It says the Sinopharm vaccine, which has been given to millions of people, is safe and effective.
The World Health Organization (WHO) has given emergency use authorization to a Covid-19 vaccine manufactured by China’s Sinopharm, making it the sixth such inoculation to receive the agency’s green light.
The approval of the jab, which was developed with the Beijing Institute of Biological Products, is for all adults aged 18 and over with a two-dose regimen.The vaccine demonstrated an overall efficacy against Covid-19 of 78.1% in international phase 3 clinical trials and 78.7% efficacy in preventing hospitalization, according to WHO data.“This afternoon, WHO gave emergency use listing to Sinopharm Beijing’s Covid-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality,” the health agency’s Director General Tedros Adhahom Ghebreysus said on Friday.
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He added that the Sinopharm approval expands the list of jabs that can be bought by the COVAX facility – the initiative designed to boost equitable global vaccine distribution.Sinopharm has produced two Covid-19 vaccines in total, with its other jab developed with the Wuhan Institute of Biological Products. This two-dose jab has not yet been approved by the WHO.The other vaccines given the green light by the health agency to date are those from Pfizer-BioNTech, Moderna, Oxford-AstraZeneca, the Serum Institute of India, and Johnson & Johnson.
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While most of the jabs approved by the WHO are either mRNA or viral vector vaccines, Beijing’s Sinopharm product is what’s known as an ‘inactivated’ inoculation.Vaccines in this category contain a dead part of the virus, which when injected will trigger an immune response in the body to fight infection.Sinopharm’s vaccine has also been authorized for adults by some 45 countries and jurisdictions globally, while more than 65 million doses have been administered to date.Think your friends would be interested? Share this story!
The companies are now seeking a “Biologics License Application” for permanent regulatory approval (File)New York: Pfizer and BioNTech said Friday they were launching an application requesting full US regulatory approval for their game-changing Covid-19 vaccine for individuals 16 years and older.The two pharma companies plan to submit data in support of the application “on a rolling basis over the coming weeks” to the Food and Drug Administration (FDA), they said in a press release.The FDA approved the vaccine in December for emergency use, a designation permitted during public health emergencies. Since then, more than 170 million doses of the vaccine have been delivered in the United States.The companies are now seeking a “Biologics License Application” for permanent regulatory approval, which “requires longer-term follow-up data for acceptance and approval,” the companies said.The information will include data on the vaccine efficacy and safety profile up to six months after the second dose in a phase-three clinical trial.”We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the US government,” said Pfizer Chief Executive Albert Bourla.”We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”Pfizer and BioNTech have also submitted data to garner emergency use approval for individuals 12 to 15 years old. Pfizer said earlier in the week that it expects imminent US approval for this application.(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)
The CEO of BioNTech has said the company and its US partner Pfizer will seek approval for a new version of their Covid-19 vaccine that can be stored at normal refrigerator temperatures for up to six months.
At a webcast event organized by the Financial Times on Tuesday, BioNTech’s CEO and co-founder Ugur Sahin said the new version of their much sought-after Covid-19 vaccine could be stored in temperature between two and eight degrees Celsius for a period of up to six months. “Our first formulation had to be stored and shipped at -80 degrees. We now have a formulation, which is not yet approved … that can be stored at two to eight degrees,” Sahin told those watching.
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“We will most likely reach six months’ stability at two to eight degrees,” he stated, adding that data packages were being readied to be sent out to regulators.While the current BioNTech/Pfizer jab has been widely used and is in high demand, the requirement to store the shot at super-cold temperatures means it has little utility in countries or regions without a network of such storage capabilities.At the same video conference, Sahin said BioNTech and Pfizer have been able to further increase production capacity of their Covid-19 vaccine, upping supply to around three billion doses in 2021.If you like this story, share it with a friend!
US drugmaker Pfizer expects to make $26bn (£19bn) in revenues from sales of its Covid-19 vaccine this year, with its soaraway product accounting for more than a third of the company’s annual income.
The vaccine, which was developed with Germany’s BioNTech, contributed $3.5bn in global revenues at Pfizer in the first three months of the year, and the company had expected it to bring in $15bn over the course of 2021.
Now the jab, priced at $39 for two doses in the US and about $30 in the EU, will generate 73% more than forecast. The company said takings from the jab would boost profits.
The new prediction is based on contracts signed until mid-April, for the delivery of 1.6bn doses globally this year. Pfizer is already supplying the US, the UK, the EU, Japan and Israel, among other markets, and is reportedly close to signing a contract with Brazil for 100m doses. It has also struck deals with Canada and Israel to supply the jab beyond this year.
The New York-based company expects to make revenues of between $70.5bn and £72.5bn this year, with the coronavirus jab accounting for $26bn of that sum. Adjusted earnings per share are forecast at $3.55 to $3.65. Previously, it forecast total annual revenues of up to $61.4bn and adjusted earnings per share of $3.10 to $3.20.
Kamala Harris is traveling to Wisconsin today to tout Joe Biden’s infrastructure proposals, marking her first visit to the battleground state since becoming vice-president.
Harris is scheduled to tour clean energy laboratories at the University of Wisconsin-Milwaukee and participate in a roundtable on research and development investments in the American Jobs Plan.
Kamala Harris, who has traveled recently to Maryland, Ohio and Illinois, is off to Wisconsin, her 1st visit there as @VP. She’s going to the University of Wisconsin at Milwaukee for a tour focused on clean energy, the impact of science on communities and federal funding. pic.twitter.com/YU4GtNzpch
May 4, 2021
At least 23 dead as Mexico City metro overpass collapses
A partially collapsed metro overpass has claimed at least 23 lives in Mexico City, where rescuers worked through the night to free trapped passengers and search for victims.
Mexico City’s mayor, Claudia Sheinbaum, said via Twitter that at least 65 people had been taken to hospital after the collapse near the Los Olivos metro station, which occurred at about 10.30pm on Monday.
Videos on Mexican television and social media showed train cars hanging in mid-air as sirens blared nearby. Footage from security cameras showed the overpass collapsing on to a busy thoroughfare as a pair of wagons fell on to passing traffic.
SUUMA Voluntarios 🚑
PRECAUCIÓN: Ambulancias y bomberos en camino por accidente en la estación del metro Olivos, línea 12. 🚑⚠️🚒🚨 pic.twitter.com/UFkcB1llju
May 4, 2021
Another video showed emergency medical crews and firefighters combing through wreckage looking for survivors. Families of people unaccounted for also searched the scene.
“We only heard a thunderous noise and everything started coming apart,” a survivor identifying herself as Mariana told the newspaper El Universal. “We were sent flying and hit the ceiling.”
Sheinbaum said a support beam had given way, causing the overpass to collapse. “Firefighters, public safety personnel are working. Various hospitals attending. We will give more information shortly,” she added.
Harris: ‘Our fates are intertwined’ with Latin America
Kamala Harris delivered virtual remarks to the Washington Conference on the Americas at the White House this morning.
The vice-president emphasized the importance of the relationship between the US and its Latin American neighbors, saying the countries’ “fates are intertwined”.
VP Harris: “The strength of the U.S. depends on the strength of all of the Western hemisphere. In so many ways, our fates are intertwined. That is especially true with Latin America…I want to make clear that our administration firmly believes in the potential of the region” pic.twitter.com/PKqcG8F5ty
May 4, 2021
“The strength of the United States of America depends on the strength of all of the Western Hemisphere,” Harris said. “In so many ways our fates are intertwined. That is especially true with Latin America.”
The vice-president added that the Biden administration “firmly believes in the potential of the region”.
Harris’ remarks come more than a month after Joe Biden put the vice-president in charge of addressing the root causes of migration to the US, which has risen this year.
Although Harris has had the job for a matter of weeks, Republicans have wasted no time in criticizing the vice-president for her handling of immigration, already accusing her of failing to lower the number of migrants attempting to enter the US.
Some House Republicans are already floating names for potential replacements if Liz Cheney is ousted as conference chairwoman.
Congresswoman Elise Stefanik, a New York Republican who became a fierce defender of Donald Trump during his first impeachment inquiry, is among those being named, according to Punchbowl News.
In @PunchbowlNews this morning, we listed some candidates for Cheney’s job. it needs to be a woman, because McCarthy and Scalise are two men.Top tier: @EliseStefanik. This is who most people seem to want. Other names @MaElviraSalazar, @YoungKimCA, @RepAshleyHinson, @NancyMace
May 4, 2021
Liz Cheney, the third most senior membership of the GOP’s House leadership, has been heavily criticized by fellow Republicans in recent months for pushing back on Donald Trump’s nonsense claims that the election was stolen, and for her impeachment vote.
Trump-supporting representatives in Congress have been pushing for Cheney, the House Republican conference chair, to be removed from that powerful position, which could be achieved if House GOP leader Kevin McCarthy called for a vote on Cheney’s future. Shortly after her vote to impeach Trump, the Wyoming GOP had also voted to censure her.
Some Republicans, however, have come to Cheney’s defense. “Liz Cheney is a woman of strength and conscience, and she did what she thought was right, and I salute her for that,” Senator Susan Collins from Maine said on CNN this weekend.
The tension between the most-extreme and less-extreme members of the Republican party has increased in recent days, after Cheney – a member of the latter group – said those who supported the Trump-backed challenges to the certification of the 2020 election should be disqualified from becoming the 2024 Republican nominee.
McCarthy says members worried about Cheney’s ability to ‘carry out the message’
House minority leader Kevin McCarthy appeared open to the idea of ousting Liz Cheney from Republican leadership over her continued criticism of Donald Trump for peddling the “big lie” that there was widespread fraud in the presidential election.
While speaking to Fox News this morning, McCarthy was asked about some House Republicans’ efforts to push Cheney out of her role as Republican conference chairwoman.
“I have heard from members concerned about her ability to carry out the job as conference chair, to carry out the message,” McCarthy said. “We all need to be working as one if we’re able to win the majority.”
“I have heard from members concerned about her ability to carry out the job as conference chair, to carry out the message” — Kevin McCarthy indicates on Fox & Friends that Liz Cheney is likely toast as House Republican Conference Chair pic.twitter.com/afP2D971Zq
May 4, 2021
McCarthy insisted the opposition to Cheney was not related to her vote in support of impeaching Trump after the January 6 insurrection. McCarthy resisted calls to oust Cheney after the impeachment vote, but he now seems to be softening on that.
McCarthy’s comments come amid Cheney’s latest dust-up with the former Republican president. Trump put a statement yesterday morning saying, “The Fraudulent Presidential Election of 2020 will be, from this day forth, known as THE BIG LIE!”
Of course, the “big lie” has come to refer to Trump’s baseless claims of widespread fraud in the election, and Cheney pointed that out in a tweet sent shortly after the statement was released.
“The 2020 presidential election was not stolen,” Cheney said on Twitter. “Anyone who claims it was is spreading THE BIG LIE, turning their back on the rule of law, and poisoning our democratic system.”
The 2020 presidential election was not stolen. Anyone who claims it was is spreading THE BIG LIE, turning their back on the rule of law, and poisoning our democratic system.
May 3, 2021
US pharmacy chains CVS and Walgreens are responsible for the vast majority of wasted vaccine doses, which total more than 180,000 reported to the Centers for Disease Control and Prevention (CDC), according to a story from Kaiser Health News.
As of late March, the CDC recorded 182,874 tossed doses. CVS and Walgreens combined wasted 128,500 doses – CVS wasted about half and Walgreens 21%.
CVS and Walgreens, which have outlets across the US, were tasked by the federal government to help distribute vaccines to residents and staff of long-term care facilities in the weeks after the Pfizer and Moderna vaccines were approved for emergency use by the FDA.
CVS told Kaiser Health News that “nearly all” of its reported wasted vaccines came from that time. Both companies were initially criticized for the slow administration of the vaccines at these facilities.
Biden expected to address FDA’s likely approval of Pfizer shot for 12- to 15-year-olds
Greetings from Washington, live blog readers.
Joe Biden will deliver remarks on the coronavirus pandemic and the US vaccination strategy at the White House later this afternoon.
The president will likely address the news that the Food and Drug Administration is expected to soon authorize administering Pfizer’s coronavirus vaccine to those between the ages of 12 and 15.
The AP has more details:
The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. The person familiar with the process, who spoke on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.
According to Bloomberg’s vaccine tracker, the US has already administered 246,780,203 vaccine doses, and 44.4% of Americans have received at least one shot.
The blog will have more details on Biden’s speech coming up, so stay tuned.
at 2.01pm BST
Ireland’s Covid vaccine rollout has received a double dose of good news, as its National Immunisation Advisory Committee (NIAC) has approved the Johnson & Johnson shot and relaxed the age limits imposed for AstraZeneca’s jab.
The state had limited the AstraZeneca vaccine to those aged 60 and older, after a European Medicines Agency (EMA) review found a possible link between the shot and rare blood clots. Most of the reported clots were in women aged under 60.The NIAC’s new guidance was approved by the Irish government on Tuesday and the age restriction will now be eased, meaning all residents aged over 50 will be allowed to receive the jab. The relaxed rules and addition of the Johnson & Johnson vaccine should see Ireland speed up its rollout across the country.There had been concerns that the Johnson & Johnson vaccine would face severe restrictions after its approval was delayed last week, pending further recommendations from Ireland’s health authority. However, the NIAC signed off on its use in those aged 50 and above, or people aged under 50 if another vaccine was not available or suitable for them.The Johnson & Johnson approval means the one-shot Covid jab can also now be used to vaccinate more vulnerable communities, such as the homeless, who might otherwise have been unable to be inoculated.
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In addition to the AstraZeneca and the J&J jabs, doses of the Pfizer-BioNTech and Moderna vaccines are also being administered in Ireland. The Novavax, CureVac, and Sputnik V jabs are all currently under review and awaiting approval from the EMA and Ireland’s Health Products Regulatory Authority.According to government data, as of 25 April, Ireland had administered almost 1.4 million doses of Covid vaccine, including close to 400,000 second doses. The country has a population of 4.9 million.Like this story? Share it with a friend!