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)

Africa COVID-19 deaths surpass 100,000 after second wave

JOHANNESBURG (Reuters) – Africa’s reported COVID-19 death toll surpassed 100,000 on Friday, a fraction of those reported on other continents but rising fast as a second wave of infections overwhelms hospitals.

The continent’s reported deaths, at 100,354, compare favorably with North America, which has registered more than half a million, and Europe, which is approaching 900,000, a Reuters tally shows.

But deaths are rising sharply across Africa, driven by its southern region, especially economic powerhouse South Africa, which accounts for nearly half. South Africa was ravaged by a second wave caused by a more contagious variant that has jammed up casualty wards.

“The increased number (of infections) has led to many severe cases and some of the countries really found it quite difficult to cope,” Richard Mihigo, coordinator of the immunization program at the World Health Organization’s Africa office, told Reuters.

“We have seen some countries getting to their limit in terms of oxygen supply, which has got a really negative impact in terms of case management for severe cases.”

Mihigo said the rise in deaths was pronounced in countries near South Africa like Zimbabwe, Mozambique and Malawi, raising the possibility that the 501Y.V2 variant identified in South Africa late last year had spread through the southern Africa region – although more genomic sequencing needs to be carried out to prove that.

International aid group Doctors Without Borders (MSF) this month called for urgent vaccine distributions in southern Africa to counter the spread of the new variant, as most African countries have lagged richer Western nations in launching mass vaccination programs.

Reuters data show Africa’s case fatality rate is now at around 2.6%, higher than the global average of 2.3%, and marginally up on the 2.4% rate after the first wave of infections – which at the time compared favorably with other continents.

Experts caution against reading too much into the data – the real toll may be much higher or lower. For instance, South Africa’s excess deaths – deaths considered over-and-above the normal rate – during the pandemic have reached over 137,000, almost three times its official COVID-19 death toll.

Then again, in some cases Africa’s low testing rates could inflate its true case fatality rate (CFR), said Professor Francisca Mutapi, an infectious disease expert at the University of Edinburgh.

“If deaths being registered as COVID-19 deaths are not necessarily contingent on a positive test … as is the case in South Africa, then this can drive up CFR,” she said.

Even with these caveats acknowledged, African countries look like they are struggling with COVID-19 more than last year.

“Are we counting all the deaths on the continent? No … but most people on the continent do know somebody who has died of COVID during this second wave,” Africa CDC director John Nkengasong told reporters last week.

“Hospitals are being overwhelmed due to health systems that are fragile.”

(Reporting by Alexander Winning, Tim Cocks and Wendell Roelf; Writing by Tim Cocks; Editing by Nick Macfie, Angus MacSwan and Jane Wardell)

Shops boarded up as Dutch brace for fourth night of coronavirus riots

By Anthony Deutsch

AMSTERDAM (Reuters) – The Netherlands braced on Tuesday for a fourth consecutive night of coronavirus anti-lockdown riots, with some shops boarding their windows and sending staff home early for safety.

Dutch police detained more than 180 people on Monday night, where roaming groups set fires, threw rocks and looted stores in several cities.

The Netherlands’ first curfew since World War Two was imposed on Saturday despite weeks of falling infections, after the National Institute for Health (RIVM) said a faster-spreading variant first found in England was causing a third of cases.

A hospital in Rotterdam warned visitors of patients to stay away, after rioters tried to attack hospitals in various cities in the past days.

“We have had riots in the past, but it’s rare to have this for several nights across the entire country,” said National Police spokeswoman Suzanne van de Graaf. “It’s not only in known problem areas, but much more widespread.”

Riot police with shields and batons were called out in more than 10 cities, many of which had issued emergency decrees to provide officers with greater powers to conduct searches.

Police had scuffled with rioters in several cities late into the night, chasing them down narrow streets with vans or on foot as helicopters hovered overhead.

In Amsterdam on Monday, groups of youths threw fireworks, broke store windows and attacked a police truck, but were broken up by a massive police presence.

Ten police officers were injured in Rotterdam, where 60 rioters were detained overnight after widespread looting and destruction in the city center, a police spokeswoman said. Supermarkets in the port city were emptied, while rubbish bins and vehicles were set ablaze.

Two photographers were hurt after being targeted by rock-throwing gangs, one in Amsterdam and another in the nearby town of Haarlem, police said.

Coronavirus infections have been falling in recent weeks, with the number of new cases down by 8% over the past week. A little under 4,000 new infections were reported on Tuesday, the smallest daily increase since Nov 24.

But the RIVM said the situation in the Netherlands was still very serious as a result of the more contagious variant that has caused a massive surge in cases in Britain.

Van de Graaf said much of the aggression during the three days of unrest had been targeted at police officers. More than 470 people have been arrested, with riot police deploying water cannon and officers on horseback in several places.

Schools and non-essential shops across the Netherlands have been shut since mid-December. Bars and restaurants were closed two months earlier. The country’s death toll stands at 13,664, with 956,867 infections to date.

(Reporting by Anthony Deutsch; Editing by Clarence Fernandez, Catherine Evans and Peter Graff)