CDC panel recommends Pfizer, Moderna vaccines over J&J attributable to uncommon blood clot circumstances

A health care worker holds a dose of the Johnson & Johnson vaccine.

Phill Magakoe | AFP | Getty Images

An advisory board for the Centers for Disease Control and Prevention on Thursday recommended Pfizer and Modern‘s vaccines over Johnson & Johnson‘s shot for adults ages 18 and up after dozens of people found a rare blood clot after the J&J vaccination, all of whom were hospitalized and nine of them died.

The Advisory Committee on Immunization Practices has unanimously decided to recommend Pfizer and Moderna over the Johnson & Johnson vaccine. CDC director Rochelle Walensky has yet to accept the recommendation.

The CDC has confirmed 54 cases of people who develop blood clots and have low blood platelet levels, a new condition known as thrombosis with thrombocytopenia syndrome that mainly affects younger women. All patients were hospitalized, nine people died and 36 were treated in the intensive care unit.

The US has administered more than 17 million J&J doses since the Food and Drug Administration approved the emergency syringe in February.

“TTS case reporting rates after Janssen vaccines are higher in men and women in a wider age range than previous estimates,” said Dr. Keipp Talbot, chairman of the CDC’s vaccines and safety subgroup, the advisory body.

Although the panel’s recommendation was unanimous, some members struggled with the vote. The CDC experts could also have recommended giving up the shot altogether or restricting it to certain age or demographic groups.

Dr. Pablo Sanchez, a professor of pediatrics at Ohio State University, said he was not recommending J&J admission to any of his patients, despite ultimately standing for the panel’s proposal.

“I just can’t recommend a vaccine associated with a disease that can lead to death,” Sanchez told the committee. “I don’t recommend it to any of my patients’ parents.”

Seven of the patients who died were women and two men, with a mean age of 45 years. Most of the deceased had previous health conditions such as obesity, high blood pressure and diabetes. The death reporting rate was 0.57 deaths per million doses administered, according to the CDC.

“In reviewing these cases, we noticed how quickly patient status deteriorates and leads to death,” said Dr. Isaac See of the CDC’s Vaccine Safety Team joined the advisory board.

According to the CDC, patients typically developed symptoms 9 days after vaccination and were hospitalized 5 days after symptoms appeared. The overwhelming majority of patients were women, 37 total, and the mean age was 44. Seventeen men developed TTS.

Johnson & Johnson’s director of global therapeutic vaccines Penny Heaton defended the company’s shot during the meeting, saying it “saves lives here in the US and on every continent around the world”.

“It’s easy to store and transport,” said Heaton. “In many low- and middle-income countries, our vaccine is the primary and sometimes even the only option in the US as its permanent protection may be the preferred choice for people who cannot or do not want to return for multiple vaccinations.”

Heaton said J&J recognizes the incidents of TTS related to the vaccine and that the condition can be fatal, although cases are rare. She said patient safety and wellbeing remain a top priority for J&J, and the company has several studies underway to identify risk factors related to developing TTS.

In April, the Food and Drug Administration and the CDC stopped briefly the use of the Johnson & Johnson single vaccine after six adult women developed blood clots and low platelet counts at the same time.

A week later, the FDA and the CDC did canceled the break on J&J shots after the independent advisory panel said the benefits of the shots outweigh the risks. At the time, the panel did not recommend restricting admissions based on age or gender. It suggested that the FDA put a warning label on for women under 50.

The FDA has advised health care providers not to give a J&J booster to people who have developed TTS in the past after the first injection. The FDA also said the J&J syringe should not be given to people who received the vaccine from AstraZeneca, even though AstraZeneca is not approved for use in the United States

CDC experts said Thursday that people who received J&J booster doses have not seen any cases of TTS, although the number of boosters is relatively small.

“Currently available evidence supports a causal relationship between TTS and the Janssen COVID-19 vaccine,” the FDA said in the factsheet for healthcare providers.

In October, the FDA and CDC approved authorized J&J boosters for all adults at least two months after receiving their first J&J syringe. More than 800,000 people have received J&J boosters, according to CDC data. People who received their primary vaccination with the J&J shot can also be boosted with the Pfizer or Moderna vaccines.

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Panicked sufferers name medical doctors as Covid vaccine hesitancy rises with J&J blood clot concern

More Americans will likely refuse to get one Johnson & JohnsonThe Covid-19 vaccine, according to U.S. health officials, said six women had developed a rare bleeding disorder with one dead and another in critical condition, public health and vaccines experts told CNBC on Tuesday.

The Food and Drug Administration asked the states early Tuesday Temporarily stop with J & J’s single shot Vaccine “out of caution” after six women aged 18 to 48 years of the approximately 6.9 million people who received the shot developed a bleeding disorder known as cerebral venous sinus thrombosis, or CVST.

All women developed the condition that occurs when a blood clot forms in the venous sinuses of the brain that prevents blood from flowing back to the heart within about two weeks of receiving the shot from the brain, health officials told reporters on a phone call .

“People who have recently received the vaccine in the past few weeks should be aware if they are looking for symptoms,” said Dr. Anne Schuchat, the deputy chief director of the Centers for Disease Control and Prevention during a press conference Tuesday. “If you have received the vaccine and have severe headache, stomach pain, leg pain, or shortness of breath, you should contact your doctor and see a doctor.”

Shortly after the FDA issued the warning, more than a dozen states as well as pharmacies took steps to stop the vaccinations with J & J’s vaccine, sometimes replacing scheduled appointments with the Pfizer and Moderna Covid vaccines. Some doctors say they are already taking calls from worried patients.

People were already skeptical about vaccines before the coronavirus emerged as a brand new pathogen from China in December 2019. U.S. health officials’ warning to states may be even more reluctant to take J & J’s shot and the other vaccines, and threatens to block the vaccine Health experts warned CNBC of the recovery from the pandemic affecting more than 31.2 million Americans infected and killed at least 562,718 people in just over a year.

“Unfortunately, this is likely to exacerbate those who are a little hesitant about getting a vaccine,” said Isaac Bogoch, an infectious disease specialist who served on several drug data and safety oversight panels. “Senior public health officials need to continue to be open, honest, transparent, and most importantly, contextualize that this is a low risk.”

According to Dr. Anthony Fauci, President Joe Biden’s chief medical officer, the goal is to vaccinate between 70% and 85% of the US population – or about 232 to 281 million people – to achieve herd immunity and suppress the pandemic.

To date, more than 120 million Americans, or 36% of the total US population, have received at least one dose of a Covid-19 vaccine, according to the CDC. Around 74 million Americans, or 22% of the total US population, are fully vaccinated, according to the CDC. Children under the age of 16 are not yet eligible to shoot in the United States, and some adults are likely to refuse to get a vaccine.

“This throws a wrench into the plans. It will slow down the rollout,” said Dr. Jeffrey Kahn, director of the Berman Institute of Bioethics at Johns Hopkins University. “People will say, ‘I don’t want this, I want one of the others who don’t have this problem,’ even if it’s an extremely rare occurrence.”

Some americans, especially in black, Hispanic, and rural communitieswere already reluctant to get the J&J vaccine, especially because they found it to be worse than Pfizer and Moderna. The highly effective J&J shot, especially against serious illnesses, showed 72% effectiveness in protecting against Covid in the US about a month after inoculation. This is comparable to the effectiveness of the two-dose vaccines from Pfizer and Moderna of about 95%.

Single-dose vaccines like J&J were critical in “getting into communities where a two-dose regimen was impractical or even possible,” Kahn said. US health officials used J & J’s vaccine primarily to reach poorer urban and rural areas where residents could not easily get to a vaccination clinic or did not have reliable internet access.

“These communities are also the hardest hit by Covid,” said Kahn. “Using J&J interrupt … one stroke to do this effectively and quickly.”

Dr. Stephen Schrantz, who was part of the team leading a J&J vaccine study at the University of Chicago Medicine, said he already had patients who didn’t want the J&J vaccine and said the news would give them more evidence give to say, “See, I told you.”

“I suspect that vaccine adoption and uptake will slow down, there will be a move away from the J&J vaccine even if the CDC and FDA conclude that there is no causal link,” he said. “And when the mask comes off, there may be more cases like we have in Michigan that show up elsewhere.”

Dr. Scott Gottlieb, who sits on Pfizer’s board of directors, predicted the move will nonetheless fuel some people’s “reluctance” to get a Covid vaccine.

“Even if there is no causal link, even if it is extremely rare, we will likely see that the entire conversation is now ignited on social media.” he told CNBC in an interview.

Dr. Purvi Parikh, an infectious disease allergy and immunology specialist at NYU Langone Health, described the FDA warning Tuesday as a “double-edged sword” and said it would likely raise concerns for already reluctant Americans. She also said she had already received “panic calls” from her own patients about the J&J vaccine.

“But if anything, I would like to repeat again: This only gives me more confidence in our system because these security checks work. Hopefully it will give some people peace of mind,” she added on “Squawk on the Street”. “” “Again, to look at the bigger picture, the benefits still far outweigh the risks of this vaccination.”

Dr. Archana Chatterjee, pediatric infectious disease specialist and member of the FDA’s Advisory Committee on Vaccines and Related Biological Products, echoed Parikh’s remark. She added that there is nothing “unusual” in the way US health officials are addressing the problem.

“This is a normal procedure that occurs,” she said.

“But of course whenever a serious adverse event is reported about a vaccine that raises public concern,” she added. “If you talk about vaccine trust or vaccine reluctance, could it have an impact? It certainly is possible.”

Dr. Paul Offit, another member of the Advisory Committee on Vaccines and Allied Biological Products, hopes Americans will be “rational” about the problem, adding that cases of blood clots seem extremely rare. He noted that convincing people in hard-to-reach communities could be a challenge.

“It should be reassuring to the people that the officials are still looking [at the vaccine,] even for rare side effects, “he said.

CNBC’s Kevin Stankiewicz contributed to this article.

Germany suspends AstraZeneca vaccine amid blood clot fears

LONDON – Germany, France, Spain, Italy, Ireland and the Netherlands have joined growing list of countries who have suspended the use of Coronavirus Vaccine developed by AstraZeneca and Oxford University for blood clot problems.

The Dutch government said on Sunday that the Oxford-AstraZeneca vaccine would not be used until March 29, while Ireland said earlier in the day it had temporarily suspended the shot as a precautionary measure.

On Monday, the federal government also announced that it would stop using it. The vaccine authority, the Paul Ehrlich Institute, requested further investigations. The Italian Medicines Agency made a similar announcement on Monday afternoon, and French President Emmanuel Macron also said that use of the vaccine would be suspended pending a ruling by the EU regulator. Spanish Health Minister Carolina Darias said Monday the country would stop using the shot for at least two weeks, Reuters reported, and Portugal later suspended the vaccine as well.

The World Health Organization tried to downplay the ongoing safety concerns and stated last week that there was no link between the shot and an increased risk of developing blood clots. The United Nations Health Department has urged nations to continue using the Oxford-AstraZeneca vaccine.

Even so, some European countries have already stopped the use of the Oxford AstraZeneca vaccine. It added to the region’s worries sick vaccination campaign at a time when the German health department warned that a third wave of coronavirus infections has already started.

Thailand has also stopped the planned use of the vaccine.

The move to discontinue use by Dutch and Irish officials came shortly after the Norwegian Medicines Agency said Three health workers were reported to have been treated for bleeding, blood clots and low platelet counts in the hospital after receiving the Oxford AstraZeneca vaccine. Norway has suspended its vaccination program against Oxford-AstraZeneca.

Geir Bukholm, director of the Infection Control and Environmental Health Department at the Norwegian Public Health Institute, said the Norwegian Medicines Agency will “follow up on these suspected side effects and take the necessary action in this serious situation”.

The picture taken on November 27, 2020 shows “Nikki” Anniken Hars treating a Covid-19 patient in the intensive care unit of Oslo University Hospital Rikshospitalet in Oslo, Norway.

JIL YNGLAND | AFP | Getty Images

The European Medicines Agency, the European Medicines Agency, said there was no evidence that Oxford-AstraZeneca’s vaccine caused blood clots and believed that the vaccine’s benefits “continue to outweigh the risks”.

The EMA admitted that some European countries had stopped using the Oxford-AstraZeneca shot, but said vaccinations may continue to be given while a clot investigation is ongoing.

Irish Prime Minister Micheal Martin told CNBC on Monday that he anticipated a temporary hiatus and that the country wanted to catch up with its vaccination program quickly.

“No causal effect or anything like that has been identified yet, but as a precautionary measure, in line with the precautionary principle and with great caution, our clinical advice has been to halt the program while the EMA reviews,” he said. “This is an undesirable pause, but I still think it’s important that we heed the advice we received.”

How did AstraZeneca react?

“A careful review of all available safety data on more than 17 million people vaccinated with the AstraZeneca COVID-19 vaccine in the European Union (EU) and the UK found no evidence of an increased risk of pulmonary embolism, deep vein thrombosis ( DVT) or thrombocytopenia in a specific age group, sex, specific batch or in a specific country “AstraZeneca said in a statement Sunday.

The most common side effects of the Oxford AstraZeneca vaccine, which does not contain the virus and cannot cause Covid, are usually mild or moderate and improve within a few days after vaccination.

A health worker holds a box of the AstraZeneneca vaccine at the Bamrasnaradura Institute for Infectious Diseases in Nonthaburi Province on the outskirts of Bangkok.

Chaiwat subprasome | SOPA pictures | LightRocket via Getty Images

The pharmaceutical company said that 15 events involving deep vein thrombosis and 22 events involving pulmonary embolism were reported among those vaccinated in the EU and the United Kingdom.

“This is much less than expected to occur naturally in a general population of this size, and it is similar to other approved COVID-19 vaccines,” said AstraZeneca.

What do the experts say?

“Covid definitely causes bleeding disorders and each of the vaccines prevents Covid disease, including more severe cases,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

“Therefore, it is highly likely that the vaccine’s benefits will significantly outweigh the risk of clotting disorders, and the vaccine will prevent other consequences of Covid, including deaths from other causes.”

Evans said it was “perfectly reasonable” to conduct studies on vaccines and coagulation disorders, but added, “It seems a step too far to take precautionary measures that would prevent people from receiving vaccines that prevent disease.”

Many high-income countries – such as the UK, France, Australia and Canada – have decided to continue rolling out the Oxford-AstraZeneca vaccine.

“When there is clear evidence of serious or life-threatening side effects that have important consequences,” Adam Finn, professor of pediatrics at Bristol University, said in a statement.

“So far, however, this has not been the case, and it is highly undesirable to disrupt a complex and urgent program every time people, after receiving a vaccine, develop illnesses that are random and not causal. In situations like this, it is not easy to Making the right call, but a steady hand on the tiller is probably what is needed most, “said Finn.