims to deliver over 1.3 billion doses to 92 lower- and middle-income countries, covering up to 20% of their populations.

Backers of the initiative hope to level a playing field that has seen wealthier nations quickly vaccinate millions, ahead of poorer regions. Only a few African nations have started inoculating citizens with vaccines acquired outside of COVAX.

First shots under COVAX are arriving at several African nations this week, including Nigeria, Senegal and Uganda.

Senegal, which received 200,000 doses developed by China’s Sinopharm last month, got an additional 324,000 shots of the AstraZeneca vaccine on Wednesday, via COVAX.

COLD STORAGE

In Kigali, officials said Rwanda will get the first doses of the Pfizer COVID-19 shots to be dispatched to Africa under the vaccine-sharing scheme. The Pfizer vaccine presents an extra logistical challenge because it requires ultra-cold storage.

The batch of 102,960 doses were due in Kigali on Wednesday, hours after a flight landed carrying 240,000 AstraZeneca doses from the Serum Institute of India, the health ministry said. The government has installed special infrastructure to keep the vaccine at -70 degrees.

“Rwanda is one of the first countries among the low income countries to have ultra-cold chain,” said Fode Ndiaye, the United Nations’ resident coordinator.

Rwanda plans to start its vaccination drive on Friday, prioritizing frontline health workers and others at high risk. It hopes to vaccinate 30% of its roughly 12 million people before the end of this year.

Despite Africa’s comparatively low fatalities, fragile economies across the continent are reeling from lockdowns.

Kenya, which has so far recorded 106,470 infections and 1,863 deaths, has taken a major economic hit from the virus, which cut the flow of tourists, a crucial source of foreign exchange and jobs.

Nairobi plans to prioritize 400,000 health workers nationwide in a vaccination campaign starting on Friday, the health ministry said.

It will join Ivory Coast, Ghana and South Africa among the nations in sub-Saharan Africa to start vaccination drives.

(Writing by Duncan Miriri; Editing by Andrew Cawthorne)

New WTO chief calls for tripling of vaccine production

By Emma Farge and Philip Blenkinsop

GENEVA (Reuters) – The new chief of the World Trade Organization (WTO) urged its member states on Monday to work with pharmaceutical companies to license more COVID-19 vaccine manufacturing in developing countries in order to triple global production.

“People are dying in poor countries,” Ngozi Okonjo-Iweala said on her first day in office. “The world has a normal capacity of production of 3.5 billion doses of vaccines and we now seek to manufacture 10 billion doses.”

Her call comes as a group of developing countries led by South Africa and India seek to waive intellectual property rights for COVID-19 drugs and vaccines, a move opposed by the United States, the European Union and other wealthy nations.

Okonjo-Iweala, the WTO’s first female and first African director-general, said that, while this debate continued, companies must be encouraged to open up and license more viable manufacturing sites now in developing countries.

In a speech to the WTO’s 164 member states, she said there was an upcoming world manufacturing convention and urged the start of dialogue with manufacturers associations.

After a long campaign that was derailed in the latter stages by a Trump administration veto, the 66-year-old Nigerian was confirmed as boss last month, pledging to “forget business as usual” at the WTO, which is struggling to strike new deals and whose arbitration functions are paralyzed.

“READY TO GO”

“It feels great. I am coming into one of the most important institutions in the world and we have a lot of work to do. I feel ready to go,” Okonjo-Iweala told a reporter on arrival at the WTO’s lakeside Geneva headquarters where she donned a mask and elbow-bumped officials.

The former Nigerian finance and foreign minister aims to revive the global trade watchdog ahead of a major year-end meeting, saying she feared the world was leaving the WTO behind.

WTO delegates agreed to hold the next major ministerial conference in Geneva from Nov. 29.

The meeting was originally due to be held in Kazakhstan in 2020 but was delayed due to the pandemic. Okonjo-Iweala has said she hopes ministers at the year-end meeting can finalize deals on ending fisheries subsidies and reforms for the WTO’s top appeals body.

Since the WTO director-general holds few executive powers, some analysts question her ability to revive the body in the face of so many challenges, including persistent U.S.-China trade tensions and growing protectionism heightened by the pandemic.

(Reporting by Emma Farge and Philip Blenkinsop in Brussels; editing by Ed Osmond and Gareth Jones)

FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

By Manas Mishra and Michael Erman

(Reuters) – A panel of expert advisers to the U.S. Food and Drug Administration began a meeting to discuss Johnson & Johnson’s one-dose COVID-19 vaccine on Friday, setting the stage for a possible emergency use authorization as early as this week.

After it receives the recommendation, the FDA is likely to authorize the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

The panel, consisting of doctors, infectious disease experts and medical researchers, began the meeting at 9:00 a.m. ET (1400 GMT), and will vote in favor or against the vaccine’s use several hours later at the end of the meeting.

The panel will consider whether the benefits of the vaccine outweigh its risk for use in people aged 18 and older.

In a 44,000-person trial, the vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

The effectiveness of the one-dose vaccine varied over time and location. In the United States, the effectiveness was 74% at 14 days and 72% two weeks later, while the shot was 64% effective at stopping moderate-to-severe COVID-19 after 28 days in South Africa, where a worrying new variant has swept across the country.

The vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

“In the context of the pandemic, the FDA is likely to issue an emergency use authorization (EUA) based on the data,” said UBS analyst Navin Jacob ahead of the panel meeting.

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than that of the Pfizer Inc/BioNTech SE and Moderna Inc vaccines that use mRNA technology and must be shipped and stored frozen.

J&J’s vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Three to four million doses of the vaccine are expected to be rolled out next week.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New York; Editing by Caroline Humer, Bill Berkrot and Shounak Dasgupta)

Indian vaccine makers say can quickly adapt to tackle variants

By Krishna N. Das and Neha Arora

NEW DELHI (Reuters) – Indian pharmaceutical companies Bharat Biotech and Biological E. Ltd said on Monday they could quickly rework their COVID-19 vaccine products to fight new variants once their genetic sequence is known.

In recent months, India has confirmed the presence of the variants first identified in Brazil, Britain and South Africa, which are believed to explain an upsurge in cases in the Indian states of Maharashtra and Kerala.

In all, India has reported more than 11 million coronavirus infections, the highest number in the world after the United States, and about 156,000 deaths.

“As we are seeing a lot of resurgence of cases, we are picking up samples from hotspots and clusters and we are trying to sequence them,” Nivedita Gupta, deputy director-general of the state-run Indian Council of Medical Research (ICMR), told the BioAsia conference.

ICMR and Bharat Biotech have collaborated to develop India’s first homegrown COVID-19 vaccine, which, along with another licensed from AstraZeneca and Oxford University, is being used in the country’s immunization campaign that has covered more than 10 million people since mid-January.

India is the world’s biggest maker of vaccines, and its companies have promised to produce billions of doses of COVID-19 shots.

Bharat Biotech Chairman Krishna Ella said his company would mainly need data from the ICMR or the World Health Organization on the genetic sequence of any variant to quickly make an effective vaccine.

Speaking at a conference organized by the state of Telangana, home to India’s vaccine hub Hyderabad, Ella said a product to tackle the South African variant could be made in 15 days and would not require any change to the manufacturing process.

Biological E. Managing Director Mahima Datla said there was no need to be “overly concerned” about the mutations.

“Eventually we don’t know which variant of the virus, which mutants will take over, but we think that it’s prudent to work on technologies that address the new variants as well,” she said.

Biological E., which is developing a vaccine with Houston’s Baylor College of Medicine and Dynavax Technologies, recently completed Phase 1/2 clinical trial in India, Datla said.

Its product uses the recombinant-protein technology in which a harmless agent is used to stimulate an immune response in cells.

“Once you know the variant, when it’s sequenced, it is fairly quick to deploy into a vaccine,” said Datla, whose company will also contract-manufacture Johnson & Johnson’s shot.

(Reporting by Krishna N. Das and Neha Arora; editing by Barbara Lewis)