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)

WHO lists AstraZeneca/Oxford COVID-19 vaccine for emergency use

GENEVA (Reuters) – The World Health Organization (WHO) on Monday listed AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use, widening access to the relatively inexpensive shot in the developing world.

A WHO statement said it had approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.

“We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production,” said Tedros Adhanom Ghebreyesus, WHO Director-General.

The listing by the UN health agency comes days after a WHO panel provided interim recommendations on the vaccine, saying two doses with an interval of around 8 to 12 weeks must be given to all adults, and can be used in countries with the South African variant of the coronavirus as well.

The AstraZeneca/Oxford shot has been hailed because it is cheaper and easier to distribute than some rivals, including Pfizer/BioNTech’s, which was listed for emergency use by the WHO late in December.

Nearly 109 million people have been reported to be infected by the novel coronavirus globally and more than 2.5 million have died, according to a Reuters tally.

Infections have been reported in more than 210 countries and territories since the first cases were identified in China in December 2019.

(Reporting by John Revill, John Miller, Michael Shields in Zurich, Kate Kelland in London, Editing by William Maclean)

62.9 million doses of COVID-19 vaccines delivered, 43.2 million administered: U.S. CDC

Reuters) – The U.S. Centers for Disease Control and Prevention said it had administered 43,206,190 doses of COVID-19 vaccines in the country as of Tuesday morning and delivered 62,898,775 doses.

The tally of vaccine doses are for both Moderna and Pfizer/BioNTech vaccines as of 6:00 a.m. ET on Tuesday, the agency said.

The agency said 32,867,213 people had received 1 or more doses while 9,840,429 people have got the second dose as of Tuesday.

A total of 5,015,224 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Aditya Soni)

Fauci says vaccinate quickly to fight COVID-19 variants

(Reuters) – The best defense against the evolution of COVID-19 and the emergence of variant strains is getting as many people vaccinated as quickly as possible, top U.S. infectious disease doctor Anthony Fauci said on a Monday media briefing.

Fauci said while it was reasonable to think about studying the efficacy of Pfizer’s and Moderna’s vaccine as a one-dose regimen in light of supply vaccine constraints, such a study would take months to complete, thus likely making its conclusions moot. Fauci continued to encourage people get two doses of the vaccine.

(Reporting by Carl O’Donnell, Editing by Franklin Paul)

White House says it is working to speed early production of J&J COVID-19 vaccine

By Dania Nadeem, Rebecca Spalding and Julie Steenhuysen

(Reuters) – The Biden administration is exploring every option for increasing manufacturing of Johnson & Johnson’s COVID-19 vaccine, which is under regulatory review, and said on Friday that currently expected levels of early doses were less than hoped.

The White House has invoked the Defense Production Act to help Pfizer Inc ramp up COVID-19 vaccine production and that “every option” was on the table to produce more Johnson & Johnson vaccine should it be authorized.

It will also use the wartime powers to increase at-home COVID-19 tests, and make more surgical gloves in the United States, officials said at a Friday media briefing.

“As is the case with other vaccines, we have not found that the level of manufacturing allows us to have as much vaccine as we think we need coming out of the gate,” said Andy Slavitt, senior adviser to the White House’s COVID-19 response team, referring to the J&J vaccine.

J&J applied on Thursday for U.S. emergency use authorization. It expects to have some vaccine ready for distribution as soon as authorized but has not said how much.

Emergent Biosolutions’ Chief Executive Robert Kramer said in an interview on Friday that the company currently is making bulk drug substance for J&J “at large scale.” Emergent is only producing bulk vaccine, which is then filled into syringes or vials and packaged for shipment by another contractor.

Kramer said they were on track to make enough product for hundreds of millions of doses a year. It remains unclear what other supply bottlenecks may be. Kramer said his company had already benefited from the Defense Production Act under the Trump Administration, which helped the company get to the point where it’s ready to go.

Under the authority of the Defense Production Act, the government will give priority ratings to two components important to Pfizer’s vaccine production – filling pumps and tangential flow filtration units, the officials said.

“We told you that when we heard of a bottleneck on needed equipment, supplies, or technology related to vaccine supply that we would step in and help, and we were doing just that,” said Tim Manning, the supply chain coordinator for the national COVID-19 response.

The government will also invoke its powers under the Defense Production Act to increase at-home COVID-19 tests with six, unnamed manufacturers, aiming to produce 61 million tests by the summer, Manning said.

It will also invoke its powers to increase the nation’s supply of surgical gloves, which are made almost exclusively overseas.

Manning said the government will build factories that make the raw materials for surgical gloves and help build plants in the United States to make the gloves.

By the end of the year, he said, the United States would be able to produce a billion gloves a month.

Officials have said that once J&J’s vaccine is authorized, it would mean that millions more doses would be available to states. The vaccine is one-shot, as opposed to Pfizer’s and Moderna Inc’s two-dose vaccines, and can be stored in a refrigerator.

Officials have hoped that the ease of giving the J&J vaccine will mean that states will be able to more quickly immunize residents.

(Reporting by Dania Nadeem, Rebecca Spalding and Julie Steenhuysen, Editing by Peter Henderson, Steve Orlofsky and David Gregorio)

J&J adds to COVID-19 vaccine armory with 66% efficacy in global trial

By Julie Steenhuysen

(Reuters) – Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus.

In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread.

A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses.

Those trials, however, were conducted mainly in the United States and before new variants emerged.

The top U.S. infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging.

“It’s really a wake up call for us to be nimble and to be able to adjust as this virus will continue for certain to evolve,” Fauci said.

J&J’s main goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization across all geographies and against multiple variants 28 days after immunization.

That “will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19,” Paul Stoffels, J&J’s chief scientific officer, said of the results, which were based on 468 symptomatic cases.

SEEKING APPROVAL

J&J plans to seek emergency use authorization from the U.S. Food and Drug Administration next week. It has said it plans to deliver 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.

Public health officials are counting on the J&J vaccine to increase much-needed supply and simplify immunization in the United States, which has a deal to buy 100 million doses of J&J’s vaccine and an option for an additional 200 million.

J&J said the vaccine would be ready immediately upon emergency approval, but Stoffels declined to say how many doses.

“Right now, any protection and additional vaccine is great. The key is not only overall efficacy but specifically efficacy against severe disease, hospitalization, and death,” Walid Gellad, a health policy associate professor at the University of Pittsburgh, said.

Michael Breen, Director of Infectious Diseases and Ophthalmology at research firm GlobalData said “Most countries are still desperate to get their hands on doses, regardless of whether or not the vaccine is considered highly effective. Moderately effective will do just fine for now.”

None of the vaccine recipients in the J&J trial died from COVID-19, compared with 5 in the placebo group, the National Institutes of Health said. Three deaths in the vaccine group overall, but none were determined to be from the virus. That compares with 16 deaths overall in the placebo arm, it added.

Unlike the Pfizer and Moderna vaccines, J&J’s does not require a second shot weeks after the first or need to be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are an issue.

SOUTH AFRICAN VARIANT

Several studies have emerged this month showing that a South African variant has mutated in areas of the virus that are key targets of vaccines, reducing their efficacy.

“What we are learning is there is different efficacy in different parts of the world,” Stoffels told Reuters.

In a sub-study of 6,000 volunteers in South Africa, Stoffels said, the J&J vaccine was 89% effective at preventing severe disease. In the South Africa portion of the trial, 95% of cases were infections with the South African variant.

“I am overwhelmed by the fact that this vaccine protected against severe disease even in South Africa,” said Glenda Gray, the joint lead investigator of the South African vaccine trial.

Gray, who is the chief executive of the South African Medical Research Council, said this is by far the best vaccine for South Africa to fight the mutant strain and can prevent a large number of hospitalizations and deaths.

A mid-stage trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy, proving to be 60% effective among volunteers who didn’t have HIV. In a separate, late-stage trial in Britain it was 89.3% effective.

In the J&J trial, which was conducted in eight countries, 44% of participants were from the United States, 41% from Central and South America and 15% from South Africa. Slightly more than a third of the volunteers were over 60.

J&J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells in the body and trigger an immune response, whereas the Pfizer/BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).

(Reporting by Julie Steenhuysen; Additional reporting by Manas Mishra, Dania Nadeem and Manojna Maddipatla in Bengalaru and Rebecca Spalding and Michael Erman in New York; Writing by Alexander Smith; Editing by Caroline Humer, Peter Henderson, Edwina Gibbs and Keith Weir)

EU warns it could block vaccine exports, wields legal threat at drugmakers

By John Chalmers and Philip Blenkinsop

BRUSSELS (Reuters) – Europe’s fight to secure COVID-19 vaccine supplies intensified on Thursday when the European Union warned drug companies such as AstraZeneca that it would use all legal means or even block exports unless they agreed to deliver shots as promised.

The EU, whose member states are far behind Israel, the United Kingdom and the United States in rolling out vaccines, is scrambling to get supplies just as the West’s biggest drugmakers slow deliveries to the bloc due to production problems.

As vaccination centers in Germany, France and Spain cancelled or delayed appointments, the EU publicly rebuked Anglo-Swedish drugmaker AstraZeneca for failing to deliver and even asked if it could divert supplies from Britain.

European Council President Charles Michel said in a letter to four EU leaders that the EU should explore legal means to ensure supplies of COVID-19 vaccines it contracted to buy if negotiations with companies over delayed deliveries are unsuccessful.

“If no satisfactory solution can be found, I believe we should explore all options and make use of all legal means and enforcement measures at our disposal under the Treaties,” Michel said in the Jan. 27 letter.

EU rules on monitoring and authorizing exports of COVID-19 vaccines in the 27-nation bloc could lead to exports being blocked if they violated existing contracts between the vaccine maker and the EU, an EU official said.

The European Commission is to lay out the criteria under which such exports would be evaluated on Friday.

VACCINE CRUNCH

The swiftest mass vaccination drive in history is stoking tensions across the world as big powers buy up doses in bulk and poorer nations try to navigate a financial and diplomatic minefield to collect whatever supplies are left.

Israel is by far the world leader on vaccine rollout per head of population, followed by the United Arab Emirates, the United Kingdom, Bahrain and the United States. Behind them are Italy, Germany, France, China and Russia.

The African Union (AU) has secured another 400 million doses of the AstraZeneca COVID-19 vaccine, a regional health leader said on Thursday, in a push to immunize 60% of the continent’s population over three years.

Under fire from the EU, AstraZeneca CEO Pascal Soriot said the EU was late to strike a supply contract so the company did not have enough time to iron out production problems at a vaccine factory run by a partner in Belgium.

Tensions have risen as both New York-based Pfizer and AstraZeneca, headquartered in Cambridge, England, have had production problems.

Britain, which has repeatedly touted its lead in the vaccine rollout race since leaving the EU’s orbit on Jan. 1, said its deliveries must be honored.

“I think we need to make sure that the vaccine supply that has been bought and paid for, procured for those in the UK, is delivered,” Minister for the Cabinet Office Michael Gove told LBC Radio.

Just a day ahead of a decision by European regulators on whether to approve the drugmaker’s shot, Germany’s vaccine committee said AstraZeneca’s vaccine should only be given to people aged between 18 and 64.

“There are currently insufficient data available to assess the vaccine efficacy from 65 years of age,” the committee, also known as Stiko, said in a draft resolution made available by the health ministry on Thursday.

Britain’s Johnson said health authorities in Britain believed the vaccine was safe and worked across all age groups.

APPOINTMENTS CANCELLED

In the northern French region of Hauts-de-France, France’s second-most-densely-populated region, several vaccination centers were no longer taking appointments for a first jab. In several other French regions, some online appointment platforms closed booking options.

Spain’s Madrid region has ceased first vaccinations for at least this week and next and was using the few doses it has to administer second shots to those who have had the first one, said deputy regional government chief Ignacio Aguado.

Germany’s most populous state, North Rhine-Westphalia, last week postponed opening its vaccination centers until Feb. 8, while the state of Brandenburg has also had to push back vaccination appointments originally scheduled for the end of January due to delivery delays.

AstraZeneca is prepared to publish the delivery contract it has with the European Union and aims on Friday to make proposals to the European Commission on which sensitive parts to black out, the Frankfurter Allgemeine reported.

The newspaper quoted an EU source as saying that while AstraZeneca would not be able to deliver the 80 million doses expected for the first quarter, volumes should significantly exceed the 31 million doses that had earlier been reported.

(Reporting by Emma Thomasson and Paul Carrel in Berlin and Matthias Blamont in Paris and Kate Holton, Paul Sandle and Alistair Smout in London; writing by Guy Faulconbridge; editing by Keith Weir and Nick Macfie)

Madrid halting COVID-19 vaccinations due to supply delays

MADRID (Reuters) – Delays to COVID-19 vaccine shipments have forced authorities in Madrid to halt inoculations and are threatening supplies in Catalonia, Spanish officials said on Wednesday.

The Madrid region has ceased first vaccinations for at least this week and next and was using the few doses it has to administer second shots to those who have had the first one, said deputy regional government chief Ignacio Aguado.

“We need more doses and we need them now,” he told reporters on Wednesday, urging newly appointed Health Minister Carolina Darias to act quickly to secure the shots.

U.S. pharmaceutical giant Pfizer said last week there would be a temporary slow down in shipments to the European Union in late January caused by changes to manufacturing processes to ultimately boost output.

The announcement angered some EU governments and the executive European Commission due to the slow pace of vaccine roll outs in the 27-nation bloc.

It is also in dispute with Anglo-Swedish pharmaceutical firm AstraZeneca, which developed its shot with Oxford University and notified the EU on Friday that it could not meet supply targets for the first quarter of the year.

Spain’s 14-day incidence of the virus hit a record 900 cases per 100,000 people on Wednesday and the Health Ministry reported 40,285 new infections and 492 deaths.

Officials in Madrid and Catalonia said at the current pace it would be impossible to reach the national target of 70% of Spain’s 47 million population vaccinated by July.

Catalan health secretary Josep Maria Argimon said the region would use up all its stockpile of vaccines in the coming days and will have to administer second shots later than planned due to supply delays, citing an undelivered shipment of the Moderna vaccine scheduled for this week as one example.

The affluent northeastern region will issue a new request for 30,000 vaccine doses that it expects to administer starting on Feb. 4, Argimon told a news briefing.

Spain has administered just over 1.3 million doses to a priority group of care-home residents and frontline medics, around 77% of its current stocks.

(Reporting by Inti Landauro, Emma Pinedo, Nathan Allen and Joan Faus; Editing by Mark Heinrich and Janet Lawrence)