Tag Archives: FDA

Johnson & Johnson Vaccine

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A single-shot coronavirus vaccine from pharmaceutical giant Johnson & Johnson was effective at preventing illness, hospitalizations and deaths in global trial. But its protection against sickness was stronger in the United States and weaker in South Africa, where a worrisome coronavirus variant now dominates.

The results, once granted emergency use authorization by the FDA, would put a third vaccine on the market in the United States. A third vaccine could accelerate the ability to broaden immunity, as variants that challenge the current generation of vaccines spread across the world.

The vaccine trial was primarily designed to measure how well the vaccine prevented illness. It was 66 percent effective overall at preventing moderate and severe disease: it was 72 percent effective at protecting against moderate to severe illness in the United States, but it was 66 percent effective in Latin America and 57 percent effective in South Africa, where concerning variants have taken root.

Company officials emphasized the vaccine was 85 percent effective at preventing severe illness, and there were no cases of COVD-related hospitalization and death in people who received the vaccine. There were five COVID-related deaths in the trial, all in people who received the placebo, not the vaccine.

Johnson & Johnson is expected to apply for emergency use authorization from the Food and Drug Administration late next week. If the review follows the path of two earlier vaccine candidates, the shot could be authorized and available to the public by March.

The J&J vaccine uses a different technology than the two FDA  authorized mRNA vaccines. This vaccine employs ‘a harmless cold virus’ to deliver a gene that carries the blueprint for the spiky protein found on the surface of the coronavirus. The virus infects cells, which then follow the genetic instructions to construct a replica of the coronavirus spike.

In contrast, the Pfizer and Moderna vaccines use a strip of genetic material called messenger RNA to instruct cells to build the spiky protein found on the surface of the coronavirus. In both cases, the immune system learns to recognize the real virus by mustering an immune response to the spike.

References:

  1. https://www.washingtonpost.com/health/2021/01/29/covid-vaccine-johnson-and-johnson
  2. https://www.washingtonpost.com/health/2020/09/23/coronavirus-vaccine-jj-single-shot/?itid=lk_inline_manual_2

mRNA Vaccine Safe and Its Side Effects

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Moderna and Pfizer COVID-19 vaccine trials show that side effects are common in participants and it appears that the more significant symptoms develop following the second dose.

The Pfizer-BioNTech’s mRNA coronavirus vaccine (BNT162b2) is both safe and effective, according to the U.S. Food and Drug Administration (FDA). FDA said results from Pfizer’s large, ongoing study showed the vaccine, which was co-developed with Germany’s BioNTech, demonstrated more than 95% efficacy across people of different ages, races and underlying health conditions, including diabetes and obesity. And partial protection from coronavirus appears to begin 12 days after the first dose, according to Pfizer. Consequently, Pfizer requested and the vaccines are expected to be approved for emergency use authorization (EUA) by the FDA as early as this week.

And this week, a committee of leading U.S. vaccine scientists recommended that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans.

FDA approval of a drug means that the agency will have determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. Approval of the he vaccine will help reduce the risk of disease. The vaccine works with the body’s natural defenses to safely develop protection (immunity) to disease, according to the FDA’s website.

How an mRNA vaccine works

Messenger RNA vaccines, called mRNA for short, is a new kind of vaccine technology that has never before been licensed in the U.S. mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions for how to make a harmless protein that is unique to the virus. The objective of a vaccine is to teach your immune systems how to recognize and fight the virus that causes COVID-19, according to the Centers for Disease Control and Prevention.

Messenger RNA vaccines aren’t like past seasonal influenza vaccines. An mRNA vaccine is essentially just a piece of genetic code that contains instructions for our body. The mRNA tells our cells to make a protein — the same protein that is the spike on top of the actual coronavirus. This is what triggers the immune response in these types of vaccines.

In contrast, past seasonal influenza vaccine puts a weakened or inactivated virus into your body to trigger an immune response, which then produces antibodies. Those antibodies are what ultimately protects you from getting infected if you ever encounter the real virus.

It typically takes a few weeks for the body to build immunity against COVID-19 infection after vaccination. And after vaccination, the process of building immunity can cause symptoms or “side effects”. These symptoms are normal and are a sign that the body is building immunity.

Side effects

Sometimes the vaccine process of teaching your immune system how to react to the virus can cause symptoms. These symptoms are normal and are a sign that the body is building immunity. Moreover, no major safety issues were uncovered and common vaccine-related side effects like fever, fatigue and injection site pain were tolerable, according to the FDA.

The most common vaccine side effects were injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%), acc riding to the report submitted to the FDA.

Severe adverse reactions occurred in 0.0% to 4.6% of participants and appeared were more frequent after the second dose than after the first. The frequency of serious adverse events was low (<0.5%), without meaningful imbalances between study arms.

Although some COVID-19 trial participants reported COVID-like symptoms, it is impossible to contract the coronavirus from the vaccine, because the mRNA vaccines develop by Pfizer and Moderna don’t use the live virus. 

Bottomline

Getting vaccinated is one of many steps you can take to protect yourself and others from COVID-19.  Vaccines work with your immune system so your body will be ready to fight the virus if you are exposed.

References:

  1. https://www.cnbc.com/2020/12/08/pfizer-moderna-covid-vaccine-side-effects-trials.html?__source=iosappshare%7Ccom.microsoft.msedge.EMMXShareExtension
  2. https://www.fda.gov/media/144245/download
  3. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/how-they-work.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fhow-they-work.html
  4. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/vaccine-benefits/facts.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fvaccines%2Fabout-vaccines%2Fvaccine-myths.html

U.S. FDA Approves COVID-19 Plasma Treatment for Emergency Use Authorization

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Eradicating the coronavirus, whether it’s through an effective therapeutic treatment or vaccine, is the key to unlocking the economy.

The U.S. Food and Drug Administration’s granted emergency use authorization of antibody-rich plasma from recovered patients which may lessen the severity of the disease, but experts suggest further research is needed.

Convalescent plasma therapy is an experimental treatment that some physicians are using for people with severe coronavirus disease 2019 (COVID-19). The plasma therapy has shown some promise in battling severe illness. People who’ve recovered from COVID-19 have antibodies — proteins the body uses to fight off infections — to the disease in their blood. The blood from people who’ve recovered is called convalescent plasma.

Researchers hope that convalescent plasma can be given to people with severe COVID-19 to boost their ability to fight the virus. It also might help keep people who are moderately ill from becoming more ill and experiencing COVID-19 complications, according to the Mayo Clinic.

Alex Azar, the U.S. health and human services secretary, said during a White House press briefing on Sunday that the treatment has been delivered to more than 70,000 American patients so far. The treatment, according to the FDA’s evaluation, “may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients.”

Source: The New York Times Coronavirus Vaccine Tracker

Over 400 vaccines and therapietic treatments are under study as researchers rush to produce effective medicines for the disease. And, 32 of the vaccines are in human trials. The FDA says that for any vaccine to be approved, it will need to prevent infection or decrease its severity in at least 50% of the people vaccinated. The goal is to inoculate enough people with a vaccine that immunity spreads through a community, even if not everyone gets the vaccine. It’s called “herd immunity”, according to WebMD.

For this coronavirus, some experts say about 60% to 70% of the population would need to develop antibodies, whether from a vaccine or getting and recovering from COVID-19, to create herd immunity.

Currently, the most effective ways to protect yourself and others from being infected by the virus are to:

  • Clean your hands frequently and thoroughly
  • Avoid touching your eyes, mouth, and nose
  • Cover your cough with the bend of elbow or tissue
  • Stay home and isolate yourself if you feel ill or ‘under-the-weather’
  • Maintain social physical distance of at least 6 feet from others

Wearing a mask or face covering is no substitute for these additional effective measures.

References:

  1. https://www.mayoclinic.org/tests-procedures/convalescent-plasma-therapy/about/pac-20486440
  2. https://www.cnet.com/news/coronavirus-plasma-treatment-approved-for-emergency-use-but-questions-remain/
  3. https://www.webmd.com/lung/news/20200610/covid-19-latest-updates

SalivaDirect – FDA authorizes new saliva based COVID-19 test

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Food and Drug Administration (FDA) commissioner Stephen Hahn called the development of a new and inexpensive saliva test for COVID-19 ”ground-breaking.” The new COVID test, which uses saliva instead of nasal swabs, is also a much less intrusive test than the nasal test.

The Food and Drug Administration on Saturday authorized emergency use of a new and inexpensive saliva test for Covid-19 that could greatly expand testing capacity. The new test is called SalivaDirect and was developed by researchers at the Yale School of Public Health.

The test method allows saliva samples to be collected in any sterile container. And, it is a much less invasive process than the nasal swabs currently used to test for the virus that causes Covid-19, but one that has so far yielded highly sensitive and similar results. This test is being further validated as a test for asymptomatic individuals through a program that tests players and staff from the National Basketball Association (NBA).

SalivaDirect is simpler, less expensive, and less invasive than the traditional method for nasal swab testing. Results so far have found that SalivaDirect is highly sensitive and yields similar outcomes as nasal swabbing.

“We simplified the test so that it only costs a couple of dollars for reagents, and we expect that labs will only charge about $10 per sample,” said Nathan Grubaugh, a Yale assistant professor of epidemiology. “If cheap alternatives like SalivaDirect can be implemented across the country, we may finally get a handle on this pandemic, even before a vaccine.”

With the FDA’s emergency use authorization, the testing method is immediately available to other diagnostic laboratories that want to start using the new test, which can be scaled up quickly for use across the nation. A key component of SalivaDirect is that the method has been validated with reagents and instruments from multiple vendors.

References:

  1. https://khn.org/morning-breakout/fda-signs-off-on-fast-inexpensive-saliva-test/
  2. https://news.yale.edu/2020/08/15/yales-rapid-covid-19-saliva-test-receives-fda-emergency-use-authorization