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Three Males Are Accused in Scheme to Promote Covid-19 Vaccines

Three Baltimore men were accused by federal prosecutors of setting up a fake website to sell Covid-19 vaccines for $ 30 a dose.

The men, Olakitan Oluwalade, 22, and Odunayo Baba Oluwalade, 25, who are cousins, and Kelly Lamont Williams, 22, are charged with conspiracy for wire fraud, the US District Attorney’s Office said on Thursday.

Prosecutors said the men created a website similar to that of Moderna, the Cambridge, Massachusetts-based biotechnology company, which received federal approval in December to distribute its Covid-19 vaccine.

The real website is modernatx.com, and the website created by the men that authorities have since confiscated was modernatx.shop. Prosecutors said the fake domain’s source code revealed that the creator used a tool to copy the real Moderna website.

“The logo, the markings, colors and texts on the fake domain were visually similar,” said a statement from the company’s actual homepage. But prosecutors said the bogus website had an addition, “You might be able to purchase a COVID-19 vaccine in advance,” with a link to “Contact Us.”

The men were caught after an undercover agent contacted the number on the fake website on Jan. 11 and completed a transaction for 200 doses of the vaccine for $ 6,000. Officials said the three men never had any cans.

The agent was ordered to transfer half of the funds to Mr. Williams’ account with the Navy Federal Credit Union. By January 15, agents had confiscated the fake domain and ransacked Mr. Williams’ home.

Investigators found texts between Mr. Williams and the cousins ​​discussing the system, according to court documents.

An agent used Mr. Williams’ phone to send a message to Odunayo Baba Oluwalade and sent some of the money from the exchange to the cousins, prosecutors said. Her two houses were also soon searched.

It was unclear how much money the men had cheated. A spokeswoman for the US law firm said Friday that she could not provide any further details on the charges than stated in the statement.

A representative from Moderna could not be reached immediately on Friday.

A lawyer, Richard Bardos, said he had been assigned to the Odunayo Baba Oluwalade case but declined to comment further, referring to a Maryland law prohibiting lawyers from speaking about ongoing cases.

Jonathan Van Hoven, a lawyer for Mr. Williams, declined to comment. The Maryland District Attorney’s Office said Olakitan Oluwalade has not yet been assigned a lawyer.

“As the public searches for vaccines to protect themselves and their families from Covid-19, scammers wait to take advantage of their desperation,” said James R. Mancuso, a special agent for Homeland Security Investigations. “We want to remind the public to exercise extreme caution online, especially when it comes to Covid-19 vaccines, treatments and protective equipment.”

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Covid Vaccines for Children Are Coming, however Not for Many Months

Since adults are at high risk of Covid-19 being immunized against the coronavirus, many parents want to know: When will my child be vaccinated?

The short answer: not until late summer.

Pfizer and Moderna have enrolled children ages 12 and older in clinical trials with their vaccines and hope to see results by the summer. Depending on the performance of the vaccines in that age group, companies may then test them on younger children. It usually takes the Food and Drug Administration a few weeks to review data from a clinical trial and approve a vaccine.

Three other companies – Johnson & Johnson, Novavax and AstraZeneca – are also planning to test their vaccines in children, but are further behind.

When researchers first test drugs or vaccines in adults, they usually move down in age bracket, looking for changes in the effective dose and unexpected side effects.

“It would be quite unusual to start early with children,” said Dr. Emily Erbelding, an infectious disease doctor at the National Institutes of Health who oversees the testing of Covid-19 vaccines in specific populations.

Some vaccines – such as those that protect against pneumococcal or meningococcal bacteria, or rotavirus – were first tested in children because they could help prevent pediatric diseases. However, it made sense to test coronavirus vaccines in adults first and approve them for adults because the risk of serious illness and death from Covid-19 increases sharply with age, said Paul Offit, professor at the University of Pennsylvania and a member of the FDA vaccine advisory body.

“We’re trying to save lives, keep people out of intensive care and keep them from dying,” said Dr. Offit. That means prioritizing vaccines for the oldest people and for those with underlying diseases.

People under the age of 21 make up about a quarter of the population in the United States, but they account for less than 1 percent of deaths from Covid-19. Still, about 2 percent of children who get Covid-19 require hospital care, and at least 227 children in the United States have died from the disease.

“It’s a significant disease in children, just not necessarily when compared to adults,” said Dr. Kristin Oliver, pediatrician and vaccine expert at Mount Sinai Hospital in New York.

Children also need to be vaccinated so the United States can move closer to herd immunity – the long-promised target where the pandemic will stall because people run out of virus to infect.

Scientists have estimated that 70 to 90 percent of the population may need to be immunized against the coronavirus in order to achieve herd immunity, especially with contagious variants that are expected to be widespread in the country.

“Not all adults can get the vaccine because there is some reluctance, or there may even be a vulnerable immune system that just doesn’t respond,” said Dr. Erbelding. “I think we need to involve children if we are to achieve herd immunity.”

Immunizing children in racial and ethnic groups most affected by the pandemic will also be important, she added.

Pfizer and Moderna’s adult clinical trials each enrolled approximately 50,000 participants. They had to be large enough to show significant differences between the volunteers who received a vaccine and those who received a placebo. However, since it is less common for children to become seriously ill with Covid-19, such planning of experiments in children would not be feasible as many more participants would be required to show an effect.

Updated

Apr. 11, 2021 at 11:13 am ET

Instead, the companies will screen vaccinated children for signs of a strong immune response that would protect them from the coronavirus.

The Pfizer BioNTech vaccine was approved in December for people aged 16 and over. The company has continued its study with younger volunteers, recruiting 2,259 teenagers between the ages of 12 and 15. According to the Centers for Disease Control and Prevention, teenagers are roughly twice as likely to be infected with the coronavirus as younger children.

The results of this study should be in by the summer, said Keanna Ghazvini, a Pfizer spokeswoman.

“Getting under 12 will require a new study and possibly a modified formulation or dosage schedule,” said Ms. Ghazvini. These studies will most likely begin later in the year, but the plans will be final after the company has data from older children, she added.

Moderna’s vaccine, also approved in December, is on a similar path for pediatric testing. In December, the company began testing teenagers ages 12-17 and plans to add 3,000 volunteers to that age group. The company expects results “around mid-2021,” said Colleen Hussey, a spokeswoman for Moderna.

Based on the results, Moderna plans to study the vaccine in children between the ages of 6 months and 11 years of age later this year.

Infants may have some antibodies from vaccinated or infected mothers at birth, but the mother’s protection is unlikely to last until the age of one. And with their relatively weak immune systems, babies may be particularly susceptible to infection when community transmission is high.

The studies will also evaluate the safety of the vaccine in children – and hopefully alleviate any parents’ fears. A third of adults in the United States said they have no plans to immunize their children against the coronavirus, according to a recent survey by Verywell Health.

Given the low risk of Covid-19 in children, some parents may be skeptical of the urgency to vaccinate their children with a brand new burst, said Dr. Offit. “Because of this, the vaccine should be kept on a very high safety standard,” he said.

To date, more than 42 million people in the US have been vaccinated with few permanent side effects. And the FDA has several systems in place to carefully monitor serious reactions to the vaccine.

“You’re really, really looking at the data,” said Dr. Oliver. “As a pediatrician and a mother, I have really good faith that these systems will work.”

Once a vaccine is available for children, schools can reintroduce extracurricular activities that involve close contact, such as band exercises, team sports, and choirs. However, in the meantime, there is ample evidence that schools can reopen with other precautions, said Dr. Oliver.

“I don’t think we have to expect a vaccine to open schools in the fall,” she said. “We should now plan to open schools.”

Dr. Oliver also urged parents to ensure that children are immunized against other diseases. According to the CDC, orders for vaccines for children without the flu under the Childrens Vaccines program fell by a total of around 10.3 million doses.

“Now is the time to really catch up on missed doses of these vaccines,” she said. “Measles, HPV, tetanus boosters, pertussis boosters – all of these are really important.”

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With Extra Vaccines Secured, Biden Warns of Hurdles to Come

WASHINGTON – The Biden government said Thursday it had received an additional 200 million doses of coronavirus vaccines, enough to vaccinate every American adult, but President Biden warned logistical hurdles would most likely mean many Americans would still be around by the end of the year will not be vaccinated summer.

The extra doses add up to a 50 percent increase in the vaccine and give administration the number of doses Mr Biden said last month would serve 300 million people by the end of summer. But getting those shots into people’s arms will still be difficult. Both vaccines are two doses three to four weeks apart. Mr. Biden lamented the “gigantic” logistical challenge he faced while performing at the National Institutes of Health. He also openly expressed frustration with the previous administration.

“It’s one thing to have the vaccine,” said Mr Biden. “It’s another thing to have vaccines.”

The Department of Health and Human Services said Pfizer and Moderna would each provide 300 million doses in “regular increments” by the end of July.

The administration aims for a gradual process. Dr. Anthony S. Fauci, the government’s leading infectious disease expert, predicted Thursday morning that any American could look for a vaccine as early as April in an “open season” that would expand availability beyond priority categories.

“Until we get to April, I’ll call it, to put it better, the ‘open season’,” said Dr. Fauci in an interview with NBC’s “Today”. “Namely, virtually anyone and everyone in any category could start getting vaccinated.”

But the problem could be giving doses to people who aren’t readily looking for them.

Mr Biden has carefully avoided his White House being consumed by criticism of his predecessor, but on Thursday he targeted Donald J. Trump directly for saying he failed to put in place a procedure for mass vaccination. The president, who said he had promised to speak openly with Americans about the challenges of the pandemic, accused Mr Trump of creating a significant one by not overseeing the creation of an optimized vaccine distribution program. “The vaccination program was in much, much worse shape than my team and I expected,” said Biden.

“While scientists have done their job discovering vaccines in record time, my predecessor – I will be very frank about this – did not do his job to prepare for the massive challenge of vaccinating hundreds of millions,” added Biden.

“It was a big mess,” he said. “It will take time to mend to be blunt with you.”

Health officials in the Trump administration have pushed these proposals back, referring to hundreds of briefings that Department of Health and Human Services officials have offered to the incoming health team, including vaccine assignment and distribution.

The highly decentralized vaccine distribution and administration plans that give state and local health authorities authority after the doses have been dispensed were worked out with staff from the Centers for Disease Control and Prevention and the Department of Defense.

Officials involved in the last government’s distribution plans said late last year that outside of the first few weeks, when they carefully checked the flow of reserves for the second dose, they always planned to ship cans as soon as they were available, and that they never intended to store these doses.

The agreement for an additional 200 million doses of coronavirus vaccine helps fulfill a promise made by Mr Biden in January to increase the supply to cover a larger segment of the population. He said at the time that the government made this deal with the two manufacturers as part of its larger promise that around 300 million Americans would get a dose of the vaccine by the end of summer or early fall.

Updated

Apr. 11, 2021 at 9:51 am ET

On Thursday, Mr Biden said his government had “now bought enough vaccine to vaccinate all Americans”.

Dr. Nicole Lurie, who was the assistant health secretary for preparedness and response under President Barack Obama, said the hesitation of the vaccine could affect how fast some Americans who want to be vaccinated could get their shot, but that more care, more work would mean to get vaccines people.

“We’re going to reach more and more people, and more people need to make extra efforts to reach them,” she said. “One has to hope that given the growing supply, the public will still have great demand for vaccines. This is really the unknown. “

The government had already received 400 million doses of the vaccines from Pfizer and Moderna, the two companies approved for emergency distribution – doses expected by the end of June. Mr Biden said Thursday that companies would now ship them by the end of May.

A third manufacturer, Johnson & Johnson, has asked the Food and Drug Administration to approve its single-dose emergency vaccine. That decision could be made by the end of the month and allow the vaccine to be distributed in the first week of March. However, the company is still trying to show that it can manufacture the vaccine on a large scale at its Baltimore facility.

Federal officials have so far refused to say how much of this vaccine will be ready for distribution once it clears regulatory hurdles, but they caution to expect a spate of new doses from Johnson & Johnson soon.

“We haven’t found that the level of manufacturing allows us to have as much vaccine as we think is necessary,” Andy Slavitt, a senior White House pandemic advisor, said recently.

To date, only about 10 percent of Americans have received at least one dose of vaccine. On Thursday, the CDC announced that about 34.7 million people had received at least one dose of a Covid-19 vaccine, including about 11.2 million people who were fully vaccinated.

The speed of vaccinations has accelerated steadily over the past few weeks. The number of daily recordings now averages 1.5 million compared to 1.1 million two weeks ago. At this rate, Mr Biden will easily fulfill his promise to vaccinate 100 million Americans in his first 100 days in office.

According to state and federal health officials, the main barrier to vaccinating more people at this time is the lack of care. The administration has been looking for a way to speed up production, including a possible breakthrough where Moderna would fill its vials with more cans and potentially get out millions more cans earlier.

However, Mr. Biden faces a variety of long-standing manufacturing constraints, including limited free space around the world to manufacture more vaccines and the delicate and complex nature of vaccine manufacturing.

White House officials have indicated that their work increases weekly vaccine supplies by 28 percent. However, these doses are due to an expected increase in manufacturing.

Unlike the previous administration, the White House pandemic team has been briefing governors on planned care in three-week increments so state health officials will better know how to plan ahead.

And they took a much more aggressive approach by using federal resources to shoot guns. The White House announced this week that it is building five new vaccination centers, including three in Texas and two in New York, specifically designed to vaccinate people of color. The government also said it plans to deliver 1 million doses of vaccine to 250 government-supported community health centers in underserved neighborhoods. A new vaccination program for federal pharmacies began this week.

And on Friday, the government announced that it would send over 1,000 active troops to Covid-19 vaccination centers across the country operated by the Federal Emergency Management Agency.

FEMA, part of the Department of Homeland Security, has announced that it will set up around 100 vaccination sites nationwide this month and spend $ 1 billion on vaccination measures, including community vaccination sites.

Sharon LaFraniere and Sheryl Gay Stolberg contributed to the coverage.

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Covid Vaccines: New Diplomacy Software for India and China

NEW DELHI – India, the unmatched vaccine producer, is dispensing millions of doses to friendly and estranged neighbors. It seeks to counter China, which has made the gun distribution a central point of its external relations. And the United Arab Emirates, which are drawing on their oil wealth, are buying pounds on behalf of their allies.

The coronavirus vaccine – one of the most sought-after products in the world – has become a new currency for international diplomacy.

Countries with the means or the know-how use the shots to find favor or to thaw frosty relationships. India sent them to Nepal, a country that has increasingly come under Chinese influence. Sri Lanka, in the midst of a diplomatic tug-of-war between New Delhi and Beijing, gets doses of both.

The strategy carries risks. India and China, both of which make vaccines for the rest of the world, have large populations of their own to vaccinate. While there is little evidence of grumbling in either country, this could change if the public watch boxes are sold or donated overseas.

“Indians are dying. Indians are still getting the disease, ”said Manoj Joshi, a distinguished contributor to the Observer Research Foundation, a New Delhi think tank. “I could understand if our needs were being met and you were giving the stuff away. But I think there is a false moral superiority that you are trying to convey where you say we give our things away even before we use them ourselves. “

Donor countries are making their offerings at a time when the United States and other wealthy nations are taking up the world’s supplies. The poorer countries are desperately trying to get their own. An inequality recently warned by the World Health Organization has brought the world “to the brink of catastrophic moral failure.”

With their health systems tested like never before, many countries are eager to take up the offer – and donors could reap good political will as a reward.

“Instead of securing a country by sending troops, you can secure the country by saving lives, saving the economy and helping with vaccination,” said Dania Thafer, executive director of the Gulf International Forum, a Washington-based think tank.

China was one of the first countries to undertake a diplomatic vaccine boost, pledging to help developing countries last year even before the nation mass-produced a vaccine that was proven effective. Just this week it was announced that it would donate 300,000 doses of vaccine to Egypt.

However, some of China’s efforts in vaccine diplomacy have stemmed from late shipments, lack of disclosure of the effectiveness of its vaccines, and other issues. Chinese government officials have cited unexpectedly strong needs at home in isolated outbreaks, a move that could mitigate any domestic backlash.

Even as Chinese-made vaccines spread, India saw an opportunity to bolster its own image.

The Serum Institute of India, the world’s largest vaccine factory, produces the AstraZeneca-Oxford vaccine at a daily rate of approximately 2.5 million doses. This pace has allowed India to distribute free cans to its neighbors. Too much fanfare, plane loads have arrived in Nepal, Bangladesh, Myanmar, the Maldives, Sri Lanka, the Seychelles and Afghanistan.

“Act eastward. Quick action ”, said the Indian Foreign Minister S. Jaishankar on Twitter the arrival of 1.5 million cans in Myanmar.

Updated

Apr. 11, 2021 at 7:21 ET

The Indian government has tried to collect promotional points for cans that have been shipped to places like Brazil and Morocco despite those countries buying theirs. The Serum Institute has also pledged 200 million doses for a global WHO pool called Covax, which would go to poorer nations, while China recently pledged 10 million.

Currently, the Indian government has room to donate overseas, even after months when cases have skyrocketed and the economy has faltered, and despite vaccinating only a tiny percent of its 1.3 billion people. One reason for the lack of setbacks: The Serum Institute is producing faster than the Indias vaccination program can currently handle, leaving extras for donations and exports.

And some Indians are in no rush to get vaccinated because they are skeptical of a native vaccine called Covaxin. The Indian government approved its use in an emergency without disclosing much data on it, causing some people to doubt its effectiveness. While the AstraZeneca-Oxford shock was less skeptical, those who are vaccinated have no choice as to which vaccine to receive.

For India, it has received a rejoinder to China for its soft-power vaccine initiative after years of making political gains for the Chinese in their own backyard – in Sri Lanka, the Maldives, Nepal and elsewhere. Beijing offered deep pockets and quick answers when it came to large investments that India, with a complex bureaucracy and a slowing economy, was struggling to achieve.

“India’s neighborhood has become more crowded and competitive,” said Constantino Xavier, who studies India’s relations with its neighbors at the Center for Social and Economic Progress, a think tank in New Delhi. “The vaccine boost strengthens India’s credibility as a reliable crisis helper and solution provider for these neighboring countries.”

One of India’s largest donations went to Nepal, where India’s relationship was at an all-time low. The tiny land between India and China is of strategic importance to both.

For the past five years, the government of CP Sharma Oli, the prime minister, has started to snuggle up to China after border disputes and what some in Nepal criticize as a master-servant relationship with India. Mr. Oli gave Xi Jinping Thought workshops based on the strategies of the Chinese leader and signed contracts for several projects under the Belt and Road Initiative, Beijing’s Infrastructure and Development Boost.

But the prime minister lost power last year. When both Chinese and Indian delegations arrived in Kathmandu to direct Nepal’s domestic jockeying, the Nepalese leader appears to have cut the temperature with India.

After Mr Oli sent his foreign minister to New Delhi for talks, India donated a million cans. China’s Sinopharm has also applied for approval of its vaccine from Nepal, but drug authorities there have not given it approval.

“The vaccine came as an opportunity to normalize relations between Nepal and India,” said Tanka Karki, a former Nepalese envoy to China.

Still, the strategy of winning hearts and minds with vaccines is not always successful.

The United Arab Emirates, which is importing vaccines faster than any other country besides Israel, has started donating Chinese-made Sinopharm vaccines to countries where it has strategic or commercial interests, including 50,000 doses each to Seychelles, the island nation in the US, Indian Ocean and Egypt, one of its Arab allies.

In Egypt, some doctors have resisted using them because they did not trust the data that the UAE and the Chinese manufacturer of the vaccine had published on studies. The government of Malaysia, one of the Emirates’ largest trading partners, declined an offer of 500,000 doses, saying regulators would need to independently approve the Sinopharm vaccine. After regulatory approval, Malaysia instead bought vaccines from Pfizer in the US, the AstraZeneca-Oxford vaccine, and a vaccine from another Chinese company, Sinovac.

Even accepted goodwill can be short-lived. Experience Sri Lanka, where India and China battle for influence.

Since Gotabaya Rajapaksa took office as president in 2019, New Delhi has struggled to get its government to commit to a contract that its predecessor signed to complete a terminal project in the port of Colombo, part of which will be developed by India should. While large Chinese projects continued, Mr Rajapaksa opened the Indian deal for review.

Indian Foreign Minister visited Jaishankar last month hoping to highlight the importance of the project. In the same month, 500,000 doses of vaccine arrived from India. Mr. Rajapaksa was at the airport to meet them. Sri Lanka has also placed an order for 18 million doses from the Serum Institute, the Ministry of Health in Colombo confirmed.

The Indian media saw both as a diplomatic victory, and it seems clear that Sri Lanka will largely depend on India for vaccines. On January 27th, Mr. Rajapaksa received another gift from China: a promise to donate 300,000 cans.

The duel donations are only part of a much larger diplomatic dance. Just a week later, Mr Rajapaksa’s cabinet decided that Sri Lanka would develop the Colombo terminal itself and force India out of the project.

Mujib Mashal reported from New Delhi and Vivian Yee from Cairo. Bhadra Sharma, Elsie Chen, Aanya Piyari, Salman Masood and Zia ur-Rehman contributed to the coverage.

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Widespread Covid vaccines will likely be accessible within the spring, says Walgreens exec

Walgreens pharmacist Jessica Sahni is preparing a Pfizer Covid-19 vaccine at The New Jewish Home long-term care facility on Manhattan’s Upper West Side in New York on December 21, 2020.

Bryan R. Smith | AFP | Getty Images

Covid vaccines are still hard to come by, but that should change by spring, said Rick Gates, senior vice president of pharmacy and healthcare at Walgreens.

“I would say the end of March and the beginning of April will be the schedule for you to have more general use of it in all of our branches across the country of pharmacies and other places where you can start vaccinations,” he said Tuesday at CNBC’s “Healthy Return” virtual event.

Walgreens is part of a federal pharmacy program that is delivering cans direct to drug stores this week. The pharmacy chain plans to start vaccinations in some of its stores in 15 states, as well as Chicago and New York City, on Friday. However, all of these pharmacies will have limited supplies and vaccines will only be available to Americans who are high priority due to factors like age or health.

On Tuesday, the Biden government announced it would also begin shipping vaccines to community health centers next week – part of their strategy to reach out to black and low-income families who may or may not have a grocery or drug store nearby other barriers have access, such as a lack of transportation.

Around 43.2 million doses of the Covid-19 vaccine were administered across the country on Tuesday morning, according to the Centers for Disease Control and Prevention. Only 9.8 million people received two doses of the shot. Both vaccines currently under emergency approval from the Food and Drug Administration – Pfizer BioNTech and Moderna vaccines – require two doses.

Gates said he was confident that a vaccine developed by Johnson & Johnson could increase supply. The drug company filed for emergency approval with the FDA last week after data was released showing its vaccine was about 66% effective against the virus. It’s a one-shot vaccine and can be stored in the refrigerator for months.

“It’s just good news for all of us that there will be more vaccines,” he said.

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US Well being Specialists: Vaccines Will Improve by Spring

Although more and more contagious variants are spreading in the US, the leading health authorities expressed optimism on Sunday that both the supply of vaccines and the vaccination rate will steadily increase.

“The demand currently significantly exceeds the supply,” said Dr. Anthony S. Fauci, the nation’s leading infectious disease doctor, on NBC’s Meet the Press program.

“I can tell you that things will get better from February through March through April because the number of vaccine doses available will increase significantly.”

The number of daily shots administered in the United States has increased recently. The Centers for Disease Control and Prevention reported that more than 2.2 million doses were given on Saturday and 1.6 million on Friday. The average for the past seven days has been 1.4 million a day, which is close to President Biden’s new target of 1.5 million shots a day.

In addition, the supply of vaccines is growing – although still well below demand. Federal officials recently increased shipments to the states to 10.5 million cans per week as Moderna and Pfizer incrementally increase production. The two companies have signed deals to provide the US with a total of 400 million doses by the summer – enough to vaccinate 200 million people.

Pfizer recently announced that it would be dispensing its doses two months ahead of schedule by May, also because an extra dose is now counted in every vial it makes. And Moderna is considering a production change that would allow it to increase the number of doses in its vials from 10 to 15.

Officials also expect the Food and Drug Administration to approve a vaccine containing a dose of Johnson & Johnson later this month. Although this company will initially only supply the US with a few million cans, it is expected to increase production significantly by April. Other vaccines from Novavax and AstraZeneca could also be approved for use in the US this spring, further increasing supply.

Officials are trying to vaccinate as many people as possible to beat more contagious variants of the virus first identified in the UK and South Africa. The variant from Great Britain known as B.1.1.7 is spreading rapidly in the USA. According to a new study, their prevalence doubles roughly every 10 days. The CDC said it could become the dominant form of the virus in the United States by March.

While this variant is of concern because it is more transmissible than previous variants, vaccine developers are more concerned about a variant discovered in South Africa, known as B.1.351, as it appears to interfere with current vaccine effectiveness. Several manufacturers have said they are solving the problem by developing new versions of their vaccines that could serve as booster shots. The Food and Drug Administration has announced that it is working on a plan to allow these new versions of the vaccine to be approved.

AstraZeneca and Oxford University developers of the vaccine announced on Sunday that they are expected to have a modified version of their vaccine available in the fall.

Dr. Scott Gottlieb, former FDA commissioner and member of the Pfizer board of directors, said on CBS’s Face the Nation program on Sunday that it was possible to develop a booster that “bakes in many different variations,” we see. “

“I think there is a reasonable chance that we can be one step ahead of this virus,” he said.

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UK trial experiments with mixing Covid vaccines

Empty vials containing the Pfizer COVID-19 vaccine are seen at a drive-through vaccination facility operated by the Lake County Health Department in Groveland, Florida on January 28, 2021.

Paul Hennessy | NurPhoto | Getty Images

LONDON – A study is being launched in the UK to see if using different Covid-19 vaccines for first and second dose will help make nationwide immunization programs more flexible.

The study, led by Oxford University and conducted by the National Immunization Schedule Evaluation Consortium, will assess the feasibility of using a vaccine for the initial “prime” vaccination other than the subsequent “booster” vaccination.

It is hoped that the study will help policymakers understand whether mixing different Covid vaccines could be a viable way to increase the flexibility of vaccination programs, and whether it could even offer better protection.

“If we show that these vaccines can be used interchangeably on the same schedule, it will greatly increase the flexibility of vaccine delivery and could provide guidance on how protection against new strains of the virus can be enhanced,” said Matthew Snape, chief investigator of the process and associate Professor of Pediatrics and Vaccine at Oxford University said Thursday.

Officially known as the “COVID-19 Heterologous Prime Boost” study but dubbed the “Com-Cov” study, the study will recruit over 800 volunteers aged 50 and over in England to study the four different combinations of Prime and to evaluate booster vaccination.

A first dose of the Oxford AstraZeneca vaccine will be tested, followed by a booster with either the Pfizer BioNTech vaccine or another dose of the Oxford AstraZeneca vaccine. Research will also look at a first dose of the Pfizer BioNTech vaccine, followed by a booster with either the Oxford AstraZeneca vaccine or another dose of the Pfizer BioNTech vaccine. The British government has called the process a “world first”.

These are evaluated in two different dosing schedules: at an interval of four weeks to allow early intermediate reading of the data, and at an interval of 12 weeks. This latter dose interval is the current UK vaccination policy: delaying the second dose means that more people can get their first vaccines sooner with a shortage of vaccinations.

Although the policy has been viewed as controversial, some experts fear that it could make vaccines used in the UK less effective. So far only the candidates from the University of Oxford-AstraZeneca and Pfizer-BioNTech are used. The Moderna shot is due to be added to the vaccine basket later this spring.

However, Oxford University published a study on Wednesday that showed that a 12 week delay between the first and second dose of the AstraZeneca sting increased the vaccine’s effectiveness.

The researchers found that the shot was 76% effective at preventing symptomatic infection for three months after a single dose, and that the effectiveness rate increased to 82.4% if there was an interval of at least 12 weeks before the second dose. When the second dose was given less than six weeks after the first, the rate of effectiveness was 54.9%.

How the Com-Cov study will work

In the latest “Com-Cov” study, researchers will collect blood samples from volunteers from the study and monitor the effects of various dosage regimens on participants’ immune responses, as well as looking for additional side effects for the new vaccine combinations.

The study will last 13 months and was funded by the Vaccines Taskforce, established last April by the UK to coordinate efforts to research and manufacture a coronavirus vaccine, with £ 7 million of government funding (9, USD 5 million).

Professor Snape said the study was “tremendously exciting” before adding that “it will provide information that is critical to the launch of vaccines in the UK and globally”.

The richer countries are making every effort to vaccinate as many people as possible to limit the spread of infections and prevent hospitals from being overrun, which harms the economy.

Britain was hit hard by the pandemic, with cases spiking over the winter, aided by a more virulent variant of the virus that has emerged in south-east England and has now become a dominant strain in the country.

The UK currently has the fourth highest number of cases in the world with over 3.8 million confirmed infections. This comes from a record by Johns Hopkins University and recorded 109,547 deaths.

The UK government was quick to pre-order coronavirus vaccines from various manufacturers early last year and approve the vaccines currently in use. The vaccination program has been widely praised for its agility and range. The aim is to vaccinate 15 million people across the four top priority groups, including health and care workers, the elderly and the over 70s, and those who are considered to be extremely clinically at risk by mid-February.

The latest government data from Wednesday shows that just over 10 million people have received their first dose of vaccine and nearly 500,000 have received a second dose. The UK-made Oxford-AstraZeneca vaccine makes up the bulk of the UK vaccination program.

Professor Jonathan Van-Tam, deputy chief medical officer and senior responsible officer for the study, said the research may even show that alternating vaccines could increase the amount of antibodies needed to fight a possible Covid-19 infection.

“It’s even possible that the combination of vaccines may improve the immune response, resulting in even higher antibody levels that last longer. If this isn’t evaluated in a clinical trial, we just don’t know. This study will give us a better one Provide insight into how We can use vaccines to keep abreast of this dire disease, “he said.

The British vaccination minister Nadhim Zahawi told the BBC on Thursday that the country’s vaccination program will continue as usual for the time being: “At the moment we are not going to change anything,” Zahawi told the “Today” program.

“If you got a Pfizer BioNTech vaccine for your first dose, you got a Pfizer BioNTech vaccine for your second. If you had Oxford-AstraZeneca, you got Oxford-AstraZeneca for your second dose.”

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Covid-19 Information: Even in Poorer Neighborhoods, the Rich Are Lining Up for Vaccines

“It looked like Ward 3 was being punished for being more familiar with computers,” said Mary Cheh, a member of the city council who represents the station, who routinely has homes near American University or the Potomac River sold for more than $ 2 million. “I was inundated with emails from people who were just really angry about it.”

The day after the policy change, Ms. Cheh wrote to constituents, quoting the shooting data, and saying that “our fear of getting one right away shouldn’t tarnish the pursuit of fair vaccine distribution.”

“When I sent this message, people were like, ‘Oh, thanks, I understand now,” Ms. Cheh said. Still, she called the city’s new system “a very blunt instrument” and said it was fairer to meet the needs of that Basing the risk of an individual, not that of a whole neighborhood.

70-year-old Adora Iris Lee lives in one of Washington’s most important neighborhoods – Congress Heights, part of Ward 8 in the southern part of the district, which is severely black and has seen the highest number of Covid deaths. She said she was on hold for more than three hours but was given appointments for herself and her mother, who is 93 years old.

“Being able to call at a time that was reserved for us was good for me,” said Ms. Lee. “People who live in Station 3 and people who live in Station 8 have different social realities. We’re not kidding. “

Even so, Mr. Jones of Bread for the City said that even with the new system, hardly any of the people who came to his clinic for admissions were his regular patients. The clinic began reaching out to its regulars and, with the permission of the city, reserved all first doses for them and for clients of other social organizations last week.

“It’s not just about keeping the seats for the people,” said Jones. “Somehow we have to persuade them to use these spots.”

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E.U. Makes a Sudden and Embarrassing U-Activate Vaccines

BRUSSELS – The European Union abruptly reversed its attempt early Saturday to restrict vaccine exports from the bloc to the UK. This is the latest misstep in the weak vaccine roll-out on the continent.

The bloc was heavily criticized by Britain, Ireland and the World Health Organization on Friday when it announced plans to take immediate action under the Brexit deal to prevent Covid-19 vaccines from being shipped across the Irish border into the UK.

The reversal occurred when the European Commission and its President Ursula von der Leyen were already under fire for the comparatively slow introduction of vaccinations in the 27 member states, especially when compared to Great Britain and the United States.

The commission announced the restrictions without consulting member states or the UK, a former member – unusually aggressive behavior not typical of the bloc, Mujtaba Rahman, head of Europe for Eurasia Group, told a political risk adviser.

“There is clearly panic at the highest levels of the Commission and the issue of the Northern Ireland Agreement has been taken up on this larger issue of poor EU vaccination performance,” he said.

The drama was developing as the bloc’s plan to vaccinate 70 percent of its adult population by the summer came to an end. The European Union was already slow in ordering and delivering vaccines and was hit by a devastating blow when AstraZeneca announced it would reduce vaccine shipments due to production problems.

The original EU plan for export controls sparked outrage in both the Republic of Ireland, a member of the European Union, and Northern Ireland, part of the United Kingdom. Both sides undertake not to restore any land border between the two parts of the island of Ireland.

The triggering of the emergency measures in the Brexit deal so soon after the UK left the bloc’s authority in late 2020 seemed to question the sincerity of the European Union to enforce the deal with Ireland – which is one of the biggest sticking points for reaching the deal was deal. Irish Prime Minister Micheal Martin immediately raised the issue with Ms. von der Leyen.

British Prime Minister Boris Johnson spoke to both leaders. And Arlene Foster, Northern Ireland’s first female minister, described the bloc’s move as “an incredible act of hostility”.

Brits who supported Brexit point to the faster adoption of vaccinations in their country to get out of the bloc and its slower collective processes.

Tom Tugendhat, a Conservative MEP in the UK Parliament who initially opposed Brexit but reluctantly voted for the deal, said on Twitter that the signals from the vaccine dispute are cause for concern.

“Whatever you think about Brexit, it is now perfectly clear how we are seen by the EU – we are out,” he said, “and goodwill is thrifty.” He called for policies that “rebuild relationships”.

Ms. von der Leyen and the Commission were quick to back down, insisting that a mistake had been made and that any vaccine export controls would ensure the Brexit deal, which gave assurances that there would be no new border controls between Ireland and Northern Ireland would be “untouched”. This protocol essentially treats Northern Ireland as part of the European Union’s regulatory space.

It was clear, however, that the move to introduce export controls was aimed at preventing vaccine doses made in the European Union from being sent across the open border on the island of Ireland to the UK.

The British took it as an aggressive act. Mr Johnson called Ms. von der Leyen and said he had “expressed serious concern about the potential impact”.

The World Health Organization joined the criticism of EU export controls, saying that such measures could prolong the pandemic. Its general director, Dr. Tedros Adhanom Ghebreyesus said Friday that “vaccine nationalism” could lead to a “lengthy recovery”. Mariangela Simao, deputy director general for drug access, said Saturday’s move was part of a “very worrying trend.”

After talking to Mr Martin and Mr Johnson and the Council of the Ambassador of the European Union in London, Ms. von der Leyen published a tweet after midnight with the words: “We have agreed on the principle that the export of vaccines must not be restricted by companies with whom they fulfill contractual obligations. “

The bloc still intends to put in place the export controls that could prevent vaccines made in the European Union from being sent overseas, but without including Northern Ireland, which definitely sources its vaccines from the UK.

Earlier this week, the Commission and Ms von der Leyen accused the British-Swedish company of breaching its contract. They suggested that AstraZeneca, which works with a vaccine developed at Oxford University, give the UK preferential treatment and even send some vaccines made in the European Union there instead.

AstraZeneca denied the charges, and its chairman, Pascal Soriot, insisted that the contract with the European Union required only “best efforts” to meet delivery schedules.

The UK signed its own contract with the company three months before the European Union, Soriot said, and under that contract UK-made vaccines would have to get there first.

The lawyers disagreed on the language of the EU treaty, which was only partially published.

Ms von der Leyen, who previously left most of the vaccine dispute to her commissioners, said Thursday that the bloc would put in place a temporary export control mechanism to block exports of vaccines made in the European Union – a move clearly on AstraZeneca that also produces in Belgium.

Approval to use the AstraZeneca vaccine in the European Union was only granted on Friday. The company could therefore hardly be held responsible for the existing vaccination deficits resulting from previous decisions by the Commission to order the entire block in bulk, which lowered the price of vaccines but delayed orders and deliveries.

Nor did it contribute to the block unity when first the German government and then French President Emmanuel Macron cast doubts as to whether the AstraZeneca vaccine was effective for people over 65 years of age – contrary to what the European Medicines Agency said when she approved the vaccine for all adults.

For the German magazine Der Spiegel, which is not a fan of Frau von der Leyen, the abuse of the vaccine rollout is their responsibility. “Europe is facing a vaccination disaster,” wrote the magazine, “which could ultimately turn out to be the greatest catastrophe of its entire political career.”

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Health

Pregnant Girls Might Obtain Covid Vaccines Safely, W.H.O. Says

The World Health Organization on Friday changed its guidelines for pregnant women considering a Covid-19 vaccine and abandoned opposition to immunization for most expectant mothers unless they were at high risk.

The change came after an outcry from WHO’s previous stance that the organization “did not recommend vaccinating pregnant women with the vaccines manufactured by Pfizer-BioNTech and Moderna”.

Several experts expressed their disappointment with the WHO’s earlier position on Thursday. The experts found that this was inconsistent with the guidelines of the U.S. Centers for Disease Control and Prevention on the same topic and would confuse pregnant women who are looking for clear advice.

The vaccines manufactured by Pfizer-BioNTech and Moderna have not been tested on pregnant women, but have not shown any harmful effects in animal studies. According to experts, the technology used in the vaccines is generally known to be safe.

The WHO’s new wording reflects this information:

“Based on what we know about this type of vaccine, we have no particular reason to believe that there are any specific risks that would outweigh the benefits of vaccination for pregnant women.” The recommendation is now closely aligned with the position of the CDC.

Experts praised the postponement and welcomed the agreement between the world’s leading public health organizations on this important issue.

“I was very pleased to see that WHO has changed its guidelines for offering the Covid-19 vaccine to pregnant women,” said Dr. Denise Jamieson, an obstetrician at Emory University and a member of the Covid Expert Group at the American College of Obstetrics and Gynecology. The association was among the many women’s health organizations that urged Pfizer and Moderna to speed up vaccine testing in pregnant women.

“The WHO’s more permissive language is an important opportunity for pregnant women to get vaccinated and protect themselves from the serious risks of Covid-19,” said Dr. Jamieson. “This impressively rapid overhaul by WHO is good news for pregnant women and their babies.”

Pregnant women have traditionally been excluded from clinical trials, so there is a lack of scientific data on the safety of drugs and vaccines in women and their unborn children. Vaccines are generally considered safe, and pregnant women have been encouraged to get immunized against influenza and other diseases since the 1960s, even though rigorous clinical studies have not been conducted to test them.

Pfizer will test its vaccine in pregnant women over the next few months, according to a company spokeswoman. And Moderna plans to set up a registry to monitor side effects in women who have been immunized with the vaccine.