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Europe clears J&J’s single-shot COVID-19 vaccine as roll-out falters

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By Muvija M and Pushkala Aripaka

(Reuters) – Europe approved Johnson & Johnson‘s single dose COVID-19 vaccine on Thursday, paving the way for the first shots to be delivered in a month 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 European Union 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 COVID-19 vaccine.

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 after the agency gave its conditional approval.

The official nod came from the European Commission shortly after, the final step to allowing its use across the bloc.

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.

The first shipments will start in the second half of April, the company said, adding it is committed to delivering at least 200 million doses to the EU this year.

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 55 million doses due in the second quarter in full.

J&J’s factory in Leiden in the Netherlands and a plant in Baltimore in the United States run by Emergent BioSolutions have both been authorised by the drugs’ regulator as a manufacturer of ingredients for the vaccines.

Earlier this year, some EU countries raised questions about J&J’s production network and contract with the EU, which would require it to send vaccines made at the Dutch factory to the United States for bottling before being shipped back to the EU.

News that the EU had approved Johnson & Johnson’s vaccine 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 instructions for human cells to manufacture immunity-building proteins, using a weakened version of a common-cold virus to carry them in, similar to AstraZeneca’s shot, which uses a chimpanzee cold virus. J&J has also used the technology in its EU-approved Ebola vaccine.

EU conditional marketing authorisation allows a treatment to be sold for a year without full data on its efficacy and side-effects being available.

 

(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, Kevin Liffey and Susan Fenton)

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COVID cases in Ontario could spike to 30,000 per day by June

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TORONTO (Reuters) – New cases of COVID-19 in Canada‘s most populous province could rise more than six fold, topping 30,000 per day by early June if public health measures are weak and vaccination rates remain flat, a panel of experts advising the province of Ontario said on Friday.

Even if measures to control the virus are “moderate,” the number of patients in Ontario ICUs could reach 2,000 in May, up from 695 on Friday.

The College of Physicians and Surgeons of Ontario told doctors last week they may soon have to decide who can and cannot receive intensive care.

 

(Reporting by Allison Martell; Editing by Chris Reese)

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Moderna sees shortfall in Britain COVID vaccine shipments, EU deliveries on track

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ZURICH (Reuters) – U.S. drugmaker Moderna expects a shortfall in COVID-19 vaccine doses from its European supply chain hitting second-quarter delivery quantities for Britain and Canada, though European Union– and Swiss-bound shipments are on track, a spokesperson said.

The delays, first announced on Friday when Canada said Moderna would be delivering only about half the planned 1.2 million doses by the end of April, come as Switzerland’s Lonza ramps up three new production lines to make active ingredients for Moderna vaccine supplies outside of the United States.

“The trajectory of vaccine manufacturing ramp-up is not linear, and despite best efforts, there is a shortfall in previously estimated doses from the European supply chain,” Moderna said in a statement.

Lonza didn’t immediately return a phone call and email seeking comment on any issues in its production.

 

(Reporting by John Miller; editing by David Evans)

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Moderna says vaccines to Canada to be delayed due to Europe shortfall

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(Reuters) -Moderna Inc said on Friday a shortfall in COVID-19 vaccine doses from its European supply chain will lead to a delay in deliveries to some countries including Canada.

The drugmaker would be delivering only 650,000 doses by April end as opposed to 1.2 million, Canada‘s Procurement Minister Anita Anand said in a statement.

She said one to two million doses of the 12.3 million doses scheduled for delivery by Moderna in the second quarter would be delayed until the third.

Moderna officials in Europe did not immediately comment on the reason for the delays or give the total number of countries that would be impacted.

“Vaccine manufacturing is a highly complex process and a number of elements, including human and material resources have factored into this volatility,” said Patricia Gauthier, an executive at Moderna Canada.

Canada has distributed a total of 2.82 million doses of the Moderna vaccine as of April 14 and 12.7 million doses of COVID-19 vaccines in total.

Moderna has been aiming to deliver 700 million to 1 billion doses of the COVID-19 globally this year, including from plants in Europe and the United States.

Swiss contract drug manufacturer Lonza makes active ingredients for Moderna’s vaccine in Visp, but it was still ramping up three new production lines that once operational would be able to produce 300 million shots annually.

The current supply, demand and distribution landscape has led the drugmaker to make adjustments in the expected second-quarter deliveries, Gauthier said.

(Reporting by Manas Mishra in Bengaluru, Allison Martell in Toronto and John Miller in Zurich; Editing by Arun Koyyur)

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