The race is on to trace the new COVID-19 variant

By Alistair Smout, Francesco Guarascio and Chen Lin

LONDON/BRUSSELS/SINGAPORE (Reuters) – Governments around the world are urgently scouring databases for recent cases of COVID-19 infections, screening travelers and decoding the viral genomes of the new variant as they try to measure how far it has spread.

The pace of the work highlights the pressure on governments and public health authorities to decide quickly whether they need to take unpopular, economically damaging steps to curb Omicron’s spread.

Data shows it was circulating before it was officially identified in southern Africa last week and it has since been detected in more than a dozen countries. Work to establish if it is more infectious, deadly or evades vaccines will take weeks.

Britain and other major economies banned flights to and from southern Africa just days after the variant was first detected, roiling global financial markets and stirring worries about the economic damage.

The speed of the action is in stark contrast to the emergence of other variants – when the first samples of the Alpha variant were documented in Britain in September 2020, the government spent months gathering data and assessing its potential danger before imposing a nationwide lockdown in December.

It took the World Health Organization (WHO) months to designate it a variant of concern – its highest level.

Soon after detecting its first Omicron case on Friday, Israel announced it would buy 10 million more PCR kits that can detect the variant in an effort to contain its spread. It shut its borders to foreigners from all countries on Saturday.

Scotland and Singapore are scrambling to check tens of thousands of recent positive cases for signs of the variant they may have missed and the United States is enhancing its COVID-19 surveillance to distinguish domestic cases of the Omicron variant from the still-dominant Delta.

The European Union’s health commissioner has urged member states to boost efforts to detect mutations, as some still lag behind almost two years into the pandemic.

The bloc has now confirmed 42 cases in 10 countries.

“Certain Member States lag behind considerably in terms of this crucial dimension,” Stella Kyriakides said in a letter seen by Reuters to health ministers of the 27 EU countries.

“Already faced with a challenging winter due to the high transmissibility of the Delta variant (…) we may now experience further or additional pressures because of the appearance of the Omicron variant,” she wrote.

ALL ABOUT THE S-GENE

Most PCR tests cannot distinguish Omicron from the Delta variant, the dominant and most infectious version of the virus so far.

To distinguish Omicron from Delta, the PCR test must be able to identify a mutation in Omicron known as the S-gene drop-out or S-gene target failure (SGTF).

It is not a fail-safe because the Alpha variant, first identified in Britain, also has that mutation.

Given that Alpha is no longer widely circulating, the presence of the S-gene dropout suggests the sample is positive for Omicron and alerts the lab to send the sample for genome sequencing for confirmation.

If local PCR tests cannot identify this mutation, then randomly selected PCR swab samples must undergo genome sequencing, which can take up to a week.

The WHO has said that widely available tests are able to detect individuals infected with any variant, including Omicron.

However, it has so far only recommended the TaqPath test produced by U.S. firm Thermo Fisher as a proxy.

It’s not clear if countries will buy kits due to the unique characteristic of the test. Singapore is considering buying more, although no decision has yet been made, Kenneth Mak, the health ministry’s director of medical services, told Reuters.

Thermo Fisher has said it is prepared to increase production to meet demand from countries in Africa and elsewhere as they work to track the spread of the new variant.

Within a day of the variant being identified, Israel started checking for the S-Gene in all positive tests taken from travelers arriving at the main Ben Gurion airport, Israel’s head of public health at the Health Ministry, Sharon Alroy-Preis, told Parliament on Sunday.

Now, its labs monitor for that mutation in all tests nationwide and when a positive PCR test indicates SGTF, the sample is taken for further sequencing, the health ministry said.

Most U.S. labs will be using the TaqPath test, Scott Becker, chief executive of the Association of Public Health Laboratories (APHL), a network of state and municipal public health laboratories, told Reuters.

QUIRKS OF THE VARIANT

Out of the 150,000 positive tests going back a month assessed in Belgium, 47 had S-gene drop-out and a high viral load. Only one of them was Omicron, according to Marc Van Rast, one of the virologists who parsed the samples.

The Scottish authorities have gone through swabs back to Nov. 1 to help in discover nine cases of Omicron, all linked to the same event.

They have found that around Nov. 16, S-gene target failure had started appearing in the tests again, a week before South Africa and Botswana identified the new variant. That feature has helped to direct genomic sequencing, as it did when Alpha emerged.

“That is one of the quirks of this particular variant that we can use to our advantage,” Gregor Smith, Scotland’s chief medical officer, said on Monday.

It means the government can start estimating how prevalent the new variant may be, identify people who may need to get tested again and which samples need to be prioritized for further decoding in labs, Smith said.

“It’s the best method that we have to be able to identify cases at this point in time.”

(Reporting by Alistair Smout in London, Francesco Guarascio in Brussels, Chen Lin in Singapore, Julie Steenhuysen in Chicago and Maayan Lubell and Ari Rabinovitch in Jerusalem; Writing by Josephine Mason; Editing by Nick Macfie)

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)

France cranks up vaccine rollout to deliver shots faster

By Dominique Vidalon and Sudip Kar-Gupta

PARIS (Reuters) -France is stepping up its COVID-19 vaccine rollout by widening further its first target group to include more health workers and simplifying a cumbersome process to deliver jabs more quickly, Health Minister Olivier Veran said on Tuesday.

France’s inoculation campaign got off to a slow start, hampered in part by red tape and President Emmanuel Macron’s decision to tread warily in one of the most vaccine-skeptical countries in the world.

But France has fallen behind neighbors such as Britain and Germany, and the president is now demanding the vaccination program be expedited.

Veran told RTL radio that the government was going to “accelerate and simplify our vaccination strategy”.

Some 300 vaccination centers would be operational from next week, the minister said, after initially ruling out such centers.

The original plan had been for the first phase of the vaccine rollout, which began in France on Dec. 27, to focus on nursing home residents and their carers. By the end of the first week, France had delivered just over 500 COVID-19 shots.

Over the weekend, the first hospital staff began receiving the vaccine. The government has now added paramedics and health workers to the first target group.

By the end of January, France will have begun vaccinating people aged 75 and above who are living at home, Veran said.

The head of the union of pharmacies – whose ubiquitous network helps administer millions of flu jabs every year – urged the government to allow it to do the same for COVID-19 shots.

“If we only rely on vaccination centers, we can be sure the level of vaccination by June will be mediocre. That would be a disaster,” Gilles Bonnefond of the USPO pharmacists’ union told, Reuters in an interview. “We can be operational in a week.”

The coronavirus has claimed the lives of 65,415 people in France, the seventh-highest death toll in the world.

France received an initial 500,000 doses of the vaccine developed by Pfizer and Germany’s BioNTech and was due to receive an additional 500,000 per week. It will also get 500,000 doses per month of Moderna’s vaccine once it obtains regulatory approval in Europe and France.

MORE JABS

Rules demanding that only a doctor or a nurse under the direct supervision of a doctor inject the vaccine will be eased. Veran said a doctor would be allowed to supervise multiple nurses at any one time in a vaccination center.

Similarly, rules requiring that any person wanting a COVID-19 vaccine must hold a consultation with a doctor first would also be made simpler.

Veran also said about 10 to 15 cases of the new variant of the coronavirus first seen in Britain had been detected in France. Its rapid spread through southern England compelled British Prime Minister Boris Johnson to announce a third nationwide lockdown on Monday.

France remains under nightly curfew. Restaurants, bars, museums and cinemas are still closed. Veran said he hoped France would be able to open its ski resorts for the February holidays, but that such a move would depend on how active the virus was.

(Reporting by Dominique Vidalon, Sudip Kar-Gupta and Michel Rose; Writing by Richard Lough; Editing by Ed Osmond, Raissa Kasolowsky and Alex Richardson)