Tag: Vaccine

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Health

CDC says 28 blood clot instances, three deaths could also be linked to J&J Covid vaccine

CDC says 28 blood clot cases, 3 deaths may be linked to J&J Covid vaccine

The Johnson & Johnson Janssen vaccine

Stephen Zenner | LightRocket | Getty Images

CDC scientists say their investigation into a rare blood clotting problem related to the Johnson & Johnson Covid-19 vaccine identified 28 people who may have developed life-threatening blockages – three of whom have died.

The Food and Drug Administration and Centers for Disease Control and Prevention urged states on April 13 to temporarily cease use of J & J’s vaccine “out of caution” while examining six women ages 18 to 48 who developed cerebral venous sinus thrombosis, or CVST combined with low platelets within about two weeks of receiving the shot.

They recommended resuming use of the shot 10 days later after the CDC found the benefits of the vaccinations outweighed their risks.

CVST is a form of thrombosis with thrombocytopenia, or TTS, which are blood clots with a low platelet count that make patients at risk of stroke. Platelets actually help the blood to clot.

CDC official Dr. Tom Shimabukuro said Wednesday that four of the 28 people with TTS were hospitalized on May 7, one of whom was in intensive care, and two were being discharged to a post-acute care facility. The remaining 19 patients have all been discharged, he said during a presentation to the CDC Advisory Committee on Immunization Practices. The panel voted earlier in the day to recommend the Pfizer BioNTech vaccine for 12 to 15 year olds.

The mean age of the patients with TTS was 40 years and ranged from 18 to 59 years. Women aged 30 to 39 were the greatest risk group. All patients received the J&J shot before the April 13 break. Of the 28 TTS cases, 19 involved the brain, with 10 of those patients suffering from cerebral haemorrhage, Shimabukuro said.

The other clots formed in the lower extremities, pulmonary arteries, or other areas of the body.

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Health

C.D.C Confirms Extra Instances of Uncommon Blood Clot Dysfunction Linked to J.&J. Vaccine

C.D.C Confirms More Cases of Rare Blood Clot Disorder Linked to J.&J. Vaccine

Federal health officials have now confirmed 28 cases, including six in men, of a rare bleeding disorder in adults who have received the Johnson & Johnson Covid-19 vaccine.

Dr. Tom Shimabukuro, deputy director of the vaccination safety bureau at the Centers for Disease Control and Prevention, presented the new cases on Wednesday at a CDC advisory board meeting

The number is an increase from the 15 confirmed cases that were all women reported at the meeting last month.

Although officials have now identified a handful of cases in men, women – particularly between the ages of 30 and 49 – appear to be at increased risk. “The trend is that women in all age groups have higher reporting rates than men,” said Dr. Shimabukuro at the meeting.

Patients with the rare but serious disorder develop blood clots, often in the brain, as well as low levels of platelets, components of the blood that promote clotting. The disorder is a “rare, clinically serious, and potentially life-threatening condition,” said Dr. Shimabukuro.

Last month, after reports first emerged that six women who had received the vaccine had developed the disorder, federal health officials recommended discontinuing use of the vaccine during the investigation. They lifted the suspension 10 days later and warned the vaccine label of possible risks that suggest that there is a “plausible” link between the vaccine and the disease.

22 of the confirmed cases so far involved women and six men. All were adults between the ages of 18 and 59 who received the vaccine before the national break. (Another case was also recorded in a 25-year-old male who participated in the clinical trial.)

Three people have died and four remain in the hospital, including one in intensive care. No new deaths have been documented since last month’s meeting, said Dr. Shimabukuro.

The overall risk remains extremely low. More than 9 million doses of the Johnson & Johnson vaccine have now been administered in the United States.

There were 12.4 cases per million doses in women between 30 and 39 years of age and 9.4 cases per million doses in women between 40 and 49 years of age, the two demographics that appear to be at greatest risk. There were fewer than 3 cases per million doses in older women and men of all ages.

Of the 28 confirmed cases, 12 people who developed the disorder had obesity, 7 had high blood pressure, 3 had diabetes, and 3 were taking estrogen, although it is not yet clear whether any of these factors could significantly increase the risk of the disorder.

Officials will continue to look for cases of the coagulation disorder in vaccinated people, said Dr. Shimabukuro.

There were no confirmed cases of coagulation disorder after the Pfizer BioNTech or Moderna vaccines, which use a different technology, said Dr. Shimabukuro.

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Health

C.D.C. Advisers Endorse Pfizer Vaccine for Youngsters Ages 12 to 15

C.D.C. Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15

The federal government took one final step on Wednesday to bring Pfizer BioNTech coronavirus vaccine to teenagers in the United States, remove an obstacle to school reopening, and cheer millions of families tired of pandemic restrictions are.

An advisory committee of the Centers for Disease Control and Prevention voted The CDC director, Dr. Rochelle Walensky is expected to review the recommendations and approve them later on Wednesday.

“Getting Covid-19 vaccines approved for children ages 12-15 is an important step in removing barriers to vaccinating children of all ages,” said Dr. Yvonne Maldonado, who represents the American Academy of Pediatrics on the Federal Advisory Committee on Immunization Practices.

Many parents eagerly await the availability of vaccines for children, at least in part to expedite their return to school. About a third of eighth graders, usually 13 or 14 years old, still study completely remotely.

In some states, such as Maine, vaccination of teenagers has already started. Others plan to offer the vaccine as early as Thursday. There are nearly 17 million 12 to 15 year olds in the United States, which is 5.3 percent of the population.

Almost every state now has a flood of vaccine doses that could be quickly distributed to teenagers. The dose used to immunize adults is safe and effective for these adolescents too, as clinical studies have shown.

“Sometimes we lose the importance of children and adolescents in the midst of a pandemic – especially older adults are so much in focus,” said Dr. Grace Lee, Committee member and Professor of Pediatrics at Stanford University.

While the risk of serious illness in children is low compared to adults, the coronavirus has infected more than 1.5 million children and sent more than 13,000 to hospitals, according to the CDC, more than were hospitalized for flu in an average year

“It is currently one of the top ten causes of child death since the pandemic began,” noted Dr. Maldonado.

Young children are believed to be less likely to spread the virus than adults, but their ability to transmit it increases with age. Teenagers, especially in high school, can spread the virus just as easily as adults. Children aged 12-17 make up an increasing proportion of Covid cases in the country.

Vaccinating children should increase immunity levels in the US population and help reduce the number of cases.

“Any person with Covid-19 is giving the virus an opportunity to spread, further mutate and further expose our communities,” said Dr. Bill Gruber, Senior Vice President at Pfizer. “The decisions of the health authorities this week bring us one step closer to protecting young people and achieving herd protection.”

Pfizer announced in March that the vaccine appears to be at least as effective in 12-15 year olds as it is in older teenagers and adults. Apart from a slight increase in the frequency of fever, the shots also appeared to have comparable, mostly negligible side effects.

The company plans to monitor study participants for two years after the second dose to assess the long-term safety and effectiveness of the vaccine.

Updated

May 12, 2021, 4:58 p.m. ET

The Food and Drug Administration reviewed the clinical data and on Monday approved the Pfizer vaccine for use in these children. This allowed parents and children to wait weeks for a faster return to normal.

“While it is true that children are generally spared serious illnesses, the fact that they could not be vaccinated has created significant disruptions in their lives that have real developmental ramifications,” said Dr. Amesh Adalja, a senior scientist at the Johns Hopkins Center for Health Security. “By vaccinating this age cohort, these children can get back to their normal lives.”

In a speech at the White House on Wednesday, President Biden pointed out the benefits of the Covid vaccine for children 12 and older and said it was “safe, effective, easy, quick and free”.

“Starting tomorrow, more than 15,000 pharmacies will be ready to vaccinate this age group,” said Biden, adding that pharmacies would make it easier for teenagers to get the first shot in one location and a second shot in another location if needed.

Some experts have raised ethical concerns about vaccinating children who are at low risk for the virus, although healthcare workers and older adults remain at risk in many countries.

“If just thinking as a parent, if I had teenagers, I would probably love to vaccinate my children,” said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security.

Class disturbed

Updated May 5, 2021

The latest on how the pandemic is changing education.

But she added, “I am very concerned about a situation where the few countries in the world that had enough vaccines to protect their adults continue to hoard those vaccines for use in low-risk children.”

School reopenings have spiked across the country as parents, teachers, unions and school authorities worried about outbreaks. Research shows that children are largely spared serious illnesses and are not significant drivers of the spread of the coronavirus, as is the case with influenza.

“This misperception of risk will clearly divert vaccination priorities from the optimal strategic use of vaccines worldwide,” said Drs Adaliah.

The committee also recommended giving the Covid-19 vaccine along with other major vaccines that teenagers may have missed during the year. The agency had recommended waiting two weeks before and after immunization against Covid-19 before receiving other vaccines.

Parents’ reluctance can be the main hurdle. According to a recent survey by the Kaiser Family Foundation, more than 40 percent of parents of teenagers said that they would not vaccinate their children or would only vaccinate them if required by a school.

Some of these parents might change their minds as other children are safe to receive vaccines and resume personal schooling or return to team sports such as soccer and basketball that involve close contact, the researchers suggested.

Others can wait to meet school requirements. Public schools in all 50 states require certain vaccines, but officials may not be able to enforce compliance until the Pfizer BioNTech vaccine has received full FDA approval.

The vaccine now has an emergency approval. Pfizer has applied for full approval from the FDA, but this process is expected to take several months. Even after approval, students can opt out based on medical reasons or religious beliefs.

State and local leaders must make special efforts to reach children in low-income families or in color communities. Black and Hispanic adults have one of the lowest vaccination rates: by May 3, only 25 percent of blacks and 27 percent of Hispanics had been vaccinated, compared with 39 percent of whites.

In order to make the vaccine available to these communities, transport and storage of the cans must be facilitated. The Pfizer BioNTech vaccine can only be stored in standard refrigerators for five days. The companies plan to ship smaller packs for use in doctor’s offices and are developing a formulation that can be refrigerated for up to 10 weeks.

Pfizer and BioNTech plan to file applications for approval of the vaccine in children ages 2-11 in September.

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Health

Why Haven’t You Scheduled Your Covid Vaccine?

Why Haven’t You Scheduled Your Covid Vaccine?

The rate at which people schedule appointments for their Covid-19 recordings is decreasing across the country. Are you one of the people who didn’t get the vaccine?

The Well Desk wants to hear from readers who are hesitant to get the shot – or have questions on behalf of someone who has concerns. What would you like more information about? Do you have any new questions about adolescents and vaccinations? Are you afraid of side effects or have you read conflicting information from different sources? Tell us what you want to know and we will find the answers.

How to submit a question: You can use the form below to send us your questions.

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Politics

Uber, Lyft Will Give Free Rides to Vaccine Websites, Biden Says

Uber, Lyft Will Give Free Rides to Vaccine Sites, Biden Says

President Biden said Tuesday that Uber and Lyft, two of the largest ridesharing in the country, would be offering free rides to vaccination sites starting May 24. This agreement is designed to help him achieve his goal of fully vaccinating 160 million adults by July 4th.

Mr Biden said the ride-sharing initiative would last until then.

In a meeting with a group of six governors from states such as Ohio, Utah, and Maine, he also outlined other initiatives, including setting up vaccination sites at community colleges and another to send FEMA officials across the country to encourage residents to get a shot. The announcement marked an aggressive new phase in the government’s efforts to address vaccine hesitation and expand access.

“We’ll be able to take a serious step towards normalcy by Independence Day,” said Biden, referring to a benchmark he set in March. “And there is still a lot to be done to get there. But I think we can get there. “

Although at least 152 million people in the United States had received at least one vaccine by Monday, according to the Centers for Disease Control, the rate of vaccination has slowed in recent weeks.

Experts say they expected a slowdown, but vaccine reluctance – in part due to an 11-day hiatus in administering the Johnson & Johnson single-dose vaccine – will remain a significant barrier. Only a small percentage of Americans who haven’t been vaccinated say they definitely will, according to recent polls.

Some governors, including West Virginia’s Jim Justice, have begun experimenting with incentives that could sway hesitant or disinterested Americans, though officials are still trying to work out the details of the program. In New York, officials are offering free train and subway tickets with vaccinations.

The governors, who met the president virtually on Tuesday, had their own ideas. Maine Governor Janet Mills announced to Mr. Biden that the state will be offering LL Bean coupons, free fishing and hunting licenses, and tickets to local sporting events as incentives.

“We call this ‘your shot to get outside,'” Ms. Mills said. “Oh, it’s cheesy, I know, but we do know that during the pandemic, the people of Maine took refuge in relief and Mother Nature.”

Mr. Biden seemed amused by the idea and replied, “I suspect this will probably work.”

Ohio Governor Mike DeWine said the Ohio National Guard has set up small vaccination stations in nursing homes across the state. Utah Governor Spencer Cox said pop-up clinics were popping up in churches and health officials were working with clergy to deliver information about the vaccines to parishioners.

Mr. Cox also commended the Food and Drug Administration’s move to approve the Pfizer BioNTech vaccine for children ages 12-15: “Mr. President, we’re really good at having kids here, so we’re excited to have this opportunity, ”he said.

In New York, officials are looking even further afield for potential buyers for their allocation of cans. Governor Andrew M. Cuomo said Monday that the state was waiving residency requirements for vaccination in New York City, meaning tourists from around the country and around the world could come and get vaccinated for free.

The move was first suggested by Mayor Bill de Blasio as a means of increasing tourism, and a vaccine pop-up clinic in Times Square is already serving tourists. More locations in places popular with tourists are expected to follow.

“We had historic tourism levels before the pandemic, up to 67 million tourists in a single year,” said de Blasio on Tuesday. “We want this to come back and I think it’s just a smart thing to roll out the red carpet, welcome people back and say if you need to be vaccinated we want to help you.”

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Health

FDA Authorizes Pfizer-BioNTech Vaccine for Kids 12 to 15

FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15

Vaccinating children is vital to boost population immunity and contain the spread of the coronavirus. Although children spread the virus less efficiently than adults, they make up about 23 percent of the population.

Experts have said the country is unlikely to reach “herd immunity” – the point where virus transmission essentially comes to a halt – but vaccinating children will be important to get as close as possible .

14-year-old Ty Dropic, one of the study participants, urged others his age to get vaccinated so they can build widespread immunity and protect themselves. He had no side effects, which led him to suspect that he was on the placebo. If this turns out to be the case, he plans to be vaccinated as soon as possible.

“I know it can be scary, but it really isn’t as bad as it seems,” he said. “If you get Covid it will be a lot worse than being stuck with a needle for two seconds.”

Ty’s three siblings, ages 8, 10, and 16, are also participating in vaccination trials for their age groups. Your mother, Dr. Amanda Dropic, a pediatrician in northern Kentucky, said most of the parents in her practice were eager to get their children vaccinated to help them regain some semblance of normalcy.

“The anxiety and depression that we see in children, the social delays, have been enormous,” she said.

Dr. Dropic said her children understood the risks and were willing to volunteer because they saw it as a civic duty. Every drug available today came about because “someone was ready to go first,” she added.

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Health

‘It’s a giant deal’ for America’s push to reopen, says NIH Director on Pfizer vaccine approval for adolescents

Pfizer and BioNTech begin the process of seeking full U.S. approval for their Covid vaccine

The director of the National Institutes of Health, Dr. Francis Collins, called the Food and Drug Administration approval for emergency use of Pfizer and BioNTech’s Covid vaccine for children ages 12-15 as “a big deal” in America’s drive to reopen.

“This is exciting news,” said Collins. “We know that since this pandemic started, one and a half million teenagers have been infected with Covid-19, and not all have been as good as most. And some of them have ended up where they have been with this long Covid We are not doing any better , even weeks or months after the illness, so we really want to protect young people. “

The Centers for Disease Control and Prevention’s Vaccine Advisory Board has scheduled a meeting on Wednesday to review recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

More than 44% of all adults in the US are fully vaccinated, and according to the CDC, around 58% have now received at least one dose of the Covid vaccine. The White House aims to increase that number to 70% by July 4th.

Collins told CNBC’s “The News with Shepard Smith” that the US is “on a pretty good path” and that the nation should be able to see CDC regulations to relax indoor masks.

“It’s just about finding the right way to balance the desire not to create another wave. This is the last thing we need right now with the fact that people are really fed up with masks to wear, “said Collins.

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Health

Pope Francis backs Biden name to waive Covid vaccine patents

Pope Francis backs Biden call to waive Covid vaccine patents

Pope Francis, wearing a face mask, attends an interfaith prayer service for peace with other religious representatives at the Basilica of Santa Maria in Aracoeli, a church on the Capitoline Hill of Rome in Rome, Italy, on October 20, 2020.

Guglielmo Mangiapane | Reuters

Pope Francis advocated a waiver of intellectual property rights for coronavirus vaccines on Saturday, reiterating the U.S. government’s comments earlier this week.

World Trade Organization leaders recently called on member states to reach an agreement on possible vaccine patent waivers in hopes of removing barriers to increased vaccine production in developing countries.

President Joe Biden’s team approved the idea on Wednesday. Sales representative Katherine Tai said in a statement that she “supports the lifting of this protection for COVID-19 vaccines.”

At a global fundraiser on Saturday, Pope Francis said the world was infected with the “virus of individualism”.

“A variant of this virus is closed nationalism, which prevents vaccines from internationalism, for example,” he said in comments translated by Reuters.

“Another variant is when we put the laws of the market or the intellectual market or intellectual property above the laws of love and the health of mankind,” added the Pope.

Vaccine makers, whose share prices were affected by the comments earlier this week, have spoken out against the idea. Albert Bourla, CEO of Pfizer, warned on Friday of unleashing a global race for raw materials that threatens the safe and efficient manufacture of vaccines.

Germany and Chancellor Angela Merkel have also spoken out against the waiver, with the country’s BioNTech being a key partner for Pfizer in developing its vaccine. Germans and other European officials argue that making and distributing vaccines faster is critical to ending the pandemic.

“The limiting factor in the manufacture of vaccines is the production capacity and high quality standards, not the patents,” a Merkel spokeswoman said in a statement.

PhRMA, a pharmaceutical industry advocacy group, has called the waiver proposal “an unprecedented move that will undermine our global response to the pandemic and put safety at risk”.

To date, there have been nearly 157 million coronavirus infections and over 3.2 million deaths worldwide, according to data from Johns Hopkins University.

—CNBC’s Rich Mendez and Kevin Breuninger contributed to this article.

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World News

W.H.O. approves China’s Sinopharm vaccine for emergency use.

W.H.O. approves China’s Sinopharm vaccine for emergency use.

The World Health Organization approved China’s emergency Covid-19 vaccine from Sinopharm on Friday, making it easier for poorer nations to get another much-needed shot to end the pandemic.

The approval enables Sinopharm vaccine to be included in Covax, the World Health Organization’s global initiative to promote the equitable distribution of vaccines around the world.

The need is urgent.

Rich countries hoard cans. India, a major vaccine maker, has stopped exporting to deal with the deepening coronavirus crisis. Questions about the safety of extremely rare side effects led some countries to briefly discontinue the use of AstraZeneca and Johnson & Johnson or to change their guidelines for use.

Reliable access to vaccines could continue to improve next week if WHO considers another Chinese shot from the Sinovac company.

Andrea Taylor, who analyzes global data on vaccines at the Duke Global Health Institute, described the possible inclusion of two Chinese vaccines in the Covax program as a “game changer”.

“The current situation is so desperate for low- and lower-middle-income countries that it is worth mobilizing all the doses we can get out of it,” said Ms. Taylor. “Possibly having two options from China could really change the landscape of the possible in the next few months.”

But the fanfare can be short-lived. While China has claimed it could produce up to 5 billion cans by the end of this year, Chinese officials say they are struggling to make enough cans for their own people and are warning a pandemic-weary world to keep expectations in check .

“This should be the golden time for China to practice vaccine diplomacy. The problem is also that China itself is facing a shortage, ”said Yanzhong Huang, Senior Fellow on Global Health at the Council on Foreign Relations. “In terms of global access to vaccines, I don’t expect the situation to improve significantly in the next two to three months.”

Still, the approval marks a high point in vaccine diplomacy efforts and an opportunity to fill the void that Western nations and drug companies have left in low and middle income countries. Sinopharm is the first Chinese shot to be classified as safe and effective by the WHO, and its approval could allay concerns about the lack of transparency by Chinese vaccine companies.

Regulators from China and other countries have approved the Sinopharm vaccine in the past few months, although the company has not released data on phase 3 clinical trials that scientists can independently evaluate.

The WHO had access to this data prior to the announcement, but there is limited data on how well the vaccine will work against the many coronavirus variants that are found around the world.

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Health

WHO chief urges world to observe U.S., waive Covid vaccine patent protections

WHO chief urges world to follow U.S., waive Covid vaccine patent protections

World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus attends a press conference organized by the United Nations Union of Geneva Correspondents Association (ACANU) during the COVID-19 outbreak on July 3, 2020 at WHO headquarters in Geneva, Switzerland has been.

Fabrice Coffrini | Pool | Reuters

The Director General of the World Health Organization, Tedros Adhanom Ghebreyesus, on Friday called on other countries, in particular the Group of the Seven Industrialized Nations, to follow the example of the US and support a request by the World Trade Organization to temporarily waive patent protection for Covid-19 vaccines .

“The US announcement on Wednesday to support a temporary waiver of intellectual property protection for Covid-19 vaccines is an important declaration of solidarity and support for vaccine justice,” Tedros said at a press conference. “I know that this is not easy politically, so I really appreciate the US leadership and we urge other countries to follow suit.”

The USA, which is strongly committed to the enforcement of intellectual property rights around the world, has previously spoken out against the waiver of patent protection for Covid vaccines.

President Joe Biden personally made the decision to change the US stance, White House deputy press secretary Karine Jean-Pierre told reporters aboard Air Force One on Thursday. As a presidential candidate, Biden had supported the abandonment of the intellectual property of Covid vaccines.

The Pharmaceutical Research and Manufacturers of America, whose members include vaccine manufacturers AstraZeneca, Pfizer, and Johnson & Johnson, firmly oppose the Biden government’s decision.

WHO chief Tedros on Friday also called on the G7 industrialized nations – Canada, France, Germany, Italy, Japan and Great Britain, as well as the USA – to do more to facilitate the equitable distribution of Covid vaccines worldwide.

“For G-7, vaccines and vaccine equity are now the most important and immediate support we need,” said Tedros. “I think everyone knows what we should do to increase production capacity and then increase vaccination rates in all countries.”

According to the WHO chief, more than 80% of the more than 1 billion Covid vaccine doses distributed worldwide went to high-income countries, while low-income countries received 0.3%.

“That kind of gap is unacceptable,” said Tedros. “It is not only unacceptable on moral grounds, but also because we will not defeat the virus in a divided world.”

“It is in the interests of every country in this world to exchange vaccines and to contribute in every possible way to ensure the justice of the vaccines,” said the WHO chief. “Vaccine equity is not a charity. Vaccine equity is in everyone’s interest.”

The demand for the revocation of patent protection proposed by India and South Africa last October is facing an uphill battle at the WTO, which takes decisions by consensus among its 164 member states.

Germany, Europe’s largest economy, has spoken out against the attempt to temporarily forego vaccination patents. BioNTech, which developed a Covid vaccine in collaboration with Pfizer, is based in Germany.

“The US proposal to lift patent protection for Covid-19 vaccines has a significant impact on vaccine production as a whole,” said a spokesman for the federal government on Thursday. “The limiting factor in vaccine production is the production capacity and high quality standards, not the patents.”

After the US reversal, the governments of Canada, Italy, Japan and Great Britain did not take any clear public positions for or against the renunciation of the protection of intellectual property. French President Emmanuel Macron supported the US position.

The President of the European Commission, Ursula von der Leyen, who heads the executive body of the European Union, did not accept the waiver plan and declared in a speech that she was “ready to discuss proposals for effective and pragmatic management of the crisis”.

Russia, which developed the Sputnik vaccine, has expressed support for the move and China is open to further discussion. The WHO announced on Friday that it has approved the emergency vaccine developed by China’s Sinopharm.

According to The Associated Press, which quoted a Geneva-based trade official, around 80 WTO countries, mostly developing countries, have expressed support for the proposal.

“It’s also important to remember that abandoning intellectual property must go hand-in-hand with a transfer of technology and expertise for these elusive vaccines,” said Tedros.