Tag Archives: COVID-19 vaccine

Moderna aims to deliver 1 billion more vaccine doses to low-income countries in 2022

(Reuters) -Moderna Inc said on Friday it aims to deliver one billion doses of its COVID-19 vaccine to low-income countries in 2022, in addition to the doses it has already committed to the global vaccine-sharing platform COVAX.

These vaccines will be part of the 2-3 billion doses the company had forecast to produce next year.

“To date, more than 250 million people have been vaccinated globally with the Moderna COVID-19 vaccine. However, we recognize that access to vaccines continues to be a challenge in many parts of the world,” Chief Executive Officer Stéphane Bancel said in a letter posted on the company’s website.

Moderna on Thursday announced plans to invest up to $500 million to build a factory in Africa to make up to 500 million doses of mRNA vaccines each year, including its COVID-19 shot.

The company had committed in May to supply up to 500 million doses of its COVID-19 vaccine to the COVAX facility from the fourth quarter of 2021 through 2022.

“We are committed to doubling our manufacturing and expanding supply even further until our vaccine is no longer needed in low-income countries,” Bancel said.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Saumyadeb Chakrabarty and Vinay Dwivedi)

Factbox: Countries respond to heart inflammation risk from mRNA shots

(Reuters) – Some countries have halted altogether or are giving only one dose of COVID shots based on so-called mRNA technology to teens following reports of possible rare cardiovascular side effects.

Europe’s drug regulator said in July it had found a possible link between a very rare inflammatory heart condition and COVID-19 vaccines from Pfizer/BioNTech and Moderna.

However, the benefits of mRNA shots in preventing COVID-19 continue to outweigh the risks, European and U.S. regulators and the World Health Organization have said.

Here are some of the steps some countries are taking:

CANADA

The Public Health Agency of Canada said data suggested that reported cases of rare heart inflammation were higher after Moderna’s COVID-19 vaccine compared with the Pfizer/BioNTech shots.

SWEDEN

Sweden paused the use of Moderna’s COVID-19 vaccine for younger groups, citing data from a yet unpublished Nordic study.

The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated.

DENMARK

The Danish Health Agency said on Friday that it was continuing to offer Moderna’s COVID-19 vaccine to under-18s, and that a statement on Wednesday suggesting a suspension had in fact been a miscommunication.

FINLAND

Finland paused the use of Moderna’s vaccines for younger people and instead would give Pfizer’s vaccine to men born in 1991 and later. It offers shots to those aged 12 and over.

HONG KONG

A panel of health experts advising the Hong Kong government has recommended in September children aged 12-17 should get only one dose of BioNTech’s COVID-19 vaccine after reports of heart inflammation as a side effect.

NORWAY

Norway is giving one dose of Pfizer/BioNTech vaccine to children aged 12-15.

UNITED KINGDOM

Britain has been offering all 12-15-year-olds a first a shot of the Pfizer/BioNTech vaccine. Second doses would not be offered to the age group until at least spring when there may be more data from around the world.

(Compiled by Antonis Triantafyllou; Editing by Anna Pruchnicka and Tomasz Janowski)

Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11

WASHINGTON (Reuters) -Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11 year old’s in a 2,268-participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.

The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.

Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”

The United States leads the world in COVID-19 cases and deaths.

Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

A Pfizer spokesperson said the application to the FDA has been completed.

(Reporting by Susan Heavey in Washington and Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Will Dunham, Timothy Heritage and Saumyadeb Chakrabarty)

U.S. FDA advisers may vote on COVID-19 boosters for older adults after rejecting broad approval

By Manojna Maddipatla and Michael Erman

(Reuters) – A panel of expert outside advisers to the U.S. Food and Drug Administration voted against broadly approving COVID-19 vaccine booster shots, but may vote on a narrower approval for older adults later on Friday.

The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration’s plan to roll out third shots of the Pfizer/BioNTech vaccine as soon as next week.

But there was widespread support among panelists for a third dose for older Americans, who are at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots. FDA officials said that a vote to recommend approval for such groups was possible later on Friday.

The FDA will take the panel’s recommendation into consideration in making its decision on the boosters. But it can reject the advice as it did recently in approving Biogen Inc’s controversial Alzheimer’s drug

Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA was incomplete and that the request for approval for people as young 16 is too broad. Most of them said they were not needed yet for younger adults.

Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency’s top scientists arguing they are not needed yet.

If the FDA goes ahead and approves the booster, a separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House said it was ready to roll out boosters next week if health officials approve the plan.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)

BioNTech says vaccine repeats beat devising new one for now

By Ludwig Burger

FRANKFURT (Reuters) -BioNTech said that repeat shots of its COVID-19 vaccine, of which more than a billion doses have now been supplied worldwide, was a better strategy than tailoring the product it developed with Pfizer to new variants.

The German biotech firm said that offering a third dose of its established two-shot vaccine remained the best response to concerns over waning immune protection in the face of the highly contagious Delta variant, as worse strains may emerge.

BioNTech said the more than one billion supply tally as per July 21 was up from 700 million-plus doses it announced in June.

This compares with AstraZeneca saying last month that it and manufacturing partner Serum Institute of India had supplied a billion doses of its vaccine globally.

Based on delivery contracts signed for more than 2.2 billion doses so far, BioNTech said in a statement detailing its second quarter earnings that it expects to accrue 15.9 billion euros ($18.7 billion) in revenue from the vaccine this year, up from a May forecast of 12.4 billion euros.

That includes sales, milestone payments and a share of gross profit in its partners’ territories, BioNTech added.

Pfizer late last month raised its forecast for its share of 2021 vaccine sales to $33.5 billion and said at the time it believes people will need a third dose of the shot.

Pfizer and BioNTech’s decision in early July to seek authorization for a third dose drew criticism from U.S. health regulators, who said there was not yet enough data to show booster shots are needed.

U.S. health agencies have since discussed additional doses for people with compromised immune systems, while Germany and France said they would roll out a third dose for the most vulnerable from September.

That jars with a call by the World Health Organization to use doses instead to jump-start vaccination campaigns in poorer nations which have so far been left behind.

BioNTech Chief Executive Ugur Sahin said that although work was ongoing to adjust the vaccine to variants it was not clear whether yet another version of the pathogen would supplant the now prevalent Delta variant.

“Making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating,” Sahin said during an analyst call.

Chief Medical Officer Oezlem Tuereci said lab experiments had shown that a third shot of the established product generated neutralizing antibodies against a range of strains and that the antibody boost was above the one following a second dose.

Still, the company reiterated plans to start testing a vaccine adjusted to the Delta variant on humans this month, part of a “comprehensive strategy to address variants.”

($1 = 0.8509 euros)

(Reporting by Ludwig BurgerEditing by Chizu Nomiyama and Alexander Smith)

United States buys 200 million more doses of Pfizer/BioNTech COVID-19 vaccine

(Reuters) -Pfizer Inc and German partner BioNTech said on Friday the U.S. government has purchased 200 million additional doses of their COVID-19 vaccine to help with pediatric vaccination as well as possible booster shots – if they are needed.

A Biden administration official with knowledge of the contract said that as part of the agreement, Pfizer will provide the United States with 65 million doses intended for children under 12, including doses available immediately after the vaccine is authorized for that age group.

The U.S. government also has the option to buy an updated version of the vaccine targeting new variants of the virus.

The deal comes as the Delta variant of the coronavirus sweeps across the country and drives up infections, contributing to the debate over whether or not Americans will need a booster dose this fall.

It also follows the government’s move in June to buy 200 million more doses of Moderna Inc’s COVID-19 vaccine.

The purchase brings the total number of doses of the Pfizer/BioNTech vaccine to be supplied to the United States to 500 million, of which roughly 208 million doses have already been delivered, as of Thursday’s data from the government.

“These additional doses will help the U.S. government ensure broad vaccine access into next year,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Pfizer last year signed a deal with the U.S. government for 100 million doses of the vaccine for nearly $2 billion, with an option to buy 500 million more doses.

A majority of the new doses will be supplied by the end of the year, and the remaining 90 million will be delivered by April 30, the companies said.

Pfizer and BioNTech have designed a new version of their vaccine targeting the Delta variant, which they plan to test in the coming weeks, but have said the current vaccine could also provide protection against the variant.

Pfizer earlier this month said the companies plan to seek authorization from U.S. and European regulators for a booster dose of their COVID-19 vaccine.

The U.S. government has said Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.

Advisers to the U.S. Centers for Disease Control and Prevention on Thursday considered evidence suggesting that a booster dose of COVID-19 vaccines could increase protection among people with compromised immune systems.

CDC scientists told advisers that boosters for the immunocompromised would need to wait for regulatory action from the U.S. Food and Drug Administration – either full approval of vaccines or amendments to their current emergency use authorizations – before the CDC could make a recommendation.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Sriraj Kalluvila, Maju Samuel and Dan Grebler)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Sydney’s outbreak throws spotlight on vaccine rollout

Australia’s New South Wales state on Friday reported its biggest daily rise in new COVID-19 cases this year, prompting a tighter lockdown in Sydney and a request for additional vaccine doses that was rebuffed by other state leaders.

Australia reported another record day for vaccination with almost 200,000 doses delivered in one day. Prime Minister Scott Morrison, who on Thursday apologized for the slow pace of inoculation, said the latest data signaled the country’s vaccination rollout had turned a corner.

New Zealand will pause its quarantine-free travel arrangement with Australia for at least eight weeks starting Friday night, Prime Minister Jacinda Ardern said.

Philippines to bar travel from Malaysia, Thailand

The Philippines will suspend travel from Malaysia and Thailand, as well as tighten restrictions in the Manila area, in a bid to prevent the spread of the contagious Delta variant of the coronavirus, the presidential spokesperson said on Friday.

The travel restriction will take effect from Sunday and run to the end of July.

Vietnam’s Ho Chi Minh City extends lockdown

Vietnam will extend a strict lockdown in Ho Chi Minh City until Aug. 1, state media reported on Friday.

After successfully containing the virus for much of the pandemic, Vietnam has been facing a complicated outbreak of the virus, with southern business hub Ho Chi Minh City and surrounding provinces accounting for most new infections.

Banking and securities services in the city will be reduced to minimal levels, while unnecessary construction projects will be suspended.

Taiwan to ease restrictions as cases drop

Taiwan will ease its COVID-19 restrictions next week, the government said on Friday, as rapidly falling case numbers give authorities confidence to further lower the alert level.

Taiwan imposed restrictions on gatherings, including closing entertainment venues and limiting restaurants to take-out service, in mid-May following a spike in domestic cases after months of no or few cases apart from imported ones.

While some of those curbs were eased this month, the so-called level 3 alert has been in force and is due to end on July 26.

Pfizer says U.S. govt buying 200 mln more doses

Pfizer and German partner BioNTech said on Friday the U.S. government had purchased 200 million additional doses of their COVID-19 vaccine and had the option to buy an updated version of the vaccine targeting new variants of the virus.

The announcement brings the total number of the doses to be supplied to the United States to 500 million, out of which roughly 208 million doses have already been delivered.

A longer gap between doses of Pfizer’s vaccine leads to higher overall antibody levels than a shorter gap, a British study found on Friday, but there is a sharp drop in antibody levels after the first dose.

Sinopharm’s shot offers weaker protection among elderly

Sinopharm’s COVID-19 vaccine was less effective in offering protection against the disease among the elderly, according to the results of a Hungarian study.

The study of 450 participants who had received two doses of the vaccine showed measurable antibody levels were present in about 90% of people under the age of 50, but the protection reduced as age increased.

(Compiled by Linda Noakes; Editing by Joe Bavier)

U.S. donation of 1.4 million COVID-19 vaccine doses arrives in Afghanistan

By Doyinsola Oladipo

(Reuters) – A U.S. donation of more than 1.4 million doses of the Johnson & Johnson COVID-19 vaccine arrived in Afghanistan on Friday, the first of two shipments this month, the U.N. children’s agency UNICEF said in a statement.

A second shipment of vaccines donated by the United States through the COVAX global sharing program will bring the total to 3.3 million doses, UNICEF said. The U.S. vaccine donations come as U.S. military forces withdraw from Afghanistan, ending a 20-year war in the country.

The deliveries are part of President Joe Biden’s pledge to share 80 million vaccine doses globally, most through COVAX, which is run by the Gavi Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, the World Health Organization and UNICEF.

“These vaccines arrive at a critical time for Afghanistan as the country faces a difficult surge in COVID-19 infections,” said UNICEF Representative in Afghanistan, Hervé Ludovic De Lys.

Over 1,200 new infections were reported in Afghanistan on July 8th down from a record peak of 1,853 new cases on June 21st, according to the Reuters COVID-19 tracker. Less than four percent of the Afghan population is vaccinated, UNICEF said.

“As many countries face vaccine supply challenges, the dose-sharing mechanism is a rapid way to close the immediate supply gap,” De Lys said. “I hope that other governments will step up and share their doses, supplies and therapeutics to protect those most in need.”

(Reporting by Doyinsola Oladipo, editing by Michelle Nichols and David Gregorio)

COVAX aims to resolve Venezuela COVID-19 vaccine roadblocks after Maduro ‘ultimatum’

CARACAS (Reuters) – The COVAX vaccine-sharing facility is aiming to overcome roadblocks to the shipment of coronavirus shots to Venezuela “as soon as possible,” a spokesman for the GAVI alliance said on Tuesday.

The comments from GAVI, the Vaccine Alliance which runs COVAX with the World Health Organization, came after President Nicolas Maduro on Sunday said he was giving the COVAX system an “ultimatum” to send doses to the crisis-stricken South American country or return the money Venezuela had already paid.

Officials from the OPEC nation said in June that several payments to cover the $120 million fee have been made, but that the final four payments have been blocked by Swiss bank UBS. Maduro’s allies have attributed that to U.S. sanctions aimed at ousting him from the presidency.

“We are working to resolve this matter as quickly as possible,” a GAVI spokesperson said.

Washington in 2019 blacklisted Venezuela’s state oil company, central bank and other government institutions, though it exempts humanitarian transactions from the sanctions.

Still, the measures have left many banks wary of processing even authorized Venezuela-related transactions.

Venezuela’s COVAX payments are not subject to any sanctions, but pose compliance problems for UBS because the government has not satisfactorily spelled out to the bank exactly what the payment is for, a person familiar with the matter said, adding that UBS will execute the transaction as soon as the open questions are clarified.

Venezuela’s information ministry did not immediately respond to a request for comment.

Several of the payments to COVAX were made by local Venezuelan banks on the government’s behalf, Reuters reported last month.

Venezuela has received 3.5 million vaccine doses from allies Russia and China, and is also conducting trials for Cuba’s Abdala vaccine.

(Reporting by Mayela Armas and Michael Shields; Writing by Luc Cohen; Editing by Bill Berkrot)

Moderna’s COVID-19 vaccine shows promise against Delta variant in lab study

(Reuters) -Moderna Inc’s COVID-19 vaccine showed promise against the Delta variant first identified in India in a lab study, with a modest decrease in response compared to the original strain, the drugmaker said on Tuesday.

The study was conducted on blood serum from eight participants obtained one week after they received the second dose of the vaccine, mRNA-1273.

The vaccine provoked an antibody response against all the variants tested, according to Moderna, but one that remained inferior in all cases to the vaccine’s neutralizing activity against the original coronavirus strain first found in China.

The vaccine was far more effective in producing antibodies against the Delta variant than it was against the Beta variant first identified in South Africa, the data showed.

Against three versions of the Beta variant, the vaccine-elicited neutralizing antibodies reduced six-to-eight fold compared to those produced against original strain, while modest 3.2 to 2.1 fold reductions were seen for lineages of the variant first identified in India including Delta and Kappa.

“These new data are encouraging and reinforce our belief that the Moderna COVID-19 vaccine should remain protective against newly detected variants,” Chief Executive Stéphane Bancel said.

Earlier in the day, India granted permission to drugmaker Cipla Ltd to import Moderna’s vaccine to the country for restricted use.

The drugmaker’s shares were up 5.5% at $235.39 in mid-day trading.

Moderna has submitted the data as a preprint to the website bioRxiv ahead of peer review.

(Reporting by Mrinalika Roy in Bengaluru; Editing by Arun Koyyur)