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Pausing J&J Covid vaccine may have far reaching results: Dr. Kavita Patel

U.S. states face steep decline in J&J vaccine

Dr. Kavita Patel told CNBC on Tuesday that she believes the Food and Drug Administration’s recommendation that states stop using Johnson & Johnson’s single-shot Covid vaccine is likely to have a lasting impact on the country’s efforts to fight the pandemic.

“This is a devastating blow to this J&J vaccination effort in the US,” said Patel, a family doctor in Washington, DC, in an interview on Squawk Box. She also worked on health initiatives in the Obama administration while serving as director of policy for the Bureau of Interstate Affairs and Public Engagement.

Patel said the supply of Pfizer and Moderna’s two-shot vaccines will not be able to quickly meet the demand caused by the J&J hiatus. This will delay US vaccination efforts, she added.

The FDA recommendation, released Tuesday, came after six people in the US experienced rare and severe blood clotting problems after receiving the J&J vaccine.

In a tweet, the US regulator said its actions were taken “out of caution”.

All six cases occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the shot.

So far, J&J has said that there is “no clear causal link” between these rare events and the vaccine. The US drug giant also said it was working with regulators.

While she anticipates that Moderna and Pfizer will at some point be able to “fill some of that void,” said Patel, “it will be some time” before these other vaccine manufacturers have additional doses available in the US

A particular challenge in discontinuing the administration of J & J’s vaccine is that it only requires a single shot, while Moderna and Pfizer’s mRNA vaccines require two doses for complete protection of immunity.

“We just can’t replace it for the next week or three,” said Patel, a medical assistant for NBC News and a non-resident of the Brookings Institution. “This will delay our vaccination efforts.”

To compensate for this, the US could consider reducing second-dose administration to recipients of Moderna and Pfizer vaccines, Patel suggested.

The Chief Medical Officer of the White House, Dr. Anthony Fauci, has spoken out against requests earlier in the pandemic.

The second dose of Moderna is supposed to be given four weeks after the first, while Pfizer is three weeks apart.

“You will hear a renewal for calls to delay that second shot so we can get that many first shots in the arms. It’s not an unreasonable thing to think about now,” said Patel.

“If we postpone the second dose of Moderna or Pfizer for a week or two, it might actually help us fill some of that void faster,” she added.

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Covid-19 Vaccine Facet Results: Your Questions Answered

Covid-19 Vaccine Side Effects: Your Questions Answered

Almost three million people in the United States receive the Covid-19 vaccine every day. And each new burst raises new questions about what to expect after vaccination.

Last week I asked readers to send me their questions about vaccinations. Here are some of the answers.

Short-lived side effects such as fatigue, headache, muscle pain, and fever are more common after the second dose of the Pfizer BioNTech and Moderna vaccines, which each require two shots. (The Johnson & Johnson vaccine only requires a single shot.) Patients who experience uncomfortable side effects after the second dose often describe feeling like they have a bad flu and use phrases like “it blew me out” or ” I was useless for two days. “During vaccine studies, patients were advised to take a few days off after the second dose, just in case they had to spend a day or two in bed.

The data collected by v-safe, the app that anyone can use to track side effects after vaccination, also shows an increase in reported side effects after the second dose. For example, about 29 percent of people reported fatigue after the first Pfizer BioNTech shot, but that increased to 50 percent after the second dose. The muscle pain increased from 17 percent after the first shot to 42 percent after the second. While only about 7 percent of people had chills and a fever after the first dose, that number rose to about 26 percent after the second dose.

The New York Times interviewed several dozen of the people who were newly vaccinated in the following days. They reported a wide range of reactions, from no reaction to symptoms such as uncontrolled tremors and “brain fog”. While these experiences are not pleasant, they are a sign that your own immune system is having a strong response to the vaccine.

An analysis of the first 13.7 million Covid-19 vaccine doses given to Americans found that side effects were more common in women. While severe reactions to the Covid vaccine are rare, almost all cases of anaphylaxis or life-threatening allergic reactions have occurred in women.

The finding that women are more likely to report and experience unpleasant side effects from the Covid vaccine is consistent with other vaccines as well. Women and girls after flu vaccinations and vaccines against measles, mumps and rubella (MMR) and hepatitis A and B can produce up to twice as many antibodies. One study found that in nearly three decades, women accounted for 80 percent of all anaphylactic diseases in adults.

Although women report side effects more often than men, the higher rate of side effects in women also has a biological explanation. Estrogen can stimulate an immune response, while testosterone can weaken it. In addition, there are many immune-related genes on the X chromosome, of which women have two copies and men only one. These differences may explain why far more women than men suffer from autoimmune diseases, which occur when a robust immune response attacks healthy tissues in the body. You can read more about women and vaccine side effects here.

Side effects get all the attention, but when you look at data from vaccine clinical trials and the real world, you will find that many people don’t experience side effects beyond an aching arm. In the Pfizer vaccine studies, about one in four patients reported no side effects. In the Moderna studies, 57 percent of patients (64 or younger) reported side effects after the first dose – these jumped to 82 percent after the second dose, meaning that almost one in five patients reported no reaction after the second shot.

A lack of side effects doesn’t mean the vaccine isn’t working, said Dr. Paul Offit, professor at the University of Pennsylvania and a member of the Food and Drug Administration’s Vaccine Advisory Board. Dr. Offit found that a significant number of people reported no side effects during the vaccine trials, and yet the studies showed that around 95 percent of people were protected. “That proves you don’t have to have side effects to be protected,” he said.

Nobody really knows why some people have a lot of side effects and others don’t. We know that younger people develop a stronger immune response to vaccines than older people, whose immune systems become weaker as they get older. Women usually have stronger immune responses than men. But even these differences don’t mean you aren’t protected if you don’t feel a lot after the shot.

Scientists still aren’t sure how effective the vaccines are in people whose immune systems may be weakened by certain conditions, such as cancer treatments, HIV infection, or because they are taking immunosuppressive drugs. However, most experts believe that the vaccines still offer these patients some protection against Covid-19.

Updated

April 1, 2021, 11:02 p.m. ET

The bottom line is that although individual immune responses can vary, the data collected so far shows that all three US-approved vaccines – Pfizer-BioNTech, Moderna, and Johnson & Johnson – are effective against serious illness and death from Covid-19 .

You shouldn’t try to prevent discomfort by taking a pain reliever before receiving the shot. The concern is that premedication with a pain reliever like acetaminophen (Tylenol) or ibuprofen (Advil, Motrin), which can prevent side effects like arm pain, as well as fever or headache, could also weaken your body’s immune response.

While it’s possible that taking a pain reliever before your shots may have dampened your body’s immune response, vaccine experts say you shouldn’t worry and shouldn’t try to get another shot. Studies of other vaccines suggest that while premedication can reduce the body’s immune response to a vaccine, your immune system can build strong enough defenses to fight infection. A review of studies involving more than 5,000 children compared antibody levels in children who took pain relievers before and after vaccinations and in children who did not. They found that pain medication had no significant effect on the immune response and that children in both groups produced adequate levels of antibodies after their shots.

The high effectiveness of all Covid vaccines suggests that even if taking Tylenol before the shot weakens your body’s immune response, there is some margin and you are likely still well protected against Covid-19. “You should feel reassured that you have enough immune response to be protected, especially with vaccines that are this good,” said Dr. Offit.

“It’s okay to treat side effects with pain relievers,” said Dr. Offit, but if you don’t really need one, “don’t take it”.

While most experts believe it is safe to take a pain reliever to relieve post-vaccination discomfort, they do not recommend taking it preventively after the shot or if your symptoms are manageable without the drug. The concern about taking an unnecessary pain reliever is that it may weaken some of the effects of the vaccine. (In terms of vaccine, there is no significant difference if you choose acetaminophen or ibuprofen.)

During the Moderna study, about 26 percent of people took acetaminophen to reduce side effects, and the vaccine’s overall effectiveness was still 94 percent.

Research and individual reports suggest that people with a previously diagnosed Covid-19 infection may react more strongly and experience more side effects after their first dose of vaccine than people who have never been infected with the virus. A strong reaction to your first dose of vaccine could also be a sign that you were previously infected, even if you weren’t aware of it.

If you’ve previously tested positive for Covid-19 or had a positive antibody blood test, be prepared for a stronger reaction to your first dose and plan a few days off just in case. Not only will it be more convenient to stay at home and rest in bed, the vaccine side effects may be similar to symptoms of Covid-19, and your staff won’t want to be around you anyway.

Studies suggest that a dose might be appropriate for people with a previously confirmed case of Covid-19, but medical guidelines have not changed so far. If you received the Pfizer-BioNTech or Moderna vaccines, you should plan to receive your second dose, even if you have had Covid-19. Skipping your second dose can cause problems if your employer or airline requests proof of vaccination in the future. If you live in an area where Johnson & Johnson’s single-dose vaccine is available, you can be fully vaccinated after just one dose. Read more about the vaccine response in people with Covid-19 here.

The vaccines appear to be effective against a new variant that originated in the UK and is rapidly dominating the US. However, some variants of the coronavirus, especially one first identified in South Africa and one in Brazil, appear to be better able to evade antibodies in vaccinated individuals.

That sounds worrying, but there is reason to be hopeful. Vaccinated individuals exposed to a more resistant variant still appear to be protected from serious diseases. And scientists have a sufficiently clear understanding of the variants that they are already working on to develop booster shots that target the variants. The variants identified in South Africa and Brazil are not yet widespread in the United States.

People who are vaccinated should continue to wear masks in public and follow public health guidelines, but they shouldn’t live in fear of variations, said Dr. Peter J. Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “If you are vaccinated you should feel pretty sure how protected you are,” said Dr. Hotez. “It is unlikely that you will ever go to a hospital or intensive care unit with Covid-19. In time, you will see a recommendation for a booster. “

I hope these answers will reassure you about your own vaccine experience. For a more complete list of questions and answers, see our dedicated vaccine tool, “Answers to All Your Covid-19 Vaccination Questions”.

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Extra EU international locations halt AstraZeneca shot as EMA opinions uncomfortable side effects

More EU countries halt AstraZeneca shot as EMA reviews side effects

An Army health worker prepares a dose of Covishield, AstraZeneca / Oxford’s Covid-19 coronavirus vaccine from the Indian Serum Institute at an Army hospital in Colombo on January 29, 2021.

Sign S. Kodikara | AFP | Getty Images

LONDON – Two other countries decided on Tuesday to suspend use of the AstraZeneca vaccine in Europe amid blood clot concerns as regulators conducted a new side effects review.

Sweden and Latvia announced Tuesday morning that they are suspending the rollout of the AstraZeneca vaccine developed with Oxford University. Portugal, Luxembourg and Slovenia decided to stop using the shot on Monday evening. Earlier in the day, Germany, France, Italy and Spain also joined the group of nations that stopped using the vaccine.

So far, 13 countries in the European Union have made this decision, while a few others have stopped using individual lots of the AstraZeneca vaccine. Austria first decided last week after the death of a 49-year-old woman who received this vaccine to stop using a certain batch of AstraZeneca shots.

“The benefits still outweigh the risks.”

The European health authority has insisted that “the benefits of the AstraZeneca vaccine in preventing Covid-19, with the associated risk of hospitalization and death, outweigh the risks of side effects”.

In a statement on Monday, the European Medicines Agency said it would “look further into the information” and called an extraordinary meeting on Thursday on the subject. The institution then reiterated its position during a press conference on Tuesday.

“There is currently no evidence that vaccination caused these conditions,” said Emer Cooke, director of the European Medicines Agency. “The benefits still outweigh the risks, but this is a serious problem and requires serious and detailed scientific assessment. We are currently involved in that.”

She added, “We are concerned that this could affect vaccine confidence … but our job is to make sure the products we approve are safe.”

Of course, we need speed, not just for the economy, but above all for the health of our citizens, but at the same time we need security.

Paolo Gentiloni

EU commissioner for the economy

The World Health Organization has urged nations to continue their vaccination campaigns with the AstraZeneca vaccine and Oxford University.

A number of EU countries have spoken out in favor of the shot. In Belgium, Health Minister Frank Vandenbroucke said on Monday that interrupting use was “irresponsible”. While the authorities in the Czech Republic have also announced that they will continue to administer the vaccine.

Outside the EU, Canada, Australia and the UK have also joined forces to support AstraZeneca.

According to the European Center for Disease Prevention and Control, more than 6 million doses of the AstraZeneca shot have been administered in the EU to date.

AstraZeneca announced on Sunday that of the 17 million people vaccinated in the EU and the UK, 15 had deep vein thrombosis events and 22 cases of pulmonary embolism. This is based on data received as of March 8th.

“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,” the company said in a statement.

Concerns about the vaccine could jeopardize the EU’s goal of vaccinating 70% of the adult population by the end of the summer. The AstraZeneca vaccine has proven popular in Europe so far because it is cheaper than its competitors and easier to store. This could then possibly delay the economic recovery in the region.

“Of course we need speed, not only for the economy, but above all for the health of our citizens, but at the same time we need security,” said Paolo Gentiloni of the European Commission at a press conference on Monday.

He added that the precautionary measures were “justified” and that the EMA review should “keep our EU citizens safe”.

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These are the commonest unwanted side effects from J&J’s

These are the most common side effects from J&J's

A Johnson & Johnson logo is seen in this photo image in front of a medical syringe and vial of coronavirus vaccine.

Pavlo Gonchar | SOPA pictures | LightRocket | Getty Images

Headache, fatigue, and muscle aches were some of the most common side effects in people who received Johnson & Johnson’s one-off coronavirus vaccine in clinical trials, according to a report by the U.S. Food and Drug Administration released Wednesday.

In the report, FDA staff endorsed J & J’s one-shot coronavirus vaccine for approval for emergency use. If approved, it will be the third vaccine to be approved in the US after Pfizer-BioNTech and Moderna.

Post-vaccination side effects are common, doctors say, and usually signs that they are helping to protect against the disease. The FDA determined that the clinical trial results and safety data “are in accordance with the recommendations in the FDA guidelines on emergency approval of vaccines to prevent COVID-19.”

The most common, least severe “local” side effect among vaccinated subjects was injection site pain, which was reported by nearly half of vaccine recipients compared with about 17% in the placebo group. Skin redness or erythema and swelling were reported less frequently, the FDA said.

The most common “systemic” side effects, typically less common than local reactions but more serious, were headache and fatigue, according to the report. Almost 40% of people who received the vaccine reported having a headache, and just over 38% reported feeling tired.

More than 33% of people vaccinated said they had muscle pain, around 14% reported nausea, and under 10% had a fever, according to the report. Most of the side effects were reported in younger people ages 18 to 59, according to the FDA, although most age groups reported similar nausea rates.

FDA staff found that most people who received the vaccine were able to shake off the side effects within days of their shot.

While the rate of unexpected side effects was similar between the vaccine and placebo groups, there was a slight imbalance in some responses in the vaccine group compared to those given a placebo. The vaccine group reported 15 cases of “embolic and thrombotic events” or blood clots in 14 recipients compared to 10 in the placebo group.

There were also six cases of tinnitus, a ringing or buzzing in at least one ear, among vaccine recipients compared to none in the placebo group, the FDA found.

However, the agency said current data “is insufficient to establish a causal link between these events and the vaccine”.

The report found a “balanced” number of cases of Bell Paralysis, a condition in which half of your face falls off. The FDA previously announced that the condition would be monitored in recipients of other vaccines and noted that this isn’t necessarily a side effect, but it’s worth looking out for.

The FDA said there have been no reports of anaphylaxis – a serious and life-threatening allergic reaction that rarely occurs after vaccination – immediately after vaccination.

Some cases of anaphylaxis have been reported in people who received either Pfizer’s or Moderna’s shot, although researchers say they occurred in the range of cases reported for the influenza vaccine, according to a report published Friday by the U.S. Centers for the Disease control and prevention stating.

J&J first submitted its Covid vaccine data to the FDA on February 4th. While the vaccine’s level of protection varied by region, the company said the vaccine prevented 100% of hospital admissions and deaths.

– CNBC’s Berkeley Lovelace Jr. contributed to this report.

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Moderna Covid vaccine unwanted effects: Fatigue, complications, muscle ache

Moderna Covid vaccine side effects: Fatigue, headaches, muscle pain

Tony Potts, a 69-year-old retiree who lives in Ormond Beach, will receive his first injection as a participant in a Moderna-sponsored Phase 3 COVID-19 clinical vaccine trial on August 4, 2020 at Accel Research Sites in DeLand, Florida.

Paul Hennessy | NurPhoto | Getty Images

Fatigue, headaches, and muscle aches are the most common side effects of Moderna’s Covid-19 vaccine, along with some rare symptoms such as persistent nausea or vomiting and facial swelling that are likely caused by the gunfire. That is based on new data released Tuesday by Food and Drug Administration.

On the positive side, people over 64, who are also among the most severely affected by the disease, were generally better tolerated than younger people.

Vaccine side effects are common. It’s actually an immune response that indicates the shots are working as intended, doctors say. Many doctors advise the public to prepare for some more severe side effects than usual with the Covid-19 injections than, say, a typical flu shot, and possibly to take a day or two off to recover.

Moderna’s vaccine, which was approved by FDA officials on Tuesday, is more than 94% effective and safe enough to meet agency requirements for an emergency, according to the report. However, the regulator’s analysis found that the vaccine was associated with common and unpleasant, but not necessarily dangerous, side effects.

More than 9 out of 10 participants who received the vaccine felt pain at the injection site, nearly 7 out of 10 felt tired, and about 6 out of 10 had a headache or muscle pain, the FDA said.

More than 44% of people who received the vaccine reported having joint pain and over 43% reported having chills. The FDA found that more serious “serious side effects” occurred in 0.2% to 9.7% of participants, “occurring more often after the second dose than after the first. Like Pfizer’s Covid vaccine that the FDA approved last week, Moderna’s vaccine also requires two shots, separated by a few weeks.

According to the FDA, nearly 15% of vaccine participants had a fever after the first or second dose.

Some side effects were tough to shake, although most were resolved within a week, the FDA said. Less than 6% reported symptoms that lasted for at least a week after the shot, but that were similar to the placebo group. Some of the study participants had a fever that lasted for more than a week. Seven were in the vaccine group and four were given the placebo, the FDA found.

The FDA said there were seven “serious adverse events” in the study, but none of them were fatal. Four were attributed to the vaccine by investigators and Moderna, including persistent nausea and vomiting, facial swelling, and rheumatoid arthritis.

The FDA staff also recommended that people receiving the vaccine be monitored for possible cases of Bell’s palsy. This isn’t necessarily a side effect, but it’s worth looking out for now that four of the 30,000 participants in the study contract this condition, which causes half of your face to fall off.

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Unwanted effects are indicators shot is constructing safety, says ex-FDA chief

Side effects are signs shot is building protection, says ex-FDA chief

Covid-19 vaccine side effects are signs that the shots are helping to protect against the disease, said former FDA chief Dr. Margaret Hamburg on Thursday opposite CNBC.

“The data tell us that this vaccination produces a fairly routine response at the time of administration, but it is noteworthy when you receive the vaccine,” she said on Squawk Box. “You will know when you will receive the vaccine, but that will also show you that it works and that your body is reacting,” added Hamburg, who headed the regulator in the Obama administration from 2009 to 2015.

The Hamburg statements come when the vaccine committee of the Food and Drug Administration meets on Thursday whether Pfizer and German partner BioNTech should vote for the emergency approval of the Covid-19 candidate. The non-binding decision by the panel of experts is a final step before the FDA is expected to approve the vaccine for limited use.

The agency will meet next week at the request of Massachusetts-based Moderna to obtain the same approval. The vaccine is similar to Pfizer’s in that they both take a new approach that uses genetic material to trigger an immune response.

Pfizer’s vaccine was approved by regulators in the UK last week, where the first shots for non-trial participants were given on Tuesday. However, the two allergic reactions reported by UK health workers prompted UK regulators to advise people with a history of “significant” allergic reactions to abstain from the vaccine for the time being.

Coronavirus vaccine development deadlines have been hastened this year by drug makers and governments alike in hopes of finding a solution to the devastating pandemic that killed at least 1,571,890 people worldwide, according to Johns Hopkins University. The US recorded a record 3,124 deaths on Wednesday.

Both Pfizer’s and Moderna’s vaccines were shown to be more than 94% effective in preventing symptomatic Covid-19, according to data from large-scale clinical trials.

Some of the reported side effects are “local swelling, irritation, pain, fatigue, sometimes headache,” said Hamburg. “A percentage of the patients had chills and a slight fever.”

Dr. Moncef Slaoui, who leads the Trump administration’s vaccine development efforts, has defended the safety of Pfizer and Moderna vaccines. He said earlier this month that “significantly noticeable” side effects from the admissions were reported in only 10% to 15% of study participants, which may lasted up to a day and a half.

Both Pfizer’s and Moderna’s vaccines require two doses. Some doctors have tried to raise awareness of the side effects so that vaccine recipients aren’t deterred from getting the second shot.

“We really need to make patients aware that this is not going to be a walk in the park,” said Dr. Sandra Fryhofer of the American Medical Association in November at an advisory panel meeting of the Centers for Disease Control and Prevention. “You will know you had a vaccine. You probably won’t feel wonderful. But you have to come back for that second dose.”