Tag Archives: Vaccine

Sinovac’s coronavirus vaccine candidate approved for emergency use in China- source

BEIJING (Reuters) – Sinovac Biotech Ltd’s coronavirus vaccine candidate CoronaVac was approved in July for emergency use as part of a program in China to vaccinate high-risk groups such as medical staff, a person familiar with the matter said.

China National Biotec Group (CNBG), a unit of state-owned pharmaceutical giant China National Pharmaceutical Group (Sinopharm), also said it had obtained emergency use approval for a coronavirus vaccine candidate in social media platform WeChat on Sunday.

CNBG, which has two vaccine candidates in phase 3 clinical trials, did not say which of its vaccines had been cleared for emergency use.

China has been giving experimental coronavirus vaccines to high-risk groups since July, and a health official told state media in an interview aired last week that authorities could consider modestly expanding the emergency use program to try to prevent possible outbreaks during the autumn and winter.

Officially, China has given little details on which vaccine candidates have been given to high-risk people under the emergency use program and how many people have been vaccinated.

State media reported in June, prior to the emergency use program, that employees at state firms travelling overseas were allowed to take one of the two vaccines being developed by CNBG, while China’s military had also approved the use of CanSino Biologics’ vaccine candidate.

Seven vaccines against the coronavirus are in final trial stages around the world, and four of them are from China.

But no vaccine has yet passed the final stage of trials proving it is safe and effective – conditions usually required to be met to get regulatory approval for mass use. COVID-19 has killed over 800,000 people worldwide.

(Reporting by Roxanne Liu in Beijing and Miyoung Kim in Singapore; Editing by Ana Nicolaci da Costa)

Moderna’s COVID-19 vaccine shows similar immune response in old and young

(Reuters) – Moderna Inc said on Wednesday that an analysis of the early-stage data of its experimental COVID-19 vaccine showed it induced immune responses in older adults that were similar to younger participants.

The drug developer is one of the leading U.S. contenders in the race to develop a safe and effective vaccine against the novel coronavirus and its candidate, mRNA-1273, is already in the Phase 3 stage of human testing.

Moderna is now reporting interim data from the Phase 1 study, which includes new analysis from 20 additional people and details on how the vaccine performs in older people.

The analysis looked at 100 micro gram dosage that has been selected for the larger Phase 3 trial. Moderna said the immune responses in those aged between 56 and 70 years, above 70 and those in the age-group of 18 and 55 were similar.

The data is being presented at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting on Wednesday.

The company has so far enrolled over 13,000 participants in the late-stage study and about 18% of the total participants are Black, Latino, American Indian or Alaska Native, groups that are the hardest hit by the pandemic.

Moderna, which has no drugs in the market, has received nearly $1 billion from the U.S. government under a plan to speed up vaccine development for COVID-19. It has also struck a $1.5 billion supply agreement with the United States.

Shares of the drug developer rose more than 7% to $71.35 after the data. They have more than tripled in value so far this year and results from its studies have boosted the broader market.

(Reporting by Manojna Maddipatla in Bengaluru; Additional reporting by Ankur Banerjee; Editing by Arun Koyyur)

Novavax starts enrollment for phase two of COVID-19 vaccine trial

(Reuters) – Novavax Inc said on Monday it has begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.

In the new phase, the age range has been expanded, with adults between 60 and 84 years accounting for nearly 50% of the trial’s population.

Early-stage data from a small clinical trial of the vaccine has shown it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.

The vaccine candidate is one of nearly 30 being tested in human clinical trials globally and lags candidates from AstraZeneca, Pfizer and Moderna that are in late-stage studies.

The U.S. government in July awarded Novavax $1.6 billion to test and manufacture its vaccine in the United States, with the aim of delivering a 100 million doses by January.

Britain has also tied-up with the company to buy 60 million doses of its vaccine candidate, some of which will be made using Fujifilm Diosynth Biotechnologies facilities in Stockton-on-Tees, northern England.

The study is targeting enrollment of up to 1,500 healthy volunteers at up to 40 sites in the United States and Australia, Novavax said.

Last week, the drug developer began a mid-stage study of its COVID-19 vaccine in South Africa.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Arun Koyyur)

WHO chief hopes coronavirus pandemic will last less than two years

By Stephanie Nebehay

GENEVA (Reuters) – The World Health Organization hopes the coronavirus pandemic will be shorter than the 1918 Spanish flu and last less than two years, WHO chief Tedros Adhanom Ghebreyesus said on Friday, if the world unites and succeeds in finding a vaccine.

The WHO has always been cautious about giving estimates on how quickly the pandemic can be dealt with while there is no proven vaccine.

Tedros said the 1918 Spanish flu “took two years to stop”.

“And in our situation now with more technology, and of course with more connectiveness, the virus has a better chance of spreading, it can move fast because we are more connected now,” he told a briefing in Geneva.

“But at the same time we have also the technology to stop it and the knowledge to stop it. So we have a disadvantage of globalization, closeness, connectedness but an advantage of better technology.

“So we hope to finish this pandemic (in) less than two years.”

He urged “national unity” and “global solidarity”.

“That is really key with utilizing the available tools to the maximum and hoping that we can have additional tools like vaccine.”

More than 22.81 million people have been reported to be infected by the coronavirus globally since it was first identified in China last year and 793,382​ have died, according to a Reuters tally.

(Reporting by Stephanie Nebehay, Michael Shields and Jo Mason; Writing by Nick Macfie; Editing by Hugh Lawson)

What you need to know about the coronavirus right now

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

Pelosi wants COVID-19 deal ‘now’

U.S. House of Representatives Speaker Nancy Pelosi said that Democrats in Congress are willing to cut their coronavirus relief bill in half to get an agreement on new legislation.

“We have to try to come to that agreement now,” Pelosi said in an online interview with Politico. “We’re willing to cut our bill in half to meet the needs right now.”

A senior House Democratic aide said Pelosi was reiterating a standing call by Democrats for the White House and Republicans to meet them “half way” on coronavirus relief.

The Democratic-led House passed legislation with more than $3 trillion in relief in May. Democrats offered this month to reduce that sum by $1 trillion, but the White House rejected it.

Mass testing in UK

Britain plans to bring in regular, population-wide testing for the novel coronavirus so it can suppress its spread and limit restrictions that have crippled one of the worst-hit countries in the world.

Health Secretary Matt Hancock said the government was carrying out trials of a range of new, faster tests that can give instant results and hoped to roll them out towards the end of the year.

Prime Minister Boris Johnson’s government has been heavily criticized for its handling of the pandemic, with critics saying it was too slow to go into lockdown and too slow to roll out testing to know how far the virus had spread.

Church outbreaks spread in South Korea

South Korea reported its highest daily rise in novel coronavirus cases since early March as outbreaks from churches around the capital spread, prompting a warning of a nationwide wave of infections.

The 297 new infections mark the sixth straight day of triple-digit increases in a country that has managed to blunt several previous outbreaks.

At least 166 of the new infections are linked to the Sarang Jeil Church, taking the number of cases from it to 623.

Some members of the church, which is run by a radical conservative preacher, are reluctant to come forward and get tested, or to self-isolate, officials have said.

Part of NZ lockdown illegal

A New Zealand court found the first nine days of a hard lockdown put in place by the government this year requiring people to isolate at home was justified, but unlawful, as an order imposing stay-at-home restrictions was not passed until April 3.

“In the end, the measures taken by the government worked to eliminate COVID-19, save lives and minimize damage to our economy,” Attorney General David Parker said after the ruling.

Prime Minister Jacinda Ardern said on Wednesday she would increase the number of defense personnel at quarantine facilities and borders to beat any spread of the virus, as five new cases in the community were reported.

A warning from the Pope

Rich countries should not hoard a coronavirus vaccine and should only give pandemic-related bailouts to companies committed to protecting the environment, helping the most needy and the “common good”, Pope Francis said on Wednesday.

“It would be sad if the rich are given priority for the COVID-19 vaccine. It would be sad if the vaccine becomes property of this or that nation, if it is not universal and for everyone,” Francis said at his weekly general audience.

The World Health Organization said on Tuesday that any nation that hoards possible vaccines while excluding others would deepen the pandemic.

“The pandemic is a crisis and one never exits from a crisis returning to the way it was before,” Francis said.

(Compiled by Linda Noakes and Karishma Singh; Editing by Robert Birsel)

Brazil approves human trials for potential Johnson & Johnson COVID-19 vaccine

BRASILIA (Reuters) – Brazil’s health regulator Anvisa on Tuesday said it had approved human clinical trials for a potential COVID-19 vaccine developed by Johnson & Johnson’s pharmaceutical subsidiary Janssen.

Brazil is the second-worst hit country for coronavirus cases and deaths after the United States, leading many vaccine developers to seek out clinical trials here.

Brazil had registered 3.4 million cases of the disease and more than 108,000 related deaths as of Monday.

The Johnson & Johnson vaccine candidate is the fourth to be approved for human trials in Brazil, Anvisa said in its statement.

Brazil has already approved phase 3 human trials of potential vaccines developed by AstraZeneca in partnership with the University of Oxford, China’s Sinovac Biotech and Pfizer in partnership with BioNTech.

China’s Sinopharm also aims to carry out trials for a possible vaccine in Brazil in a deal with the southern state of Parana pending regulatory approval.

(Reporting by Ricardo Brito; writing by Jake Spring; editing by Alex Richardson and Jason Neely)

Coronavirus pandemic now driven by younger adults: WHO

By Karen Lema and Neil Jerome Morales

MANILA (Reuters) – The World Health Organization (WHO) said on Tuesday it was concerned that the novel coronavirus spread was being driven by people in their 20’s, 30’s and 40’s, many of whom were unaware they were infected, posing a danger to vulnerable groups.

WHO officials said this month the proportion of younger people among those infected had risen globally, putting at risk vulnerable sectors of the population worldwide, including the elderly and sick people in densely populated areas with weak health services.

“The epidemic is changing,” WHO Western Pacific regional director, Takeshi Kasai, told a virtual briefing. “People in their 20’s, 30’s and 40’s are increasingly driving the spread. Many are unaware they are infected.”

“This increases the risk of spillovers to the more vulnerable,” he added.

A surge in new cases has prompted some countries to re-impose curbs as companies race to find a vaccine for a virus that has battered economies, killed more than 770,000 people and infected nearly 22 million, according to a Reuters tally.

Countries putting their own interests ahead of others in trying to ensure supplies of a possible vaccine are making the pandemic worse, WHO chief Tedros Adhanom Ghebreyesus said in Geneva on Tuesday.

“(Acting) strategically and globally is actually in each country’s national interest – no one is safe until everyone is safe,” he told a virtual briefing calling for an end to “vaccine nationalism”.

Surges in infections have been reported in countries that had appeared to have the virus under control, including Vietnam, which until recently went three months without domestic transmission due to its aggressive mitigation efforts.

“What we are observing is not simply a resurgence. We believe it’s a signal that we have entered a new phase of pandemic in the Asia-Pacific,” Kasai said.

He said countries were better able to reduce disruption to lives and economies by combining early detection and response to manage infections.

While mutations had been observed, the WHO still saw the virus as “relatively stable,” Kasai said.

WHO also reminded drugmakers to follow all necessary research and development steps when creating a vaccine.

Socorro Escalante, its technical officer and medicines policy adviser, said the WHO was coordinating with Russia, which this month became the first country to grant regulatory approval for a COVID-19 vaccine.

“We hope to get the response in terms of the evidence of this new vaccine,” Escalante said.

(Reporting by Ed Davies, Karen Lema, Stephanie Nebehay, Michael Shields and John Miller; Writing by Nick Macfie; Editing by Martin Petty and Ed Osmond)

Novavax begins mid-stage study of COVID-19 vaccine in South Africa

(Reuters) – U.S. drug developer Novavax Inc said on Monday it started a mid-stage study of its experimental COVID-19 vaccine in South Africa, as the country experiences a surge in coronavirus cases.

South Africa is the fifth worst affected country with 583,653 coronavirus cases and 11,677 deaths, according to a Reuters tally.

“Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy,” Novavax research chief Gregory Glenn said.

The trial of Novavax’s NVX-CoV2373, backed by a $15 million grant from Bill & Melinda Gates Foundation, was being conducted in two separate groups, one comprising 2,665 healthy volunteers and the other, 240 HIV-positive adults.

Novavax expects its vaccine, once approved, would be supplied to South Africa through a deal signed earlier this year with the Serum Institute of India to develop and commercialize NVX-CoV2373.

The vaccine candidate is one of nearly 30 globally being tested in human clinical trials.

Early-stage data from a small clinical trial of the vaccine has shown that it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.

Novavax intends to begin Phase 2 of the small clinical trial in the United States and Australia in the near future and said it would include about 1,500 candidates. It also aims to begin Phase III as soon as late September.

The U.S. government in July awarded Novavax $1.6 billion to cover testing its potential coronavirus vaccine in the United States and manufacturing with the aim of delivering a 100 million doses by January.

(Reporting by Sabahatjahan Contractor and Manas Mishra in Bengaluru; Editing by Amy Caren Daniel and Shinjini Ganguli)

WHO downplays danger of coronavirus latching on to food packaging

By Stephanie Nebehay

GENEVA (Reuters) – The World Health Organization on Thursday downplayed the danger of the coronavirus latching on to food packaging and urged people not to be afraid of the virus entering the food chain.

Two cities in China said they had found traces of the coronavirus in imported frozen food and on food packaging, raising fears that contaminated food shipments might cause new outbreaks.

“People should not fear food, or food packaging or processing or delivery of food,” WHO head of emergencies program Mike Ryan told a briefing in Geneva. “There is no evidence that food or the food chain is participating in transmission of this virus. And people should feel comfortable and safe.”

WHO epidemiologist Maria Van Kerkhove said China had tested hundreds of thousands of packages and “found very, very few, less than 10” proving positive for the virus.

More than 20.69 million people have been reported to be infected by the novel coronavirus globally and almost 750,000​ have died, according to a Reuters tally.

The WHO urged countries now that are striking bilateral deals for vaccines not to abandon multilateral efforts, since vaccinating pockets will still leave the world vulnerable.

Russian President Vladimir Putin said on Tuesday that Russia had become the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move Moscow likened to its success in the Cold War-era space race.

Moscow’s decision to grant approval before then has raised concerns among some experts. Only about 10% of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.

The WHO does not have enough information to make a judgment on the expanded use of the Russian vaccine, Bruce Aylward, WHO senior adviser, said at the briefing.

(Reporting by Stephanie Nebehay, Michael Shields and John Miller; Writing by Nick Macfie; Editing by Hugh Lawson)

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)