Tag Archives: Vaccine

Moderna says possible allergic reactions to COVID-19 vaccine under investigation

(Reuters) – Moderna Inc said on Tuesday it had received a report from California’s health department that several people at a center in San Diego were treated for possible allergic reactions to its COVID-19 vaccine from a particular batch.

The company’s comments come after California’s top epidemiologist on Sunday issued a statement recommending providers pause vaccination from lot no. 41L20A due to possible allergic reactions that are under investigation.

“A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours,” the epidemiologist said in a statement.

The vaccine maker said it was unaware of comparable cases of adverse events from other vaccination centers which may have administered vaccines from the same lot or from other lots of its vaccine.

A total of 307,300 doses from the lot remain in storage, Moderna said, of the total 1,272,200 doses that were produced in the batch.

Moderna said it was working closely with U.S. health regulators to understand the cases and whether pausing the use of the lot was warranted.

Nearly a million doses from the lot have already been distributed to about 1,700 vaccination sites in 37 states, Moderna said.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Vinay Dwivedi and Shinjini Ganguli)

Brussels targets vaccinating at least 70% of EU adults by summer

BRUSSELS (Reuters) – European Union states should aim to vaccinate at least 70% of their adult populations against COVID-19 by the summer, the European Commission recommended on Tuesday.

Each of the EU’s 27 governments are managing their own vaccination campaigns, including their pace and which groups get priority. The Commission’s recommendations are not binding.

The 70% goal could mean inoculating over 200 million people, most likely with vaccines which need two doses per person. The EU has so far given a first dose to about 5 million people since it started its rollout at the end of December, the Commission said.

To meet its ambitious goal, the EU executive said it will work to boost the production capacity of vaccine makers with measures that could include investment in plants and faster regulatory procedures to authorize them.

As a mid-term target, by March at least 80% of people over the age of 80, and 80% of healthcare workers should also be vaccinated in each EU state, the Commission said.

The EU has ordered nearly 2.3 billion doses of approved and candidate COVID-19 vaccines, but only the shots developed by Moderna and Pfizer-BioNTech have so far received regulatory clearance in the bloc. They both need two doses to provide full protection.

The EU has secured 600 million doses of the vaccine developed by Pfizer and its German partner BioNTech and, despite early snags in deliveries, expects them to be delivered by the end of this year.

Moderna said it expects to deliver at least 80 million doses to the EU by the third quarter. Decisions on EU approvals of the vaccines developed by AstraZeneca and Johnson & Johnson are expected in coming weeks.

The Commission is also urging EU states to boost their capacity to sequence the coronavirus in order to detect new variants.

It called on EU governments to sequence at least 5% of all positive tests whereas at the moment many states test less than 1% of samples.

“Vaccinations will still take time until they reach all Europeans,” EU health commissioner Stella Kyriakides said, adding that meanwhile testing and sequencing must be increased.

The Commission also said it was working with EU states to adopt a common approach by the end of the month on vaccination certificates to facilitate travel.

(Reporting by Francesco Guarascio @fraguarascio; editing by Philip Blenkinsop, John Stonestreet, Philippa Fletcher, Alexandra Hudson)

New York governor asks Pfizer to directly sell COVID-19 vaccine doses

By Kanishka Singh

(Reuters) – New York Governor Andrew Cuomo asked Pfizer Inc Chief Executive Albert Bourla on Monday if the state could buy COVID-19 vaccine doses directly from the U.S. drugmaker.

Pfizer, however, told Reuters that such a proposal would first require approval by the U.S. Department of Health and Human Services.

“With hospitalizations and deaths increasing across the country this winter, we are in a footrace with the virus, and we will lose unless we dramatically increase the number of doses getting to New Yorkers,” Cuomo said in a letter to Pfizer’s CEO.

Cuomo said he was appealing to Pfizer directly as the company was “not bound by commitments” that Moderna Inc made as part of Operation Warp Speed, the U.S. government’s program to distribute COVID-19 vaccines.

No state has purchased vaccines directly from the producer. Cuomo’s letter did not state how many doses he was seeking or how he would pay for it.

Pfizer said it was open to collaborating with the U.S. Department of Health and Human Services in a way that would ensure quick vaccine distribution to as many Americans as possible.

(Reporting by Kanishka Singh in Bengaluru; Editing by Howard Goller)

Mexico aims to make up for Pfizer vaccine shortfall with others

MEXICO CITY (Reuters) – Mexican President Andres Manuel Lopez Obrador said on Monday the government aimed to compensate for a reduction in deliveries of COVID-19 vaccine doses from Pfizer Inc with those from other providers.

The World Health Organization (WHO) said on Monday it was in advanced talks with Pfizer about including its vaccine in the agency’s portfolio of shots to be shared with poorer countries.

Mexico had been expecting weekly deliveries of some 400,000 doses of the Pfizer vaccine developed with Germany’s BioNTech SE. As a result of the U.S. drugmaker’s WHO agreements, Mexico would for now only be receiving half that total, Lopez Obrador told a regular news conference.

It was not clear how long the reduction would last. Pfizer did not immediately reply to a request for comment.

The Pfizer/BioNTech vaccine is currently the only one being administered in Mexico, which has reported the fourth-highest death toll from the pandemic worldwide.

Mexico has also signed deals to acquire vaccines from Britain’s AstraZeneca Plc and China’s CanSino Biologics. Mexico has approved the AstraZeneca shot and expects to have it by March. It is still reviewing the CanSino vaccine.

Lopez Obrador also noted Mexico was about to complete its review of a Russian vaccine, and would soon have it available, an apparent reference to the Sputnik V product.

Mexico suffered a setback to its drive to inoculate the public with the news over the weekend that the official in charge of the program, Miriam Veras Godoy, had stepped down for personal reasons, according to the health ministry.

(Reporting by Raul Cortes; Editing by Bill Berkrot)

Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout

JERUSALEM (Reuters) – Israel is giving weekly data updates on its COVID-19 outbreak to vaccine maker Pfizer under a collaboration agreement that may help other countries fine-tune their inoculation campaigns and achieve “herd immunity,” officials said.

Israelis began receiving first shots of the vaccine developed by Pfizer and its German partner BioNTech on Dec. 19 in one of the world’s fastest vaccination rollouts.

Israel’s Health Ministry made public most of a 20-page collaboration agreement it signed with Pfizer, which said the aim was “to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel”.

Commercial details such as price and quantity of vaccine shots supplied were not made public, but the agreement said that Israel was relying on Pfizer to deliver enough doses at a fast enough rate to allow it to achieve “herd immunity,” meaning a sufficient portion of the population is immune to the virus.

“While this project is conducted in Israel, the insights gained will be applicable around the world and we anticipate will allow governments to maximize the public health impact of their vaccination campaigns,” BioNTech said on Monday in a statement.

This includes determining potential immunization rates needed to stop the virus from spreading, it said.

The goal, BioNTech said, was “to monitor the evolution of the epidemic over time and at different vaccination rates.”

“This will help us understand whether a potential decrease in cases and deaths can be attributed solely to direct vaccine protection or to both direct and indirect (or ‘herd’) protection,” it said.

During weekly status reports, Israel will provide Pfizer with epidemiological data such as: the number of confirmed COVID-19 cases, hospitalizations, how many patients were on ventilators, how many died, as well as an age and other demographic breakdown.

Such data was available to the public and keeps patients anonymous, Israeli officials said.

About a quarter of Israelis have received their first vaccine shot and 3.5% already got their second dose.

Still, the country is in its third lockdown with infection rates remaining high. More than half a million cases have been reported and 4,005 people have died in Israel since the pandemic began.

(Reporting by Ari Rabinovitch, Ludwig Burger, Nikolaj Skydsgaard and Steven Scheer; Editing by Alex Richardson)

Vaccine nationalism puts world on brink of ‘catastrophic moral failure’: WHO chief

By Emma Farge

GENEVA (Reuters) – The world is on the brink of “catastrophic moral failure” in sharing COVID-19 vaccines, the head of the World Health Organization said on Monday, urging countries and manufacturers to spread doses more fairly around the world.

WHO Director-General Tedros Adhanom Ghebreyesus said the prospects for equitable distribution were at “serious risk” just as its COVAX vaccine-sharing scheme aimed to start distributing inoculations next month.

He noted 44 bilateral deals were signed last year and at least 12 have already been signed this year.

“This could delay COVAX deliveries and create exactly the scenario COVAX was designed to avoid, with hoarding, a chaotic market, an uncoordinated response and continued social and economic disruption,” he said.

Such a “me-first approach” left the world’s poorest and most vulnerable at risk, he said at the opening of the body’s annual Executive Board meeting in virtual format.

“Ultimately these actions will only prolong the pandemic,” he added, urging countries to avoid making the same mistakes made during the H1N1 and HIV pandemics.

The global scramble for shots has intensified as more infectious virus variants circulate.

Tedros said more than 39 million vaccine doses had been administered in 49 higher-income countries whereas just 25 doses had been given in one poor country.

A delegate from Burkina Faso, on behalf of the African group, expressed concern at the meeting that a few countries had “hoovered up” most of the supplies.

Observers say this board meeting, which last until next Tuesday, is one of the most important in the U.N. health agency’s more than 70-year history and could shape its role in global health long after the pandemic ends.

On the agenda is reform of the body as well as its financing system, which was revealed as inadequate after its largest donor, the United States, announced its withdrawal last year.

“WHO has to remain relevant and … has to come out of this crisis with more strength than before,” said WHO Executive Board Vice-Chair Bjoern Kuemmel of Germany in comments last week.

But he expected resistance from some countries to pressure to boost financial contributions.

(Reporting by Emma Farge; Editing by Michael Shields and Nick Macfie)

Fed’s Kashkari sees pandemic hampering activity through all of 2021

(Reuters) – Federal Reserve Bank of Minneapolis President Neel Kashkari on Friday said he believes the pandemic will weigh on Americans through all of 2021, and emphasized the need for a speedier vaccine rollout as well as continued fiscal support.

“It’s a long time until we can get to the other side of that,” he said in a virtual town hall held by the Minnesota Hospital Association, citing new virus variants and the slow rollout of vaccines as making him more cautious over the outlook.

Americans will still need to wear masks and keep social distance through the end of the year, he forecast, delaying the return to normal economic function.

“It’s clear that the pandemic has a way to go and that many many people and many many businesses and hospitals need support until we can get this pandemic behind us, and get back to what we all know is normal, and hopefully strong growth from there,” Kashkari said. “The more that we are able to get the vaccine out faster, the shorter this pandemic will end up being.”

(Reporting by Ann Saphir; Editing by Andrea Ricci)

J&J COVID-19 vaccine could be available in Europe in April: source

By Francesco Guarascio

BRUSSELS (Reuters) – Johnson & Johnson could deliver the first doses of its COVID-19 vaccine to Europe in April, an EU official told Reuters on Wednesday after a top lawmaker said the U.S. healthcare company was likely to seek EU regulatory approval in February.

Clinical data on the vaccine has been assessed by the European Medicines Agency (EMA) since Dec. 1 under a rolling review to speed up possible approval.

A senior EU official, who is involved in negotiations with vaccine makers and spoke on condition of anonymity, said the J&J shot could be available from April 1 in Europe.

Earlier on Wednesday, an EU lawmaker said J&J could seek EU approval for its one-shot vaccine in February.

“EU Health Commissioner Stella Kyriakides announced during our (EU lawmakers) group meeting this morning that the vaccine manufacturer Johnson & Johnson is likely to submit an application for approval to the EU for their vaccine in February,” said Peter Liese, who speaks on health matters for the EU’s center-right group, the assembly’s largest.

Following Liese’s comments, a spokesman for Kyriakides said: “We cannot give any precise indications regarding an application for conditional marketing authorization, but we of course hope that an application could be submitted in the coming weeks.”

EMA, in a statement, said “a date for submission of a marketing authorization application has not yet been confirmed.”

J&J had no immediate comment on the timeline described by the EU source and the lawmaker, which appeared to be slightly behind expectations for the vaccine in the United States.

J&J Chief Scientific Officer Dr. Paul Stoffels told Reuters the drugmaker expects to have clear data on how effective its vaccine is by the end of this month or early February and was on track for a U.S. rollout in March.

The EU drugs regulator had said in December it expected the J&J to apply in the first quarter of this year.

It took EMA 20 days to approve the vaccine developed by BioNTech SE and Pfizer Inc, and just over a month to authorize the Moderna Inc shot after their applications were submitted in early December. The two vaccines are so far the only ones approved in the EU, while AstraZeneca submitted its application on Tuesday.

“If all goes well, we will already have the fourth corona vaccine available in a few weeks,” Liese added.

The EU has booked 200 million doses of the J&J vaccine and has an option to order another 200 million shots. The J&J vaccine is administered as a single shot, while those from Moderna and Pfizer/BioNTech require two doses three or four weeks apart for full protection.

The EU has invested about 360 million euros ($438 million) to secure the J&J vaccine with a down payment that would need to be complemented with payments by EU governments willing to buy the vaccine after approval.

The U.S. government secured 100 million doses from the company for $1 billion in an August agreement, with an option to buy an additional 200 million doses.

(Reporting by Francesco Guarascio; Additional reporting by Julie Steenhuysen in Chicago; Editing by Jason Neely, Louise Heavens and Bill Berkrot)

U.S. releases millions of COVID-19 doses and urges states to include more people

(Reuters) – The Trump administration said on Tuesday it is releasing millions of COVID-19 vaccine doses it had been holding back for second shots and urged states to offer them to all Americans over age 65 or with chronic health conditions.

U.S. Department of Health and Human Services Secretary Alex Azar said during a news briefing that the U.S. pace of inoculations has risen to 700,000 shots per day and is expected to rise to 1 million per day within a week to 10 days.

Most states prioritized health-care workers and nursing home staff and residents for their first deliveries of the COVID-19 vaccines which began last month, following recommendations from the U.S. Centers for Disease Control and Prevention (CDC). The process of inoculating those groups has been slow due partly to the complexity of giving them the vaccines.

CDC head Dr. Robert Redfield said on Tuesday that he “strongly recommends” that vaccines be made available to people over 65 and those younger than 65 who have other chronic health conditions.

The CDC last week made clear that states can move on to the next priority group – people older than 75 and essential workers – without finishing the first round of inoculations, but fewer than 20 states have done so. A handful of states including Texas, Florida and Georgia have started giving shots to people over 65.

(Reporting by Vishwadha Chander and Maria Ponnezhath in Bengaluru and Rebecca Spalding, Carl O’Donnell and Caroline Humer in New York; Editing by Andrew Heavens, Alison Williams and Jonathan Oatis)

Chinese city of Langfang goes into lockdown amid new COVID-19 threat

BEIJING (Reuters) – The Chinese city of Langfang near Beijing went into lockdown on Tuesday as new coronavirus infections raised worries about a second wave in a country that has mostly contained COVID-19.

The number of new cases in mainland China reported on Tuesday remained a small fraction of those seen at the height of the outbreak in early 2020. However, authorities are implementing strict curbs whenever new cases emerge.

The National Health Commission reported 55 new cases on Tuesday, down from 103 on Monday. Hebei province, which surrounds Beijing, accounted for 40 of the 42 locally transmitted infections.

In a village in the south of Beijing that shares a border with Hebei, residents were stopping vehicles and asking to see health-tracking codes on mobile phones.

“We have to be careful as we’re near Guan, where COVID cases were reported today,” said a volunteer security officer surnamed Wang.

At a highway checkpoint, police in protective gowns ordered a car entering Beijing to return to Hebei after the driver was unable to show proof of a negative coronavirus test.

China’s state planning agency said it expected travel during next month’s Lunar New Year period to be markedly down on normal years, with a bigger share of people choosing cars over other transport. Many provinces have urged migrant workers to stay put for the festival.

HOME QUARANTINE

Langfang, southeast of Beijing, said its 4.9 million residents would be put under home quarantine for seven days and tested for the virus.

The government in Beijing said a World Health Organization team investigating the origin of the coronavirus would arrive on Thursday in the city of Wuhan, where the virus emerged in late 2019, after a delay that Beijing has called a “misunderstanding”.

Shijiazhuang, Hebei’s capital, has been hardest hit in the latest surge and has already placed its 11 million people under lockdown. The province has shut sections of highway and is ordering vehicles to turn back.

A new guideline from the Beijing Center for Disease Prevention and Control recommended that taxi and ride-hailing operators suspend car-pooling services, and that drivers should get weekly DNA tests and be vaccinated in order to work, the ruling Communist Party-backed Beijing Daily reported.

As of Jan. 9, China had administered more than 9 million vaccine doses.

Across the country, the number of new asymptomatic cases rose to 81 from 76 the previous day. China does not classify asymptomatic cases as confirmed coronavirus infections.

The total number of confirmed cases reported in mainland China stands at 87,591, with an official death toll of 4,634.

(Reporting by Jing Wang and Andrew Galbraith in Shanghai and Sophie Yu, Roxanne Liu and Lusha Zhang in Beijing; writing by Se Young Lee and Ryan Woo; Editing by Sam Holmes and Kevin Liffey)