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J&J’s one-shot Covid vaccine accredited by Europe

J&J's one-shot Covid vaccine approved by Europe

Crystal Jones, 52, head of the Athens City Department of Health, loads syringes of the vaccine on the first day of Johnson and Johnson’s vaccine.

SOPA pictures | LightRocket | Getty Images

The European Medicines Agency on Thursday recommended approval of the one-off coronavirus vaccine developed by Johnson & Johnson, which may add another weapon to the armory used to fight Covid-19.

The vaccine will now be sent to the EU Commission for approval later on Thursday.

The vaccine has the added benefit of only requiring a single dose and can be stored in most standard refrigerators at temperatures of 2 to 8 degrees Celsius (or about 36 to 46 degrees Fahrenheit), making transportation and storage easier and cheaper makes.

Once delivery begins, the shot could add a lot to Europe’s difficult vaccination program and is the fourth to be approved by the EMA. Two-dose vaccines developed by Pfizer-BioNTech, Moderna and AstraZeneca, and Oxford University have also been approved.

While easier to distribute, the vaccine has been found not to be as effective as the Pfizer and Moderna shots in preventing Covid infection. However, the data shows that it offers an adequate level of protection: data from clinical trials from the United States have shown that J & J’s vaccine is 72% effective against moderate to severe Covid (although it has been found to be less effective in studies elsewhere which gives it an overall efficacy of 66% protection) compared to about 95% for the other two vaccines.

The speed at which the EU can introduce the J&J vaccine is not yet clear. The EU has ordered 200 million cans of the shot, with an option for an additional 200 million, Johnson & Johnson said in a statement last October.

However, it was reported on Wednesday that, like other vaccine suppliers in the EU (Pfizer-BioNTech and AstraZeneca), delivery of the J&J vaccine to the block may be slower than expected.

An unnamed EU official told Reuters that Johnson & Johnson had told the EU it was facing supply issues that could complicate plans to deliver 55 million doses of its vaccine to the block in the second quarter of the year. CNBC has contacted J&J for additional comments on the report and has yet to receive a response.

The European Commission, the EU’s executive branch, said on Wednesday that it had not been informed of any delays from J&J.

Another delay in vaccine supply would exacerbate the already lethargic introduction of vaccines in the EU, which has faced issues due to a slower ordering process than the UK and US, slower deliveries, bureaucracy and hesitant vaccines.

In the US, J&J has signed a contract with the US government to supply 100 million cans by the end of June. On Wednesday, the Biden government announced plans to buy an additional 100 million cans. The announcement came as the White House is working to ramp up production of the vaccine after learning earlier this year that the company had fallen behind in production.

Last week, Biden announced that pharmaceutical company Merck would help manufacture J & J’s Covid vaccine. Under the terms of the agreement, Merck will deploy two facilities in the US for J & J’s vaccine. One will make the vaccine and the other will provide “fill-finish” services when the vaccine is put into vials.

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

Correction: This story has been updated to reflect the correct approval process within the EU.

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CDC panel recommends use of J&J’s single-shot Covid vaccine

J&J does not have large inventory of doses, Biden official says

Illustration of the Johnson & Johnson coronavirus vaccine

Given Ruvic | Reuters

An advisory panel to the Centers for Disease Control and Prevention unanimously voted on Sunday to recommend the use of Johnson & Johnson’s one-off Covid-19 vaccine for those ages 18 and older as the federal government prepares to serve millions of doses this week to send .

As soon as CDC director Dr. Rochelle Walensky accepts the recommendation of the Advisory Committee on Immunization Practices, the federal government can begin shipping doses to locations across the country. The ACIP met in an emergency meeting to review the vaccine dates, which took place on Saturday became the third shot to receive emergency clearance from the Food and Drug Administration.

Walensky said Friday that she “would be ready to review the ACIP recommendation” and “be ready to sign”.

“We are very close to having another vaccine in our tool boxes, the Johnson & Johnson Covid-19 Vaccine. Like many of you, I am pleased to hear that another safe and effective vaccine option could be coming as soon as next week “She said Friday. “An additional safe and effective vaccine will help protect more people, faster.”

Dr. Richard Nettles, vice president of medical affairs at J&J, told lawmakers Tuesday that the company was ready to ship nearly 4 million doses once it receives emergency approval. He added that the company expects to have 20 million cans ready by the end of March.

The introduction of the J&J shot could be a boon to the U.S. vaccine supply. While the new vaccine showed signs of being less effective at preventing Covid-19 in clinical trials when compared to Pfizer-BioNTech and Moderna vaccines, the J&J shot was 100% effective at preventing deaths and hospitalizations, caused by Covid-19 in clinical trials.

The level of protection of the J&J vaccine against Covid-19 in studies varied regionally, according to FDA documents released on Wednesday. About a month after inoculation, the shot showed 72% effectiveness in the US, 61% in Latin America and 64% in South Africa, where variant B.1.351 is spreading rapidly.

In particular, the FDA review found the vaccine was significantly less effective in people aged 60 and over who also had comorbidities like diabetes or heart disease. However, the agency found that the data was too sparse for any conclusions to be drawn.

In contrast, in clinical studies, Pfizer’s vaccine has been found to be 95% effective against Covid-19, while Moderna’s vaccine is around 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.

However, federal health officials have indicated that the one-off J&J regime offers unique logistical benefits that could make it ideal for hard-to-reach populations.

J & J’s vaccine “makes it easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

J&J has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine typically has to be stored in ultra-cold freezers, which are between minus 112 and minus 76 degrees Fahrenheit. However, the FDA recently announced that it could be stored in pharmacies for up to two weeks at standard freezing temperatures. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

– CNBC’s Berkeley Lovelace contributed to this report.

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Health

FDA approves J&J’s single-shot Covid vaccine for emergency use

FDA approves J&J's single-shot Covid vaccine for emergency use

The Food and Drug Administration has approved Johnson & Johnson’s Covid-19 vaccine for emergency use. This gives the US a third tool to fight the pandemic as highly contagious variants are gaining a foothold across the country.

With the FDA’s approval for the emergency on Saturday, the federal government’s plan begins to distribute nearly 4 million doses of J & J’s vaccine to states, pharmacies and community health centers across the country next week. Unlike Pfizer and Moderna vaccines, patients with the single dose of J&J do not need to take a second dose and can be stored at refrigerator temperature for months.

J & J’s vaccine “makes it easier to use in many contexts,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases of the CDC, told the Journal of the American Medical Association during a question and answer session Friday. “I suspect that much of the national health consideration given to these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited to some populations.”

Initially, doses would be limited, J&J said. The company expects to drop 20 million doses by the end of March, said Dr. Richard Nettles, vice president of medical affairs in the US, told the House legislature on Tuesday. J&J has signed a contract with the US government to supply 100 million doses of its vaccine by the end of June. US officials say they are working with the company to increase supply as soon as possible.

In the past few weeks, US health officials have urged Americans to get vaccinated as soon as possible. Officials are increasingly concerned about new, emerging variants of the virus, particularly strain B.1.351, which has been shown to decrease the effectiveness of vaccines both in market and in development. On Friday, the head of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, the declines in Covid-19 cases reported in the US since early January could flatten as the variants spread.

J&J submitted its Covid vaccine data to the FDA on February 4th. The vaccine’s level of protection varies from region to region, J&J said, with the shot showing an effectiveness of 66% overall, 72% in the US, 66% in Latin America and 57% in South Africa, where variant B.1.351 is spreading rapidly. However, FDA documents show that the vaccine was 64% effective in South Africa after about a month. The company said the vaccine prevented 100% of hospital stays and deaths.

The Pfizer vaccine was found to be 95% effective against Covid-19, while the Moderna vaccine was around 94% effective. Infectious disease experts pointed out that J & J’s numbers cannot be used as a head-to-head comparison with the other two vaccines because it is a single dose and the company’s study was conducted when more infections, as well as new, more contagious variants occurred.

The FDA has announced that it will approve a Covid-19 vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.

The FDA has approved J & J’s vaccine for people 18 years of age and older. This is not the same as a full approval which requires more data and which can typically take several months longer. J&J, like Pfizer and Moderna, has only submitted safety data for two months, but the agency typically takes six months for full approval. The FDA approved the emergency use of hydroxychloroquine to treat Covid-19 in March but revoked it in June after additional data showed it provided “no indication of benefit” in coronavirus patients.

The FDA was expected to approve J & J’s emergency vaccine.

The agency’s announcement comes after a key panel unanimously endorsed the emergency vaccine on Friday. The FDA’s Advisory Panel on Vaccines and Related Biological Products plays a key role in approving influenza and other vaccines in the United States and verifying that the vaccines are safe for public use. While the FDA does not have to follow the advisory board’s recommendation, it often does.

After the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and voting committee member, said J & J’s vaccine will help “meet the needs of the moment” as states complain that there is insufficient supply Pfizer and Moderna gives vaccinations.

“We have to get this vaccine out now,” said Dr. Jay Portnoy, professor at UMKC School of Medicine and voting committee member, after the vote. He added, “We are in a hurry” as the variants pose a threat to the nation’s progress on the pandemic.

No specific safety concerns were identified with J & J’s vaccine. Headache, fatigue, and muscle aches were some of the most common side effects among people who received the vaccination, according to an FDA report released Wednesday. There have also been reports of nausea, fever and injection site pain, the report said.

Macaya Douoguih, director of clinical development and medical affairs for the vaccines division at J & J, Janssen, told the FDA panel on Friday that two people had severe allergic reactions shortly after receiving the vaccine. One of the people participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.

The company has announced that it will ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that are between minus 112 and minus 76 degrees Fahrenheit. However, the FDA recently allowed the company to store its vaccine for two weeks at temperatures commonly found in pharmaceutical freezers. Moderna vaccine must be shipped at 13 to 5 degrees above zero Fahrenheit.

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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.