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Biden Shifts Vaccination Technique in Drive to Reopen by July 4

Biden Shifts Vaccination Strategy in Drive to Reopen by July 4

WASHINGTON – President Biden, faced with delayed vaccinations threatening his promise of near-normalcy through July 4th, revised its strategy to fight the pandemic on Tuesday, moving from mass vaccination sites to more local facilities to appeal to younger Americans and those who hesitate to get a shot.

In a speech at the White House, Mr Biden said he was launching a new phase in the fight against the coronavirus, with the aim of vaccinating at least 70 percent of adults at least partially by Independence Day, and with a personal appeal to all those who were not vaccinated: “That is Your decision. It’s life and death. “

After three months of tackling supply and distribution bottlenecks, the Biden government faces a problem the president deemed inevitable: many of those most likely to want to be vaccinated have already done so. Vaccination sites in stadiums that were once filled with truckloads of people looking for shots are closing, stating that once they ask for more vaccines, they won’t be able to use all of the doses the federal government wants to ship to them.

However, the government’s own health experts say an additional ten million Americans will need to be vaccinated before the infection rate is low enough to return to what many people consider normal life.

The administration now wants tens of thousands of pharmacies for people to take pictures. It has also ordered pop-up and mobile clinics, especially in rural areas, and plans to allocate tens of millions of dollars to outreach workers in the community to provide transportation and organize childcare for those in high-risk neighborhoods who are want to be vaccinated.

To build confidence in vaccines, federal officials plan to enlist the help of family doctors and other envoys who have trusted voices in their communities.

In a new effort to balance supply and demand, federal officials announced Tuesday that this vaccine would be considered part of a federal pool available to other states who so choose if they don’t get theirs in a given week would order full dose distribution to order more. So far, if states have not been able to order all of their allotted doses on a population basis, they could carry over that supply to the next week.

Mr Biden also announced a new federal website and phone number that will help people find the closest vaccination site. “We will make it easier than ever to get vaccinated,” he promised.

The government is hoping for a surge in vaccinations if the Food and Drug Administration approves the use of the Pfizer BioNTech vaccine for adolescents ages 12-15 as expected early next week. The president said adolescents are important in fighting the virus because while they are not as susceptible to serious illnesses, they can still get sick and infect others.

Experts say the United States may never achieve herd immunity. At this point the virus dies because there are no hosts to transmit it. And the president suggested the nation was still a long way from defeating the pandemic.

While the vast majority of seniors have been vaccinated, “we are still losing hundreds of Americans under 65 every week,” Biden said. “And many more get seriously ill at the same time from long distances.” He warned that the nation would vaccinate people in the fall.

Still, the president said that if 70 percent of the nation’s adults have had at least one vaccine by July 4th, “Americans will have taken a serious step toward a return to normal.”

To get there, the government needs to shift the focus from mass vaccination sites to doctor’s offices, pharmacies and other local facilities, and make a far more concerted effort to reach those who are reluctant to take pictures or just find out it’s too much trouble.

“We will move on,” said the president, optimistic that “most people will be convinced of the fact that their failure to receive the vaccine can lead to other people becoming sick and possibly dying.”

Updated

May 4, 2021, 3:12 p.m. ET

As of Tuesday, more than 106 million people in the United States were fully vaccinated and more than 56 percent of adults – or nearly 148 million people – had received at least one shot. This has contributed to sharp falls in infections, hospitalizations and deaths across all age groups, federal officials said.

Despite a flood of available doses, the rate of vaccination has dropped significantly in the past two and a half weeks. According to the Centers for Disease Control and Prevention, providers are currently delivering an average of about 2.19 million doses per day, down about 35 percent from the high of 3.38 million on April 13.

Mr Biden called for 160 million adults to be fully vaccinated by July 4 – an increase of 55 million people, or more than 50 percent. About 35 million more adults would have to get at least one shot to reach the president’s target of 70 percent of adults who are at least partially protected. While this next phase of the vaccination effort is “easier because I don’t have to put this massive logistical effort together,” said Mr Biden, “in the other sense it is more difficult, it is beyond my personal control.”

When asked if the United States would help other countries that are worse off, the president promised that by July 4th his administration will have “sent about 10 percent of what we have to other nations.” It wasn’t clear whether he was referring only to doses of AstraZeneca that are not approved for sale in the U.S. or to the country’s entire vaccine inventory. He also promised to act quickly “to get as many doses as possible from Moderna and Pfizer and export them around the world”.

So far, White House officials have stuck to formulas that assign vaccine doses to states by population and have been extremely reluctant to send doses of approved vaccines overseas. The government had been unwilling to move doses to states that could administer it faster, fearing that rural areas or underserved communities would lose to urban or richer areas where residents were more willing to get shots.

As the pace of vaccination slows down, officials have decided that the benefits of a loose system outweigh this risk.

States that want more than their allotment can ask for up to 50 percent more doses, officials said. States that do not claim all of their doses a week will not be penalized and will be able to claim their full allocations the next week, officials said.

The postponement makes little difference to some states that routinely obtained as many doses as the federal government was willing to ship. But it could help some states that can use more than the federal government has shipped.

White House press secretary Jen Psaki said Tuesday the move would give governors more flexibility. “Just a few weeks ago,” she said, “we were at a different stage in our vaccination efforts when supplies were more limited and states largely ordered at or near their full allotment.”

Virginia is a case in point. Last week, for the first time, the state didn’t order every dose it could have, said Dr. Danny Avula, the state vaccination coordinator.

Now he said, “If we can find ways to vaccinate a few people at a time, supply will exceed demand across the state, and work will be much slower and more difficult.” Dr. Avula said the change will “be very helpful to the few states that still have localized areas of high demand.”

Low demand states like Arkansas may find their allotted doses shipped to an alternate location. Arkansas has so far only used 69 percent of the doses it has been given, data shows. Last week, a health ministry spokeswoman said the state had not ordered cans from the federal government. Just over a third of Arkansas adults have received at least one dose, one of the lowest in the country.

Ms. Psaki said the government is working with states to find out which settings make the most sense at this point in the vaccination campaign.

“We’re constantly evaluating the best delivery mechanisms,” she said, “and if something isn’t the most effective, we will make changes.”

Mr Biden suggested that general practitioners and pediatricians play a key role in promoting the vaccination program, as do other community figures. If the Pfizer vaccine is approved for teenagers, the administration plans to make it immediately available to them in about 20,000 pharmacies that participate in the federal vaccination program.

However, some cans are being shipped direct to pediatricians so “parents and their children can talk to their GP and get the shot from a provider they trust most,” the president said. Dr. Vivek Murthy, the surgeon general, said last week that “80 percent of people who try to decide on a vaccine say they want to speak to their doctor about that decision – and we heard that loud and clear. ”

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Elizabeth Holmes reappears in courtroom as attorneys spar

Elizabeth Holmes reappears in court as attorneys spar

Former Theranos CEO Elizabeth Holmes ahead of a hearing in her criminal trial on May 4, 2021.

CNBC

A pregnant Elizabeth Holmes appeared in court for the first time in 15 months for three days to pave the way for her fraud trial.

At Tuesday’s session in the San Jose Federal Court, Judge Edward Davila only allowed Holmes, her defense lawyers, and the prosecution inside. When Holmes entered the courthouse, she refused to answer questions from CNBC’s Scott Cohn.

At the more than seven-hour hearing, both sides discussed critical motions that determine what evidence the jury will hear, including how the Silicon Valley culture may have influenced Holmes’ behavior as CEO of Theranos. The company closed in 2018 after an investigation by the Wall Street Journal uncovered unproven technology and dubious business practices.

“There is an exaggeration in Silicon Valley. There will be a natural discussion about startups and how they work,” said Davila. He ruled that the defense cannot find them unfairly singled out.

Prosecutors warned the judge not to give Holmes too much space to argue that her actions are no different from those of other startups.

“I would like to warn against what the defense paints with a very broad brush when they say trade secret practices at Theranos,” said Jeff Schenk, a US assistant attorney.

A court sketch of the court appearance of former Theranos managing director Elizabeth Holmes on May 4, 2021.

Vicki Behringer licensed to CNBC

Holmes attorneys say prosecutors built a comprehensive case on anecdotal evidence. Theranos technology performed between seven and ten million tests over two years. Amy Saharia, a Holmes attorney, said the trial will be “a vast jumble of irrelevant, adverse evidence.”

She added, “We have all become very familiar with testing this year. Testing involves many different variables. What the government is offering is scientifically unrelated, finding that Theranos technology was responsible for erroneous results. Just because it happened doesn’t mean it was because of Theranos technology. “

The subjects were just a few of the more than two dozen motions the judge is expected to rule on this week.

One is a motion from Holmes to block evidence of her wealth, spending, and lifestyle from the jury. Prosecutors allege Holmes’ “desire to retain her wealth and status created a powerful motive” to continue and hide her fraud. Holmes was once considered the youngest billionaire with an estimated net worth of $ 4.5 billion.

A former Theranos executive close to Holmes told CNBC, “I don’t think Elizabeth believed that there was daylight between her and the company. She saw herself as a company.” This person asked not to be named for fear of jeopardizing future employment opportunities.

Holmes, once a media treasure who made the rounds of television and magazines, has remained a mom since being charged with nine wire fraud cases and two wire fraud conspiracy cases. The former executive told CNBC that she was “an inherently optimistic person”.

“There was such a mythology around her. And I think to some extent she recognized and accepted that.”

“Everyone who’s been paying attention has only heard really negative things about her,” said Danny Cevallos, a legal analyst with NBC News. “Your disgrace was spectacular. There will be plenty of jurors who have probably heard of Holmes, and it’s probably not good.”

The selection of the jury begins on August 31st.

“It has its core [of] Supporters, a small but supporter who, until the day she died, said she was unfairly portrayed and abused, “said the former Theranos manager.

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Pfizer Will Search Approval to Give Covid Vaccine to Youngsters

Pfizer Will Seek Approval to Give Covid Vaccine to Children

Pfizer is expected to apply to the Food and Drug Administration for emergency clearance to administer its coronavirus vaccine to children ages 2-11 in September, the company told Wall Street analysts and reporters on Tuesday during its quarterly call for profits.

The company also plans to file for full approval of the vaccine this month for people ages 16 to 85. Clinical study data on the safety of his vaccine in pregnant women should be available by early August.

The Pfizer BioNTech vaccine will be given to adults as part of an emergency clearance the companies received in December. Obtaining full FDA approval would, among other things, enable the companies to commercialize the vaccine directly to consumers. The approval process is expected to take months.

“Full approval is a welcome indicator of the continued safety and effectiveness of the Pfizer vaccine,” said Saskia Popescu, an infectious disease epidemiologist at George Mason University, in an email. It could also “build further confidence in the importance of vaccination,” she said.

The Pfizer BioNTech coronavirus vaccine was the first to receive emergency approval in the United States. Emergency permits are temporary and can be revoked once a public health emergency has ended.

Full approval would allow the vaccine to stay in the market when the pandemic wears off. This can also make it easier for businesses, government agencies, schools, and other institutions to request a vaccination. For example, the University of California and California State University school systems have announced that after coronavirus vaccines are fully FDA approved, students, faculties, and staff will need to be vaccinated. The U.S. military, where many troops have turned down coronavirus vaccines, has said it wouldn’t make them mandatory as long as they only have an emergency permit.

The FDA is expected to issue emergency approval early next week to allow the vaccine to be used in children ages 12-15.

White House press secretary Jen Psaki said at a news conference Tuesday that she does not want to be ahead of the FDA but that the government is preparing to “make this available to additional, younger populations.”

Dr. Popescu said the opportunity to allow children in the United States to use the vaccine was both exciting and frustrating. “We have key people around the world who cannot get vaccines and countries that may not have access for a year or more, so we need to add global access to this conversation,” she said.

As of Tuesday, more than 131 million doses of the Pfizer BioNTech vaccine had been administered in the US, according to the Centers for Disease Control and Prevention. They make up just over half of all doses administered in the country to date.

Pfizer’s managing director, Dr. Albert Bourla said the company reached out to the FDA on Friday with new data to convince the agency that the vaccine can be stored at refrigerator temperatures and not frozen for up to four weeks. Currently the limit is five days. He said the company was working on an updated version of the vaccine that could potentially be refrigerated for up to 10 weeks and hoped to have supportive data for that by August.

Rebecca Robbins contributed to the coverage.

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Pfizer expects aged, these with well being circumstances to be first

Pfizer expects elderly, those with health conditions to be first

A healthcare worker hands the Pfizer / BioNTech vaccine to Norman G. Einspruch, 88, a cardiology patient, on Dec. 30, 2020, as part of the COVID-19 vaccination schedule for seniors at Jackson Memorial Hospital in Miami, Florida, United States.

Marco Bello | Anadolu Agency | Getty Images

High-risk groups such as the elderly and those with underlying diseases are expected to be the first to receive booster shots of the Pfizer-BioNTech Covid-19 vaccine, the company’s chief scientist told investors on Tuesday.

The two-dose vaccine has been shown to be around 95% effective against Covid two weeks after the second dose, although researchers who helped develop the shot are now saying they are starting to see the strong protection with as time wanes.

Pfizer and BioNTech executives previously told CNBC that people will likely need a booster shot or third dose of the Covid-19 vaccine within 12 months of being fully vaccinated. They also said that people are likely to have to take extra shots every year.

During a call for earnings on Tuesday, Mikael Dolsten, Pfizer’s chief scientist, said it made sense to start with those who are most vulnerable, like older adults, and with chronic illnesses that make them more prone to serious illness and hospitalization like cardiovascular Diseases or cardiovascular diseases make asthma.

“We can’t predict what the CDC and FDA will do,” he added.

Dolsten’s comment comes after the company reported that the sale of its Covid-19 vaccine improved its first quarter financial results.

The company now expects total annual sales of the vaccine to be $ 26 billion, compared to its previous forecast of approximately $ 15 billion. Adjusted pre-tax profit in the high sales range of 20% is expected for the vaccine.

“Based on what we’ve seen, we believe continued demand for our Covid-19 vaccine, similar to that of the flu vaccines, is a likely outcome,” said Albert Bourla, CEO of Pfizer, to investors on the winning bid.

Should Americans need booster vaccinations, the US government would likely need to reach agreements with drug manufacturers to provide additional doses and make plans to distribute vaccines.

Last month Andy Slavitt, senior advisor to President Joe Biden’s Covid Response Team, said the White House was preparing for the potential need for Covid-19 vaccine booster shots. He said the Biden government was considering the need for extra doses.

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With Covid Vaccines for Teenagers and Youngsters, Timing Issues

With Covid Vaccines for Teens and Kids, Timing Matters

“In the end, this will be very good for vaccines as so much emphasis has been placed on the process, safety and verification,” said Dr. Campbell.

“I don’t think people in the past have realized how closely they look at the response to a vaccine,” said Dr. Campbell, or how much attention is paid to the timing, dose, and immune response of a new vaccine, is tested.

When it comes to the Covid vaccines, Dr. Maldonado: “We are not unduly concerned about anything about this vaccine, we are just following normal processes.”

Still, it’s possible that younger children, who usually have more robust immune systems than adults, may be more responsive to the Covid vaccines. For this reason, vaccine studies in children carefully examine dosage and immunological reactivity. Dr. Beers said, “They often start with a smaller group, give a lower vaccine dose, test the response, and work their way up to the dose necessary for an appropriate dose of immunity.”

Dr. Campbell and his colleagues in Maryland are just starting their first study of Covid vaccines in children under the age of 12. And no one should try to convince parents that the vaccines are safe and effective in this age group until the data are available: “I have no reason to believe that they are not safe and effective, but the evidence is in Pudding – I want to see the pudding. “

It makes sense to convince children of their regular vaccinations as it will protect them well if other diseases flare up after the pandemic lowered the rate of usual childhood vaccinations. Doctors are concerned about a whole list of vaccine-preventable diseases, including measles, whooping cough, meningitis, HPV, and flu.

Do Covid vaccines eventually fit into the routine vaccination schedule for children, and if so, at what age? Since the new vaccines are still in an emergency approval phase: “Nobody has answers; We have to see the passage of time, ”said Dr. Maldonado.

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Pfizer PFE earnings Q1 2021

Pfizer's Covid vaccine approved by FDA for emergency use

A woman holds a small bottle that reads “Coronavirus COVID-19 Vaccine” and a medical syringe in front of the Pfizer logo displayed in this image dated October 30, 2020.

Given Ruvic | Reuters

Pfizer announced on Tuesday that it would apply to German drug manufacturer BioNTech for full US approval of its Covid-19 vaccine at the end of this month. If the FDA signs out, the company can market the shot directly to consumers.

When it released its first quarter financial results, the company reported first quarter sales of $ 3.5 billion on its Covid-19, generating profits and sales that exceeded Wall Street expectations.

According to Refinitiv’s average estimates, Pfizer has outperformed Wall Street expectations as follows:

  • Adjusted EPS: 93 cents per share compared to 77 cents expected
  • Revenue: $ 14.58 billion versus $ 13.51 billion expected

The company now expects total annual sales of the vaccine to be $ 26 billion, compared to its previous forecast of approximately $ 15 billion.

Pfizer shares rose 1.4% after the news.

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Biden Confronts Coronavirus Vaccine Patents

Biden Confronts Coronavirus Vaccine Patents

WASHINGTON – President Biden is under increasing pressure from the international community and his party’s left flank to improve vaccine supplies by easing the protection of patonavirus vaccines through patents and intellectual property in the face of the escalating Covid-19 crisis in India and South America commit.

Pharmaceutical and biotech companies, which were also under pressure, tried on Monday to prevent such a move, which could detract from future profits and jeopardize their business model. Pfizer and Moderna, two major vaccine manufacturers, each announced steps to expand the supply of vaccines around the world.

The issue came to a head when the General Council of the World Trade Organization, one of its highest decision-making bodies, met on Wednesday and Thursday. India and South Africa are pressing for the panel to renounce an international intellectual property treaty protecting the trade secrets of pharmaceuticals. The United States, Britain and the European Union have so far blocked the plan.

In the White House, the president’s health advisors admit they’re divided. Some say Mr. Biden has a moral imperative to act and that it is bad policy for the president to side with the pharmaceutical executives. Others say spilling closely guarded but highly complex trade secrets would do nothing to expand the global vaccine supply.

Having the prescription for a vaccine doesn’t mean a drug company could make it, especially not quickly, and opponents argue that such a move would harm innovation and entrepreneurship – and harm America’s pharmaceutical industry. Instead, it is said, Mr. Biden can address global needs in other ways, such as by urging companies that own patents to donate large quantities of vaccines or sell them at cost.

“That would be a terrible precedent for the industry,” said Geoffrey Porges, an analyst at investment bank SVB Leerink. “It would be extremely counterproductive in the extreme because what it would tell the industry is, ‘Don’t work on something that is really important to us because if you do, we’ll just take it away from you. ‘”

Dr. Anthony S. Fauci, Mr. Biden’s senior medical advisor for the pandemic, said in an interview Monday that drug manufacturers must act themselves, either by significantly expanding their manufacturing capacity to serve other nations at “an extremely reduced price” , or by transferring their technology to make cheap copies in the developing world. He said he was agnostic about giving up.

“I always respect the needs of companies to protect their interests in order to keep them in business, but we cannot do this fully if we don’t allow life-saving vaccines to get to the people who need them,” said Dr. Fauci, adding, “You can’t let people around the world die because they don’t have access to a product that rich people have access to.”

For Mr Biden, the surrender debate is both a political and a practical issue. As a presidential candidate, he promised liberal health activist Ady Barkan, who suffers from amyotrophic lateral sclerosis (ALS), that he would be “absolutely positive” for technology sharing and access to a coronavirus vaccine if the US developed one first. Activists plan to remind Mr. Biden of this pledge during a rally scheduled for Wednesday in the National Mall.

“He’s not brave about this,” said Gregg Gonsalves, a Yale epidemiologist who fought similar battles during the AIDS crisis of the 1980s and 1990s and is expected to speak at the rally. “That’s what you said during the AIDS epidemic. Still, the same excuses come from 20 years ago. “

India and South Africa’s proposal would exempt World Trade Organization member countries from enforcing some patents, trade secrets or pharmaceutical monopolies under the agency’s trade-related intellectual property agreement known as TRIPS. The idea would be to allow pharmaceutical companies in other countries to make or import cheap generic copies.

Proponents say the waiver would allow innovators in other countries to pursue their own coronavirus vaccines without fear of patent infringement lawsuits. They also note that the proposed waiver goes beyond vaccines to include intellectual property for therapeutics and medical supplies.

“A lot of people say, ‘Don’t you need the secret recipe? “That’s not necessarily the case,” said Tahir Amin, founder of the Drugs, Access and Knowledge Initiative, a nonprofit dedicated to eliminating health inequalities. “There are companies that feel they can do it on their own, provided they don’t have to look over their shoulder and feel like they are taking over someone’s intellectual property.”

The pharmaceutical industry counters that withdrawing intellectual property protection would not help boost vaccine production. It is said that other issues around the world act as barriers to shooting up, including access to raw materials and distribution challenges in the field.

Updated

May 3, 2021, 8:53 p.m. ET

Just as important as the right to manufacture a vaccine is the technical expertise that must be provided by vaccine developers like Pfizer-BioNTech and Moderna – a process known as technology transfer.

Sharon Castillo, a Pfizer spokeswoman, said the company’s vaccine required 280 components from 86 suppliers in 19 countries. They also need highly specialized equipment and employees as well as complex and time-consuming technology transfers between partners and global supply and manufacturing networks.

“We just find it unrealistic to believe that doing without it makes startup easier so quickly that the supply problem can be addressed,” she said.

On Monday, Pfizer CEO Albert Bourla announced on LinkedIn that his company will donate over $ 70 million worth of drugs to India immediately and is also trying to expedite the vaccine approval process in India. The company also posted on Twitter promising “the greatest humanitarian relief effort in the history of our company to help the people of India”.

Moderna, which developed its vaccine with US taxpayer funding, has already announced that it will “not enforce our patents related to Covid-19 against those who make vaccines to fight the pandemic.” But activists are not only calling for a waiver, but also for companies to share their expertise in setting up and running vaccine factories – and for Mr. Biden to rely on it.

More than 170 former heads of state and Nobel Prize winners last month, including Gordon Brown, the UK’s former Prime Minister; Ellen Johnson Sirleaf, the former President of Liberia; and François Hollande, the former President of France, issued an open letter asking Mr Biden to support the proposed waiver.

On Capitol Hill, 10 Senators, including Bernie Sanders, independent of Vermont, and Elizabeth Warren, Democrat of Massachusetts, urged Mr. Biden to “give people priority over pharmaceutical company profits” and to reverse the Trump administration’s opposition to renunciation . More than 100 House Democrats have signed a similar letter.

“This is one of the most important moral questions of our time,” said Representative Ro Khanna, Democrat of California. “Denying other countries the ability to make their own vaccines is just cruel.”

Katherine Tai, Mr. Biden’s sales representative, has held more than 20 meetings in the past few weeks with various stakeholders – including global health activists, pharmaceutical executives, members of Congress, Dr. Fauci and the philanthropist Bill Gates – to find a way forward.

“Ambassador Tai reiterated that the Biden Harris administration’s top priority is to save lives and end the pandemic in the United States and around the world,” Ms. Tai’s office said in a carefully worded statement Monday after she had spoken about the proposed waiver with the government director-general of the World Intellectual Property Organization, an arm of the United Nations.

In a letter to Ms. Tai last month, the Biotechnology Innovation Organization, a trade group, warned against licensing other countries – some of them our economic competitors – to undermine our world-leading biotechnology base, export jobs overseas, and undermine incentives to invest in such technologies in the future. “

One of the pharmaceutical industry’s concerns about a patent waiver for coronavirus vaccines is that a precedent could be created that undermines intellectual property protection for other drugs that are central to making money.

“The pharmaceutical industry is extremely protective of its intellectual property,” said Dr. Aaron Kesselheim, Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital. “This kind of violent resistance is a reflex from the pharmaceutical industry.”

However, it is not seen that such a move would have any impact on intellectual property protection for other treatments after the coronavirus crisis ended in the particular circumstances of the pandemic, industry researchers said.

In the 2000s, a handful of governments, including the Brazilian and Thai, bypassed patents of the developers of antiviral drugs for HIV / AIDS, paving the way for lower-cost versions of the treatments.

However, HIV drugs involve a much simpler manufacturing process than the coronavirus vaccines, especially those using messenger RNA technology that have never been used in an approved product.

On a Twitter thread, Mr. Amin offered another example: In the 1980s, Merck and GlaxoSmithKline had developed recombinant hepatitis B vaccines and had a monopoly of more than 90 patents on manufacturing processes. The World Health Organization recommended vaccination for children, but it was expensive – $ 23 per dose – and most Indian families couldn’t afford it.

The founder of Shantha Biotechnics, an Indian manufacturer, was told that “even if you can afford to buy the technology, your scientists cannot in the least understand the recombinant technology,” wrote Amin.

But Shantha, he added, went on to “make India’s first homegrown recombinant product for $ 1 a dose”. This enabled UNICEF to run a mass vaccination campaign.

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WHO is carefully monitoring 10 Covid variants as virus mutates world wide

WHO is closely monitoring 10 Covid variants as virus mutates around the world

Mukesh Bhardwaj cries as he sits next to his wife, who is receiving free oxygen support for people with respiratory problems, outside a Gurudwara (Sikh temple) amid the spread of coronavirus disease (COVID-19) in Ghaziabad, India. May 3, 2021.

Adnan Abidi | Reuters

The World Health Organization is tracking 10 variants of coronavirus “of concern” or “worrying” around the world, including two that were first discovered in the US and one triple mutant that is wreaking havoc in India as a potential global threat to the world public health.

New strains of Covid-19 emerge every day as the virus continues to mutate, but only a handful make the WHO official watch list an “variant of interest” or the more serious term “variant of concern” which is commonly defined as a mutated strain that is more contagious, more deadly, and more resistant to current vaccines and treatments.

The organization has identified three strains as variants of concern: B.1.1.7, which was first detected in the UK and is currently the most common strain in the US; B. 1.351, detected for the first time in South Africa, and the P.1 variant, detected for the first time in Brazil.

An interesting variant is the B.1617 variant or the triple mutated strain that was first found in India. However, WHO technical lead on Covid-19, Maria Van Kerkhove, said more studies are needed to fully understand its significance.

“There are actually a number of virus variants that are being discovered around the world and that we must all properly assess,” said Van Kerkhove. Scientists are studying how much each variant circulates in local areas, whether the mutations change the severity or transmission of the disease, and other factors, before being classified as a new public health threat.

“The information comes quickly and furiously,” she said. “There are new variants being identified and reported every day, not all of which are important.”

Other variants classified as variants of interest include B.1525, which was first detected in the UK and Nigeria; B.1427 / B.1429, recorded for the first time in the USA; P.2, first discovered in Brazil; P.3, first discovered in Japan and the Philippines; S477N, first detected in the USA, and B.1.616, first detected in France.

Van Kerkhove said the classifications are determined, at least in part, by sequencing capabilities, which vary from country to country. “It’s been really sketchy so far,” she said.

She said the agency is also viewing local epidemiologists as an extension of the agency’s “eyes and ears” to better understand the local situation and identify other potentially dangerous variants.

“It is important that we have the right discussions to determine which ones are important to the public health value. This means that doing so changes our ability to use public health social measures or any of our medical countermeasures.” , she said.

“We’re getting the right people together in the room to discuss what these mutations mean,” she said. “We need the global community to work together, and they are.”

The Centers for Disease Control and Prevention also have a list of four variants of interest and five variants of concern that is similar to the WHO list, although the CDC mainly focuses on variants that are causing new outbreaks in the United States.

Van Kerkhove said a number of countries “have some worrying trends, some worrying signs of rising case numbers, increasing hospitalization rates and increasing ICU rates in countries that do not yet have access to the vaccine and that have not achieved the required levels of coverage.” really having these effects on serious illness and death and transmission. “

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FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Subsequent Week

FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

WASHINGTON – The Food and Drug Administration is preparing to approve the use of the Pfizer BioNTech coronavirus vaccine in adolescents ages 12-15 by early next week, according to federal officials familiar with the agency’s plans, and opens the US vaccination campaign to millions more people.

Some parents have counted down the weeks since Pfizer announced results of its teenage study showing the vaccine was at least as effective in this age group as it was in adults. Vaccinating children is key to increasing immunity in the population and reducing the number of hospitalizations and deaths.

The approval in the form of an amendment to the existing emergency approval for the Pfizer vaccine could come as early as later this week. If so, the Centers for Disease Control and Prevention’s vaccine advisory board is expected to meet the following day to review the clinical trial data and make recommendations on the use of the vaccine in adolescents.

The enlargement would be a major development in the country’s vaccination campaign and welcome news for some parents looking to protect their children during summer activities and before the start of the next school year. This is also another challenge for policy makers who have difficulty vaccinating a large percentage of adults who are reluctant to get the shot. Many more may refuse to vaccinate their children.

Pfizer reported a few weeks ago that none of the adolescents in the clinical trial who received the vaccine developed symptomatic infections, a sign of significant protection. The company said volunteers produced strong antibody responses and had roughly the same side effects seen in people aged 16-25.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, said she was unable to comment at the time the agency made the decision.

“We can assure the public that we are working to look into this request as quickly and transparently as possible,” she said.

Over 100 million adults in the US have been fully vaccinated. However, approval would come in the middle of a delicate and complex push to reach the 44 percent of adults who have not yet received a single shot.

With much of the world demanding the surplus of US-made vaccines, the use of the Pfizer BioNTech shot in adolescents will also raise questions about whether care should be targeted at an age group largely spared heavy vaccines seems Covid19.

“I think we need to have a national and global conversation about the ethics of our vaccinated children, who are at low risk of serious complications from the virus, when there aren’t enough vaccines in the world to protect high-risk adults from dying “Said Jennifer B. Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

Updated

May 3, 2021, 8:53 p.m. ET

President Biden has come under increasing pressure to shed some of the country’s vaccine supplies. Some federal officials have also urged the government to decide soon how much vaccine is needed so that the doses do not expire or be shipped to the states and not used. The federal government has bought 700 million doses of three state-approved vaccines to be dispensed before the end of July, well in excess of what would be required for any American.

White House officials said last week that the intention is to make up to 60 million doses of the AstraZeneca vaccine available to other countries as long as federal regulators deem the doses to be safe. The vaccine has not yet been approved by American regulators. However, global health groups and public health experts said engagement was not enough.

Dr. Rupali J. Limaye, a Johns Hopkins University researcher investigating vaccine use and reluctance, said the United States should donate any surplus Pfizer BioNTech shots – and any surpluses from other manufacturers – to India and other countries that are had severe outbreaks and asked for help.

“From an ethical point of view, we shouldn’t give people like them priority over people in countries like India,” said Dr. Limaye about teenagers.

If the United States continues its supply of Pfizer-BioNTech, it should be reserved for adults while health officials grapple with the phase of the vaccination campaign that requires more individualized local contact.

“We still have to move past hesitant adults and start at the same time maybe 14 or 15,” said Dr. Limaye. “But the priority should still be adults.”

The current vaccine supply in the United States is substantial. As of Monday, about 65 million doses had been dispensed but not given, according to the CDC, including 31 million doses of the vaccine from Pfizer-BioNTech, nearly 25 million doses from Moderna, and 10 million doses from Johnson & Johnson

The Pfizer and Moderna vaccines each require two doses. Pfizer is approved for ages 16 and up, Moderna for ages 18 and over.

Dozens of millions more Pfizer BioNTech cans – about three weeks long, according to a federal official – have been made and are in various stages of readiness. They wait for the final tests before they are shipped.

Moderna expects results from its own clinical study in adolescents aged 12 to 17 years old soon, followed by results in children aged 6 months to 12 years later this year.

The approval of the Food and Drug Administration should ease the concerns of middle and high school administrators scheduled for the fall. If students can be vaccinated by then, it could lead to more normal gatherings and allow administrators to plan further ahead in the academic year.

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New Jersey to present free beer to Covid vaccine recipients

New Jersey to give free beer to Covid vaccine recipients

New Jersey Governor Phil Murphy speaks at a press conference after touring the vaccination site at the New Jersey Convention and Exposition Center Covid-19 in Edison, New Jersey on January 15, 2021.

Mark Kauzlarich | Bloomberg | Getty Images

New Jersey Governor Phil Murphy announced a new offer on Monday to promote coronavirus vaccinations: get your first dose in May and get a free beer.

“We’re not going to be afraid to try new things,” said Murphy as he presented the new program, called “Shot and a Beer”, at a press conference.

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Thirteen New Jersey-based breweries are participating in the program, which Murphy says is only available to citizens 21 and older.

These New Jerseyers must show their vaccination cards as evidence before receiving their reward, the Democratic governor said.

The breweries themselves pay for the cost of the free drinks, said Murphy, who suggested that more beer makers could be added to the list soon.

The breweries currently participating are: Battle River Brewing, Bradley Beer Project, Bolero Snort Brewing Company, Brix City Brewing Company, Carton Brewing Company, Flounder Brewing Company, Flying Fish Brewing Company, Gaslight Brewery and Restaurant, Hackensack Brewing Company, Kane Brewing Company, Little Dog Brewing Company, Magnify Brewing Company, and River Horse Brewing Company.

The program came from the New Jersey Department of Health in association with the Brewer’s Guild of New Jersey.

The Garden State is hardly the first to suggest an incentive for people to get vaccinated.

West Virginia Republican Governor Jim Justice announced an initiative last week to give $ 100 savings bonds to younger citizens who get vaccinated.

Connecticut has its own alcoholic incentive with its “Drinks On Us” campaign: residents who get fully vaccinated and show their vaccination cards at certain restaurants will receive a free drink between May 19 and 31.

Incentive or no, vaccination rates are increasing. More than 29% of the US population is fully vaccinated, and cases and deaths from Covid are declining, according to Johns Hopkins University.

But a significant number of Americans say they are not ready to get vaccinated. A survey by Monmouth University published in mid-April found that roughly one in five Americans said they didn’t get the shot.

This is causing health officials and leaders at all levels of government to urge more people to seek and get their vaccinations.

The “Shot and a Beer” campaign is just part of New Jersey’s broader programs aimed at bringing the state back to a more normal summer as the fight against the pandemic continues.

Murphy announced the free beer plan after detailing the “Grateful for the Shot” initiative, which allows parishioners to walk straight to vaccination sites from church services.

It’s “maybe on the other end of the spectrum” of incentives, Murphy said.