In the USA, the third COVID-19 vaccine approved for use: what you need to know about it
On Friday, February 26, a key FDA advisory panel unanimously endorsed Johnson & Johnson's single-dose COVID-19 vaccine for emergency use, an important step paving the way for the expansion of preventive treatment in the United States to next week. Writes about it CNBC.
US health officials are increasingly concerned about new emerging variants of the virus, in particular the B.1.351 strain from South Africa, which has been shown to reduce the effectiveness of vaccines both on the market and those in development.
The head of the Centers for Disease Control and Prevention (CDC), Dr. Rochelle Walensky, warned that the decline in the number of COVID-19 cases reported in the US since early January could rise again due to new strains.
“Over the past few weeks, the number of illnesses and hospitalizations in the United States has decreased since the beginning of January, and the death rate has decreased in the past week,” said Walenski. "But the latest data suggests that this decline could slow, potentially stabilizing at a still very high level."
Scaling up vaccinations could help mitigate the impact of highly infectious options, said CDC epidemiologist Adam McNeill. He added that the US is not close to herd immunity, but vaccination can help "move us closer to filling the herd immunity gap."
The FDA's advisory committee plays a key role in the approval of influenza and other vaccines in the United States, verifying the safety of vaccines for public use. While the FDA is not required to follow the advice of an advisory committee, it often does. In similar requests from Pfizer and Moderna, the FDA authorized the use of these companies' vaccines the day after the committee upheld an emergency authorization.
Following the vote, Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School and a voting committee member, said the J&J vaccine would help “meet current needs,” as states complain about insufficient supplies of Pfizer and Moderna vaccines.
“We need to release this vaccine now,” said Dr. Jay Portnoy, a professor at UMKC School of Medicine and a voting committee member, after the vote. He added: "We are in a hurry" as the various strains pose a threat to the country's progress in the fight against the pandemic.
J&J's single-dose vaccine "makes things easier in many contexts," Dr. Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, told the Journal of the American Medical Association. "I believe the state health departments are paying a lot of attention to these vaccines, more of the ease of use of the J&J vaccine and how it might be better suited for certain populations."
The clearance means the FDA will allow some people to get the vaccine as the agency continues to evaluate the data. This is not the same as full approval, which requires more data and can usually last several months longer. J&J, like Pfizer and Moderna, provided safety data in just two months, but the agency typically takes six months for full approval. The company is asking the FDA to approve the use of the vaccine for people age 18 and older.
J&J submitted its COVID-19 vaccine data to the FDA on February 4. Its protection varied by region, J&J reports, with an overall efficacy of 66%, 72% in the US, 66% in Latin America and 57% in South Africa, where B.1.351 is spreading rapidly. The company said the vaccine prevented 100% of hospitalizations and a large number of deaths.
The FDA said it will allow the use of a COVID-19 vaccine that is safe and at least 50% effective. According to the CDC, getting the flu shot usually reduces the risk of getting it in people by 40-60% compared to those who have not been vaccinated.
FDA officials approved the J&J vaccine and highlighted in reports that the clinical trial results and safety data "are in line with the guidelines outlined in the FDA's Emergency Vaccine Authorization Guidelines for the Prevention of COVID-19."
What you need to know about the new vaccine
How effective is it
In trials in the United States, Johnson & Johnson's vaccine provided complete protection against death from COVID-19 28 days after vaccination. The rate at which it prevented moderate to severe infections was 72% in US studies 28 days after vaccination. In all trials in the US, Latin America and South Africa, the vaccine was 85% effective in preventing serious illness. Mercury News.
The overall effectiveness of Moderna and Pfizer vaccines is higher - about 95%. But comparing the three drugs is difficult due to differences in design and dosage regimens of clinical trials, experts say.
How these drugs work
The J&J vaccine uses a harmless virus called adenovirus to transmit the genetic code. Pfizer and Moderna vaccines are produced using messenger RNA, or mRNA, a technology that transfers some genetic code to cells.
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In all three vaccines, this code acts as a recipe for making a protein called a spike. Our body perceives this spike protein as an invader and triggers the immune system to produce antibodies and T cells.
If the body is later confronted with the true pathogen COVID-19, it will be able to respond faster and more efficiently, as immune cells and antibodies specific to the virus are rapidly produced in the body to prevent disease.
What is the advantage of the J&J approach
This is a simple, single injection. And this is a huge advantage when it comes to vaccinating as many people as possible, especially in rural areas.
“So this is a vaccine that we can get people to see, not ask them to come up with a vaccine,” said Dr. Niraw Shah, director of the Maine Center for Disease Control and Prevention. "It will open up many new opportunities for vaccination."
In addition, it is easier to send and store. Unlike Pfizer and Moderna vaccines, it does not need ultra-cold storage. Instead, J&J can be stored at standard refrigerator temperatures for up to three months. At lower temperatures, it is estimated to remain stable for a very long time: up to two years.
“We will be able to create more mobile units that will truly help deliver vaccine to some of our hard-to-reach populations,” said Dr. Virginia Kane, director of public administration for Marion County in Indiana. "It will give us access to places where we did not have it before."
Can a new vaccine protect against dangerous variant viruses?
There is good news on this front.
Johnson & Johnson's vaccine was tested in the midst of a global pandemic. Its effectiveness was not influenced by the high prevalence of the variant in Brazil. In South Africa, with a different variant of the virus, the vaccine reduced severe or critical COVID-19 by 81,7% 28 days after vaccination. It was 64% effective against milder diseases. In response, the South African government last week switched to J&J vaccine instead of Novavax or AstraZeneca.
Since Pfizer and Moderna's drugs were tested prior to these disturbing new options, it's not entirely clear how well they will work. However, in the laboratory, they showed a reduced ability to neutralize the current dominant strain in South Africa, which worried some researchers.
Is there a plan if it doesn't work against new options
Yes, it can be adjusted or "enhanced". All three drugs are relatively easy to change.
“With the Pfizer and Moderna vaccines, scientists are simply synthesizing a different strand of messenger RNA,” said Angela Rasmussen, a virologist at Georgetown University. - It's the same with viral vector vaccines like J&J. It's a bit tricky though. They are still recombinant vaccine viruses and can be edited fairly easily in the laboratory to cover these variations. ”
One possible scenario is the so-called "heterologous booster vaccination", where patients are assisted by receiving a vaccine other than their initial dose.
“It is possible that people who were originally vaccinated by Johnson & Johnson could be vaccinated with Pfizer or Moderna,” Rasmussen said.
Are there any side effects
All three vaccines have mild side effects, such as pain at the injection site, fatigue, headache, and muscle and joint pain. This does not mean that they are unsafe. Most likely, this indicates that the immune system is starting to work.
Unexpected side effects of J&J drug occurred with the same frequency among the volunteers who received the vaccine and placebo - about 0,5%. Several rare conditions have been found to be more common with vaccinations, such as conditions associated with blood clots or tinnitus / ringing.
According to the FDA report, no specific vaccine safety issues were identified when analyzed for age, race, and comorbid conditions. The report states that headaches, fatigue and muscle aches were among the most common side effects in people who received the vaccine. There were also complaints of nausea, fever and pain at the injection site.
Dr. Makaya Dogu, head of clinical development and medical affairs for J&J's vaccines division, said two people experienced severe allergic reactions shortly after vaccination. One person participated in an ongoing study in South Africa and developed anaphylaxis, a severe and life-threatening allergic reaction.
The FDA report says there have been several cases of Bell's palsy, a condition in which half of the face sags, but these have been "balanced" with the number commonly found in the general population. The FDA has previously said allergies will be tracked among vaccine recipients.
Anaphylaxis has also been observed with Pfizer and Moderna vaccinations.
Does Johnson & Johnson make adhesive plasters?
It's true. The company was founded in the 1890s to sell disinfectants, insect fumigants and soaps for washing dogs. In the 1920s, she invented the irreplaceable adhesive plaster.
But now Johnson & Johnson is focused on bigger issues. She was one of the first to vaccinate her employees during a devastating outbreak of smallpox, created a vaccine against the Ebola virus. In January 2020, the company began a large-scale study of the COVID-19 vaccine.
When people get a new vaccine
Due to manufacturing issues, only about 4 million doses of COVID-19 vaccine will be available to ship as soon as the drug is approved. Of these, about 2 million will be sent to the states; the remaining 2 million will go to pharmacies and community health centers.
On the subject: COVID-19 Vaccine Allergies and Deaths: What We Know About It
That's well below the 12 million doses the company promised by the end of February. And that's a drop in the bucket to protect the roughly 260 million Americans eligible for the vaccine.
The company says it will have delivered enough doses to vaccinate more than 20 million Americans by the end of March. She promises 100 million doses by the end of June.
Globally, Johnson & Johnson plans to produce 2021 billion doses by the end of 1.
In addition, the company has pledged to provide vaccines to lower-income countries.
Johnson & Johnson is aware of the global nature of the pandemic and the need for widespread access to vaccines against COVID-19, the company said.
Iconic American vaccine company
The first key phase of vaccine production is now being carried out at facilities in three regions: Baltimore, the Netherlands and India. The production of an active drug takes about two months due to the time required to grow biological cells and then purify the active vaccine. It takes five to six weeks to make, test, and release a finished drug.
French manufacturer Sanofi will soon be helping the company to speed up the production of the vaccine. In addition, he plans to open eight international sites. This is a great example of global interconnectedness: one shipment of vaccine is likely to visit several countries along the way - from raw medicine to finished ampoule for injection.
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