Tag: Approves

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WHO approves Covid vaccine made by China’s Sinopharm for emergency use

WHO approves Covid vaccine made by China's Sinopharm for emergency use

On April 24, 2021, workers at Damascus International Airport in the Syrian capital unloaded boxes of the Sinopharm Covid-19 vaccine donated by China.

Loua Beshara | AFP | Getty Images

The World Health Organization announced on Friday that it had approved an emergency coronavirus vaccine developed by the Chinese state-owned pharmaceutical company Sinopharm.

Beijing’s Covid vaccine is recommended for adults aged 18 and over with a double dose, WHO Director General Tedros Adhanom Ghebreyesus said at a press conference.

The new addition to the list of usable vaccine options could accelerate efforts to control the spread of Covid-19 and its variant forms, which are causing new infections in many parts of the world.

“To solve the vaccine crisis, we have to pull out all the stops,” said Tedros.

Sinopharm’s shot is the sixth to receive WHO approval for “safety, efficacy and quality,” he said.

“Vaccines remain an important tool. However, at the moment, the volume and distribution of vaccines is insufficient to end the pandemic without the sustained and tailored application of public health measures that we know work,” said Tedros.

“The pandemic has shown that everything is at risk when health is at risk. When health is protected and promoted, individuals, families, communities, economies and nations can thrive,” he said.

The state-owned drug manufacturer’s two-dose Covid shot has already been approved for emergencies in China, the United Arab Emirates and Bahrain.

Another Chinese shot by the private company Sinovac has not yet been approved by the WHO.

In the US, vaccines developed by Pfizer-BioNTech, Moderna, and Johnson & Johnson have received emergency approval from the Food and Drug Administration.

WHO has granted emergency validation for these three shots as well as vaccines made by Astrazeneca-SK BIO and the Serum Institute of India.

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FCC approves SpaceX Starlink modification, regardless of objections

FCC approves SpaceX Starlink modification, despite objections

Cape Canaveral, Florida, USA – A SpaceX Falcon 9 rocket with 58 satellites for SpaceX’s Starlink broadband internet network and three SkySat Earth image satellites will launch from pad 40 at the Cape Canaveral Air Force Station in Cape Canaveral on August 18, 2020, Florida.

Paul Hennessy | NurPhoto | Getty Images

The Federal Communications Commission on Tuesday approved SpaceX’s proposed change to the Starlink satellite license, a win for Elon Musk’s growing broadband network, despite objections from competitors like Amazon, Viasat, and others.

“We conclude that the granting of the SpaceX Third Modification Application is in the public interest,” the FCC wrote in the order. “Our action will allow SpaceX to make safety changes to the deployment of its satellite constellation to deliver broadband services across the United States, including those living in areas underserved or unserved by terrestrial systems.”

SpaceX tabled the amendment a year ago asking for its first 1,584 satellites to be raised to an altitude of 550 kilometers. The FCC approval comes at a crucial time for SpaceX as the company has nearly 1,400 satellites in orbit and likely would have had to suspend its quick start campaign if the FCC hadn’t approved the change.

Starlink is the company’s capital-intensive project to build an interconnected internet network of thousands of satellites, known in the aerospace industry as a Constellation, designed to deliver high-speed internet to consumers around the world.

Opponents submitted numerous responses to the change proposed by SpaceX. Companies like Amazon said doing so would disrupt other satellite networks. SpaceX’s competitors also argued that the change was too significant for the FCC to treat as a simple modification, saying it should instead be included in a wider round of processing with new satellite systems.

The FCC dispute between SpaceX and Amazon became public in January when Musk claimed on Twitter that his competitor was trying to “impede Starlink,” adding that Kuiper was “at best several years away from operations.” While Amazon hasn’t announced when its first Kuiper satellites will launch, the system’s approval by the FCC last year requires the company to deploy half of its planned satellites within six years. This corresponds to the provision of around 1,600 satellites by Amazon in orbit by July 2026.

The regulator denied allegations of signal interference in approving the SpaceX change.

“We also conclude that this change does not cause significant interference issues that would warrant treating the SpaceX system as if it were submitted in a later processing round,” the FCC wrote.

The FCC’s appointment requires SpaceX to issue a report twice a year that includes the number of Starlink conjunctivities – that is, near misses with other satellites – over the past six months and the number of Starlink satellites that have been discarded or re-discarded -enter the earth’s atmosphere.

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New Zealand Approves Paid Depart After Miscarriage

New Zealand Approves Paid Leave After Miscarriage

AUCKLAND, New Zealand – New Zealand’s parliament unanimously passed a law on Wednesday granting three days of paid leave to couples who suffer a miscarriage or stillbirth, making the country the vanguard of those performing such services.

Ginny Andersen, the Labor MP who drafted the bill, said she could not find legislation like it anywhere in the world. “We may be the first country,” she said, “but all of the countries where New Zealand is usually compared to legislation for the 20 week mark.”

Employers in New Zealand, as in some other countries, were already required to grant paid leave in the event of a stillbirth if a fetus is lost after a pregnancy of 20 weeks or more. The new legislation will expand this possibility to anyone who loses a pregnancy at any time, removing any confusion. The measure is expected to take effect in the coming weeks.

“I felt that it would give women the confidence to apply for this vacation when they need to, rather than just being stoic and getting on with life when they knew they needed time, physically or mentally, to read about it to get over grief, ”said Ms. Andersen.

The new law does not apply to those who terminate pregnancies, Ms. Andersen added. New Zealand decriminalized abortion last year, ending the country’s status as one of the few wealthy nations to limit reasons for terminating a pregnancy in the first half.

In Australia, people who have a miscarriage are entitled to unpaid leave if they lose a fetus after 12 weeks, while in the UK prospective parents who have a stillbirth after 24 weeks are entitled to paid leave. The United States does not require employers to take vacation leave for anyone who experiences a miscarriage.

According to the Mayo Clinic, up to 20 percent of all known pregnancies in the United States result in a miscarriage. In New Zealand, which has a population of five million, the Department of Health estimates that one to two pregnancies in ten will result in a miscarriage.

Sands New Zealand charity, which supports parents who have lost pregnancies, says 5,900 to 11,800 miscarriages or stillbirths occur each year. According to the New Zealand College of Midwives, more than 95 percent of miscarriages occur in the first 12 to 14 weeks of pregnancy.

A miscarriage or stillbirth remains a difficult and painful topic that health lawyers say is difficult to talk about in public or seek support.

“If you call the hospital and say,” I think I miscarried my baby, “so many women will say,” I felt like the first person in the world to miscarry, “said Vicki Culling. an educator on baby loss who advocated better support for the bereaved in New Zealand.

“The very foundations of your world are crumbling just because you expect to have this beautiful baby, and when that baby dies, whether in the womb or shortly after birth, everything is broken.”

Ms. Culling welcomed New Zealand legislation as a first step, but said more needed to be done.

“You get three days of paid vacation, maybe you bury your baby or you have a job, and then you go back to work and carry on – and then what? That’s my concern, ”she said.

“I celebrate, but I want us to maintain that compassion and delve deeper into the needs of these parents.”

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FDA approves J&J’s single-shot Covid vaccine for emergency use

FDA approves J&J's single-shot Covid vaccine for emergency use

The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use. This gives the US a third tool to fight the pandemic as highly contagious variants are gaining a foothold across the country.

With the FDA’s approval for the emergency on Saturday, the federal government’s plan begins to distribute nearly 4 million doses of J & J’s vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizer and Moderna vaccines, patients with the single dose of J&J do not need to take a second dose and can be stored at refrigerator temperature for months.

J & J’s vaccine “makes it easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

Initially, doses would be limited, J&J said. The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. US officials say they are working with the company to increase supply as soon as possible.

In the past few weeks, US health officials have urged Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, particularly strain B.1.351, which has been shown to decrease the effectiveness of vaccines both in market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, the declines in Covid-19 cases reported in the US since early January could flatten as the variants spread.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. However, FDA documents show that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The Pfizer vaccine was found to be 95% effective against Covid-19, while the Moderna vaccine was around 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved J & J’s vaccine for people 18 years of age and older. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no indication of benefit” in coronavirus patients.

The FDA was expected to approve J & J’s emergency vaccine.

The agency’s announcement comes after a key panel unanimously endorsed the emergency vaccine on Friday. The FDA’s Advisory Panel on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

No specific safety concerns were identified with J & J’s vaccine. Headache, fatigue, and muscle aches were some of the most common side effects among people who received the vaccination, according to an FDA report released Wednesday. There have also been reports of nausea, fever and injection site pain, the report said.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The company has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that are between minus 112 and minus 76 degrees Fahrenheit. However, the FDA recently allowed the company to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

This is a developing story. Please try again.

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U.Ok. Approves Examine That Will Intentionally Infect Volunteers With Coronavirus

U.K. Approves Study That Will Deliberately Infect Volunteers With Coronavirus

LONDON – In the coming weeks a small, carefully selected group of volunteers is expected to arrive on the 11th floor of a London hospital to learn what the rest of the 7.8 billion people around the world have tried to avoid: coronavirus infection .

Tiny droplets of the virus are given into their noses as part of a plan approved by UK regulators on Wednesday to intentionally infect unvaccinated volunteers with the coronavirus.

The scientists hope to eventually expose vaccinated people to the virus to compare the effectiveness of different vaccines. Before doing so, however, the project’s supporters must expose unvaccinated volunteers to determine the lowest dose of the virus that will reliably infect them.

Up to 90 people could take part in the study, but the number could be fewer if researchers can determine the correct dose with fewer volunteers.

By controlling the amount of virus people are exposed to and monitoring it from the time they are infected, scientists hope to discover things about how the immune system reacts to the coronavirus that would be impossible outside of a laboratory – and devise ways to do it directly to infect comparing the effectiveness of treatments and vaccines.

“We will learn a lot about the immunology of the virus,” said Peter Openshaw, a professor at Imperial College London who was involved in the study, on Wednesday. He added that the study would be able to “not only accelerate understanding of diseases caused by infections, but also accelerate the discovery of new therapies and vaccines”.

The idea of ​​such a study, dubbed the Human Challenge Challenge, has been hotly debated since the early months of the pandemic.

In the past, scientists have deliberately exposed volunteers to diseases such as typhoid and cholera to test vaccines. But infected people could be cured of these diseases. Covid-19 has no known cure, which puts the scientists responsible for the UK study into largely unknown ethical territory.

To ensure participants do not get seriously ill, the UK study will be limited to young, healthy volunteers aged 18 to 30 years.

But these types of patients also had severe Covid 19 cases, and the long-term consequences of an infection are also largely unknown. Age restrictions can also make it difficult to extrapolate the results to older adults or people with pre-existing medical conditions, whose immune responses may differ, and who are the target audience for treatments and vaccines.

“It will be a limited study,” said Ian Jones, professor of virology at the University of Reading, who is not part of the study. “And you could argue that, by definition, it won’t investigate those where it is most important to know what is going on.”

Currently the only part of the study that has been officially approved by UK regulators is the experiment to determine the lowest dose of virus needed to infect humans.

After exposure to the virus, participants will be isolated in hospital for two weeks. They will be paid £ 4,500, or about $ 6,200, for this one year worth of scheduled follow-up appointments. The researchers said this would compensate people for their absence from work or family without creating too much economic incentive for people to participate.

When the idea of ​​human challenge experimentation first came out last year, some scientists saw it as a way to cut the crucial time in the race to identify a vaccine. Unlike large clinical trials where scientists wait for vaccinated people to encounter the virus in their communities, researchers in this project might infect people who were vaccinated on purpose.

With multiple vaccines approved, the goals of this human challenge study are slightly different.

For now, researchers will be exposing people to the version of the virus that has been spreading across the UK since last spring, rather than the contagious and potentially more deadly variant that has caught on more recently. But eventually, they said, they could give people experimental vaccines to combat the effects of new, more worrisome variants, and then expose them to those versions of the virus.

You could also directly compare different vaccine doses and dosing intervals for the same vaccine.

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Maryland Approves Nation’s First Tax on Large Tech’s Advert Income

Maryland Approves Country’s First Tax on Big Tech’s Ad Revenue

State politicians struggling with yawning budget gaps due to the pandemic have made no secret of their interest in preserving a greater chunk of the tech industry’s wealth.

Now Maryland lawmakers are taking a new step: the country’s first tax on digital ad revenue sold by companies like Facebook, Google, and Amazon.

The Senate voted Friday to overturn the governor’s veto on the measure, following in the footsteps of the state’s House of Representatives, which gave its approval on Thursday. The tax will generate up to $ 250 million in the first year after it goes into effect, with the money going to schools.

The approval signals the arrival of policies developed by European countries in the United States, and it is likely to spark a heated legal battle over how far communities can go to tax the tech companies.

Other states are making similar efforts. For example, lawmakers in Connecticut and Indiana have already introduced bills to tax the social media giants. Several other states, like West Virginia and New York, didn’t enact new taxes on the tech giants in the past year, but their proponents could renew their foray into Maryland’s success.

The moves are part of an escalating debate about the economic power of tech giants as companies have grown, become gatekeepers to communication and culture, and started collecting tons of data from their users. In the United States, law enforcement agencies launched multiple antitrust proceedings against Google and Facebook over the past year. Members of Congress have proposed laws to review their market power, encourage them to moderate the language more carefully, and protect the privacy of their users.

Maryland’s tax also reflects the collision of two economic trends during the pandemic: The biggest tech companies hit milestones in their financial performance as social distancing continued to move work, play and commerce online. However, in cities and states, tax revenues declined as the need for social services increased.

“You’re really getting bruised,” said Ruth Mason, a professor in the University of Virginia law school. “And this is a great way to put a tax on pandemic winners.”

Lobbying groups for Silicon Valley companies like Google and Facebook have joined other opponents of the law – including Maryland Republicans, telecommunications companies, and local media – arguing that tax costs are passed on to small businesses that buy ads and their customers. Doug Mayer, a former adjutant to Governor Larry Hogan, who now leads a coalition supported by industry opponents of the tax, said at a news conference last week that advocates for the law “are using this bill to crack down on the state, faceless large corporations. “

“But they swing and miss and hit their own ingredients in their mouths,” he said.

Maryland tax, which applies to digital ad revenue from within the state, is based on the ad sales a business generates. A company that has worldwide sales of at least $ 100 million per year but no more than $ 1 billion per year should expect a 2.5 percent tax on its ads. Companies that make more than $ 15 billion a year pay a 10 percent tax. The worldwide turnover of Facebook and Google is well over 15 billion US dollars.

Bill Ferguson, a Baltimore Democrat who is President of the Senate, was a major driving force behind the bill. He said he was inspired by an op-ed paper by economist Paul Romer, in which he suggested taxing targeted ads to encourage companies to change their business models.

“This idea that an outsider can use and use someone else’s personal information and pay nothing to use it doesn’t work in the long run,” Ferguson said.

Maryland’s democratically controlled legislature passed the tax last March with a veto-proof majority. But Mr Hogan, a moderate Republican, vetoed the measure in May.

“Since our state is in the midst of a global pandemic and an economic collapse and is only just on the way to recovery, it would be incomprehensible to raise taxes and fees now,” Hogan explained his argument in a letter.

End of last year, industry groups helped set up a lobbying organization to prevent lawmakers from overriding Mr. Hogan’s veto.

For months, the Marylanders for Tax Fairness organization, backed by some of Silicon Valley’s leading lobby groups, has been warning Maryland lawmakers on cable news and local radio that a proposed digital advertising tax is a “bad idea” in a ” bad “be time.”

The coalition has highlighted the stories of small businesses that it says will ultimately pay the cost of the new tax when they buy ads online.

“A new $ 250 million tax during a pandemic,” the powerful narrator told an ad on a video of a bar in Annapolis. “Tell your lawmakers: Stop the digital advertising tax.”

While some states impose sales tax on some digital goods and services when they are purchased by customers, the Maryland tax is the first to be applied solely to revenue generated by a digital advertising company in the United States, experts say . The state lawmaker is expected to pass a second bill in the coming days clarifying that the tax does not apply to media companies and that the costs cannot be passed directly on to companies that buy ads, despite critics saying that the tax will still lead to higher tax rates on ads.

European politicians have turned to digital taxes in recent years as part of a major regulatory push against American tech giants. France has imposed a 3 percent tax on some digital revenues. Austria taxed income from digital advertising at 5 percent. The European efforts have been condemned by the Trump administration, which threatened to impose tariffs on French goods on the matter.

“I don’t think the issue is any different in Maryland than it is in California, India, France or Spain,” said Senator James Rosapepe, a Democrat who is the vice chair of the tax committee. “Since they are so profitable, they should pay taxes.”

Maryland’s tax is likely to be brought to justice.

Opponents can argue that the law taxes out-of-state activities that are against the Constitution because the largest tech companies are not based in Maryland. You can also argue that the law violates a federal law that says taxes on digital goods or services must also apply to equivalent physical products.

“It’s tax discrimination,” said Dave Grimaldi, executive vice president of public policy at IAB, an online advertising trading group. “Once it goes into effect, there will be all kinds of challenges.”

But supporters of the law said they believed they were on solid ground to tax the giants.

“We believe that even if the overwriting is done, the industry is likely to file a lawsuit,” Ferguson said. He said lawmakers asked the attorney general if they could defend the law.

“And they have,” he said. “You have signed out.”

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FDA approves new gadget worn in the course of the day to cut back loud night breathing and sleep apnea

FDA approves new device worn during the day to reduce snoring and sleep apnea

The U.S. Food and Drug Administration on Friday approved a new device that can help prevent sleep apnea and snoring – and that doesn’t have to be worn at night.

People who snore – and their partners – have very few options in the market right now to alleviate their suffering. And a lot of what is available involves uncomfortable mouthguards or noisy C-Pap machines.

Approved on Friday, the eXciteOSA device is the first of its kind to be approved to treat sleep apnea and snoring by improving tongue muscle function by electrically stimulating the tongue through a mouthpiece worn for 20 minutes a day. It helps retrain the tongue to prevent it from collapsing backwards and blocking airflow while you sleep.

Obstructive sleep apnea is widespread and occurs when the upper airway becomes repeatedly blocked during sleep, reducing or completely blocking airflow. If left untreated, OSA can lead to serious complications such as glaucoma, heart attack, diabetes, cancer, and cognitive and behavioral disorders.

“Obstructive sleep apnea not only affects the quality of sleep, it can also have other serious health effects if left untreated. Today’s approval provides a new option for thousands of people with snoring or mild sleep apnea,” said Dr. Malvina Eydelman, director of the Ophthalmic, Anesthetic, Respiratory, ENT, and Dental Devices Bureau at the FDA’s Center for Equipment and Radiological Health.

The eXciteOSA mouthpiece has four electrodes, two above the tongue and two under the tongue. It provides electrical muscle stimulation in sessions that consist of a series of electrical impulses with periods of rest in between. It is used once a day for 20 minutes while you are awake, for 6 weeks, and then once a week thereafter.

The agency said the device reduced loud snoring by 20% in 87 of the 115 patients studied. Of the patients who all snored, 48 also had mild sleep apnea.

The most common side effects observed were excessive salivation, tongue or tooth discomfort, tongue tingling, tenderness to filling, metallic taste, gagging, and tight jaw.

The FDA has granted Signifier Medical Technologies marketing authorization.

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UK regulator approves Moderna Covid vaccine

AstraZeneca to work on vaccine with Russia's Gamaleya

CSL staff will be working in the laboratory on November 08, 2020 in Melbourne, Australia, where they will begin manufacturing the AstraZeneca-Oxford University’s COVID-19 vaccine.

Darrian Traynor | Getty Images

The UK regulator has approved Moderna’s coronavirus vaccine for use in the country, the Ministry of Health said on Friday.

It is the third Covid shot approved for use in the UK following previous vaccine approvals from Pfizer and BioNTech, as well as Oxford and AstraZeneca universities.

In a press release, the department announced that the Moderna vaccine met the “stringent standards for safety, efficacy and quality” set by the drug and health product regulator.

It added that the UK had ordered an additional 10 million doses of the vaccine, bringing the total to 17 million. They are expected to be available from spring.

This is a developing story and will be updated shortly.

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India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Different

India Approves Oxford-AstraZeneca Covid-19 Vaccine and 1 Other

NEW DELHI – India announced on Sunday that it has approved two coronavirus vaccines, one made by AstraZeneca and Oxford University and the other developed in India for emergency use. This is an important step in stopping the coronavirus from spreading in one of the toughest in the world. countries hit.

The permits were announced at a press conference in New Delhi on Sunday. Dr. VG Somani, the Indian drug control officer, said the decision to approve the Oxford-AstraZeneca vaccine and a local vaccine developed by Bharat Biotech was made after “careful review” of both by the Central Drugs Standard Control Organization, India’s Indian medicines agency .

Indian regulators are still considering approvals for other vaccines. One made by Pfizer and BioNTech has already been approved in the US and Europe. Another, Russia’s Sputnik V, seems less far away.

The UK became the first country to issue emergency approval for the Oxford-AstraZeneca vaccine on Wednesday. Argentina soon followed.

Officials in India moved quickly for several reasons. The country ranks number 2 in confirmed infections behind the United States, and the outbreak is widely believed to be worse than official numbers suggest. The pandemic has devastated the economy and the unemployment rate is at a 45-year high. Education has been disrupted, leading to concerns about the long-term impact on the country’s youth.

India is now facing major challenges. Cans for more than 1.3 billion people have to be paid for and distributed over a vast country. Government officials may also have public doubts about the vaccine’s safety and effectiveness, partly due to the government’s lack of transparency about clinical trial protocols.

Criticism of the ambiguity of the data examined by the regulator came quickly after the two emergency vaccines were approved.

All India Drug Action Network, a public health watchdog, immediately issued a statement requesting more information on the scope of clinical trials and dosage regimens for both vaccines.

Regarding the Bharat biotech vaccine called Covaxin, the group said it was “baffled to understand the scientific logic that motivated the top experts” to approve a vaccine that is still in clinical trials.

Dr. Somani, the regulator, said the vaccine had been given to 22,500 study participants and “found safe” to date.

Both the AstraZeneca vaccine and the Bharat Biotech vaccine require two doses, said Dr. Somani. He did not state whether participants in Bharat Biotech’s ongoing clinical trials received both doses.

The effort has already been fraught with setbacks. The Serum Institute, an Indian drug company that had an agreement to make the Oxford vaccine before it was proven to be effective, has managed to produce only about a tenth of the 400 million doses it promised to make before the end of the year.

The government says it’s ready. To get the vaccine to a country known for its size and sometimes unreliable roads, officials will leverage knowledge from nationwide campaigns against polio and newborn vaccinations, as well as the skills and flexibility used in India’s mammoth general election where ballot boxes are delivered to the US furthest from the country.

The Serum Institute says it is on the right track to ramp up production of the vaccine known in India as Covishield. With $ 270 million of its own funds and $ 300 million from the Bill and Melinda Gates Foundation, Serum plans to increase production capacity to 100 million doses per month by February, said Mayank Sen, a company spokesman.

First, the Serum Institute signed a pact with AstraZeneca to manufacture one billion doses of the vaccine for low and middle income countries. The vaccine is attractive to developing countries because it is cheaper to manufacture and easier to transport than those which require colder temperatures during storage and transportation.

The Serum Institute experienced production delays when it built new facilities to manufacture the vaccine. It is said to have produced between 40 and 50 million cans for the world. The company’s chief executive Adar Poonawalla told reporters on Monday that the majority of the cans will be given to India.

Indian officials were unsure of how many doses to receive and when. Mr Sen said the Serum Institute had no firm agreement with the Government of India, but had committed to reserve most of its existing inventory for India.

“The government has not yet signed the papers and the final dotted line, but this is based on initial discussions we had because we have always said India will be the priority,” said Sen.

Until the vaccine is approved by the World Health Organization, serum will begin shipping doses at manufacturing cost to other developing countries, Sen said.

India’s approval process has also been delayed. The Serum Institute filed for emergency approval earlier last month, but regulators requested additional details from clinical trials, including whether any person involved in the trials had had any medical complications.

The details of this claim are not clear. After receiving the Covishield vaccine on October 1, a 40-year-old volunteer from Chennai, India, publicly reported neurological symptoms to the Serum Institute in a legal notice. The company threatened defamation lawsuits and required volunteers to pay approximately $ 13.7 million. While negative health effects from vaccine trials are rare, health professionals risked the Serum Institute promoting misinformation by punishing someone for speaking up.

Mr Poonawalla said Monday that the Serum Institute had submitted the additional information that regulators had requested. It has denied that the problems reported by the Chennai trial participant had anything to do with Covishield but refused to comment on allegations of intimidation.

Indian officials have drawn up an ambitious plan to vaccinate the country’s huge population. This is the greatest effort of this kind in the country’s history.

India plans to launch a vaccination campaign in the first three months of the year that will cover about a quarter of the population by August. The first 30 million people vaccinated will be health care providers, then police and other frontline workers. For the remaining 270 million people, authorities will focus on those over 50 who are suffering from conditions that may make them more vulnerable.

The rest of the population will be immunized based on the availability of vaccines and the latest scientific knowledge.

India has a long history of vaccinating its people. India’s first mass vaccination took place in 1802 to combat smallpox. Subsequent efforts suffered from misinformation and slow adoption.

The country has made progress in recent years. In the fight against polio, government officials ran informational campaigns to religious leaders to almost eradicate the disease. According to a study, a mass measles vaccination campaign between 2010 and 2013 saved the lives of tens of thousands of children.

For the coronavirus campaign, the national government has asked the states to prepare vaccination strategies. Some have established task forces at the state, district and block levels. To date, more than 20,000 health workers in around 260 districts have been trained to administer the vaccine, according to the Indian Ministry of Health.

The government plans to use the framework of its universal vaccination program for pregnant women and newborns – one of the largest and cheapest public health interventions in the world.

Indian civil aviation minister Hardeep Singh Puri said Tuesday that airlines, airports and ground handlers have been asked to develop plans to transport vaccine bottles in cold temperatures.

This week, health workers in four Indian states conducted an exercise to iron out wrinkles. Health officials in various locations distributed over 100 doses of placebo vaccine to trainers. They then tracked the temperature of the cans on the way from the train depot to the vaccination site, as well as the time and whether they reached the intended patient.

India has yet to improve its ability to store and transport vaccines under temperature controlled conditions known as the cold chain network, as well as improve distribution methods and train new workers.

India may need to double its health care workforce from its current 2.5 million, said Thekkekara Jacob John, a senior virologist in southern Tamil Nadu state.

“This is a Herculean task,” said John of the vaccination effort. “And the challenge is not in densely populated cities, but in rural areas – home of real India.”

Government officials must also stop the rumor, he said. Chat groups on WhatsApp, Facebook’s widespread messaging service in India, have already become misinformation about side effects.

A month ago, Prime Minister Narendra Modi urged citizens to look out for those trying to spread rumors about the vaccine, which he called “anti-national and anti-human” and urged politicians to help raise awareness .

Mr Modi renewed that appeal on Thursday, throwing the continued fight against the virus as one against an unknown enemy.

“Be careful of rumors,” he said, “and as a responsible citizen, you must not post messages on social media without checking.”

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China Approves Sinopharm’s Covid-19 Vaccine because it Strikes to Inoculate Tens of millions

China Approves Sinopharm's Covid-19 Vaccine as it Moves to Inoculate Millions

The Chinese government said on Thursday that it had approved a homegrown coronavirus vaccine after an early analysis of clinical trial results showed that it was effective. The announcements sent a positive signal for the global rollout of Chinese vaccines but lacked crucial details.

The manufacturer, a state-controlled firm called Sinopharm, said on Wednesday that a vaccine candidate made by its Beijing Institute of Biological Products arm had an efficacy rate of 79 percent based on an interim analysis of Phase 3 trials. Sinopharm said it had filed an application with Chinese regulators to allow the vaccine to be used broadly, and on Thursday the government said the vaccine had been granted conditional approval.

If supported, the interim results will bolster claims that Chinese officials have made in recent days that the country’s vaccines are safe and effective. Even before the government issued its official approval, the authorities had already moved ahead with mass vaccinations, defying industry norms. They plan to vaccinate 50 million people in China by mid-February, when hundreds of millions are expected to travel for the Lunar New Year holiday.

But Sinopharm’s announcement provided no breakdown of results and left many questions unanswered, adding to a lack of clarity that has dogged China’s coronavirus vaccine development for months. Wu Yonglin, Sinopharm’s president, said on Thursday that the company would publish details of the trials in major academic journals later.

China’s drive to develop a homegrown vaccine speaks to the country’s technological and diplomatic ambitions. A successful vaccine would support the country’s claim as a peer and rival to the United States and other developed countries in biomedical sciences.

The Sinopharm vaccine’s results show that it is less effective than others that have been approved in other countries. Still, the results are well above the 50 percent threshold that makes a vaccine effective in the eyes of the medical establishment.

Two other coronavirus vaccines, made by Moderna and Pfizer-BioNTech, have been shown to have an efficacy rate of about 95 percent. The Pfizer-BioNTech vaccine has received authorization in more than 40 countries. Moderna’s vaccine has been authorized in the United States, and other countries are evaluating its trial results. Russia has announced that its Sputnik V vaccine has an efficacy rate of 91 percent and has begun a mass vaccination campaign.

Beijing has leaned heavily on the promise of its vaccines to strengthen ties with developing countries deemed vital to China’s interests. Officials have toured the world pledging to provide Chinese vaccines as a “global public good,” a charm offensive that the United States may seek to counter, particularly when the campaign encroaches on its backyard.

The political stakes in the race for a vaccine are particularly high for China’s authoritarian Communist Party, which has been criticized for stifling information and playing down the virus when it first emerged in the city of Wuhan late last year.

A successful vaccine, if quickly made available to the world, could help repair the party’s image globally and that of its leader, Xi Jinping. The Chinese companies have said their vaccine would be cheaper and easier to transport, which if proven could give them significant appeal in the developing world.

Chinese vaccines may still be greeted with other questions. Scientists said that the headline figures released by Sinopharm were encouraging but that the lack of supporting data made it difficult for the results to be independently assessed.

Covid-19 Vaccines ›

Answers to Your Vaccine Questions

With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:

    • If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
    • When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
    • If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
    • Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
    • Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

Sinopharm on Wednesday did not disclose the size of the trial population or provide detailed information about any serious side effects, data points that scientists look for in such releases. On Thursday, Mr. Wu, Sinopharm’s president, said at a news briefing that more than 60,000 people had been vaccinated as part of the trials.

“With each of these vaccines we’re dealing with bits and pieces of information, but the Chinese companies have provided even less information than the Russian companies have,” said Dr. Kim Mulholland, a pediatrician at the Murdoch Children’s Research Institute in Melbourne, Australia.

“At least with the Russian vaccines we were told the number of cases and the basis of evidence for why their vaccine was effective,” said Dr. Mulholland, who has been involved in the oversight of many vaccine trials, including ones for a Covid-19 vaccine.

Michael Baker, a professor with the department of global health at the University of Otago in Wellington who is an adviser to the New Zealand government, said that while the initial figures from Sinopharm looked promising, without more information it was difficult to know for sure.

“It’s pretty light on the details,” he said. “One question is: What markets do they propose to use these vaccines in? Because if they want to have a global market, they’re obviously going to have to supply all those details.”

Details about the efficacy of another Chinese vaccine candidate, made by Sinovac, a private Beijing-based vaccine maker, have also been released in a piecemeal fashion.

The absence of detailed information on the safety and efficacy of Chinese vaccines has not stopped officials in the country from administering them to the public. Officials in several provinces and cities say they are focusing on what China calls “key priority groups” — doctors, hotel employees, border inspection personnel and workers in food storage and transportation, as well as travelers — in an ongoing inoculation drive.

Chinese officials and companies had already administered Chinese-made vaccines, mostly made by Sinopharm, to more than a million people in China. The campaign drew criticism from overseas scientists who said they were concerned that the authorities did not closely monitor people after they received injections outside clinical trials.

To China, a vaccine that can help protect its 1.4 billion people is crucial to its plans to revitalize the economy.

The country has largely stamped out the coronavirus with a combination of restrictions on foreign arrivals, mass testing and tight lockdowns of neighborhoods whenever any cases are detected. But officials remain concerned that the winter could bring a new wave of infections and hope that a widely available vaccine can help prepare the country for when regular travel and trade resume.

Already, new local outbreaks were being reported in Beijing and the northern city of Shenyang this week, prompting the imposition of new measures. In Shenyang, officials declared that the city was in “wartime status” as they rolled out restrictions on large-scale gatherings including group meals, training sessions and end-of-year parties.

Sinovac and Sinopharm use inactivated coronaviruses to make their vaccines — a tried-and-true method dating back over 130 years. The companies use chemicals to disable the virus’s genes so that it cannot replicate. Yet the inactivated coronavirus can still cause the body’s immune system to produce antibodies against it. By comparison, Moderna and Pfizer are taking a revolutionary gene-based approach that had never before been approved for widespread use.

Experts say there are drawbacks to inactivated vaccines like the ones being made by Sinovac and Sinopharm. They require starting off with large batches of live coronavirus samples, which can pose a biosecurity risk. Once the live samples are inactivated, it takes an extra manufacturing step to ensure that none of them survive the treatment.

Another advantage of the vaccines produced by Moderna and Pfizer is that they are faster to make and said to be more stable than traditional vaccines. Pfizer projects that it will be able to produce up to 1.3 billion doses in 2021, while Moderna expects to be able to make 500 million to one billion doses.

The Chinese government has promised to produce 610 million doses by the end of the year and expects to make more than one billion doses next year. Several large countries like Brazil and Indonesia, where Chinese companies have been conducting trials, have each received shipments of more than a million doses of Sinovac vaccines. Turkey has ordered 50 million doses.

People who were previously vaccinated in China have said the two-dose regimen costs about $60 to $150. According to people who have received the Sinovac vaccine, the company is charging about $30 a dose. Sinopharm has said the cost of two doses should be lower than $150. Zeng Yixin, the deputy minister of the National Health Commission, said on Thursday that the vaccine would be provided to the Chinese public for free, a reversal of previous statements by Chinese officials.

Reporting and research were contributed byElsie Chen, Claire Fuand Amber Wang.