JNJ COVID-19 vaccine receives FDA emergency use authorization – great news

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On 26 February 2020, the Johnson and Johnson (JNJ) COVID-19 vaccine underwent an FDA expert review, similar to the ones for the Pfizer and Moderna COVID-19 vaccines. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of the third vaccine in the USA to prevent COVID-19. On 27 February 2020, the USFDA gave clearance for an Emergency Use Authorization (EUA).

VRBPAC agreed that the vaccine was very effective, especially in preventing death and serious COVID-19 disease. They also found no serious safety signals, with the incidence serious adverse events were no higher compared to the placebo group or what would be expected in the general population.

The EUA approved the vaccine for use in adults 18 and older. Before JNJ can ship the vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet tomorrow to make recommendations on who can receive this vaccine.

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Johnson and Johnson COVID-19 vaccine scientific facts

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On 26 February 2020, the Johnson and Johnson (JNJ) COVID-19 vaccine underwent an FDA expert review, similar to the ones for the Pfizer and Moderna COVID-19 vaccines. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of the third vaccine in the USA to prevent COVID-19. This vote by the vaccine experts is the last step in advance of FDA clearance for an Emergency Use Authorization (EUA).

This article will review the key points about the Johnson and Johnson COVID-19 vaccine’s safety, effectiveness, ingredients, and other critical information. This scientific information should answer a lot of questions about the vaccine that will inevitably arise over the next few weeks.

This will be different than my myth debunking article (which will be constantly updated as the anti-vaxxers get going with their lies and disinformation), as this article will try to make sure that everyone is on the same page with what this vaccine is. 

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JNJ seeking emergency use authorization for its COVID-19 vaccine

JNJ COVID-19 vaccine

Pharmaceutical giant Johnson and Johnson (JNJ) has submitted an application for an emergency use authorization (EUA) for its COVID-19 vaccine. In phase 3 clinical trials, results showed that it was effective against the illness, and it was especially robust in preventing severe cases of COVID-19 along with death.

The COVID-19 vaccine, which was developed by JNJ subsidiary Janssen Biotech, will be reviewed by an FDA advisory committee on 26 February 2021. If that review goes well, the FDA Commissioner could issue the EUA within a few days.

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Moderna COVID-19 vaccine – FDA approves emergency use authorization

moderna COVID-19 vaccine

On 17 December 2020, the Moderna COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). VRBPAC gave an overwhelming recommendation for the vaccine, and the FDA issued the EUA today.

This article will quickly review the major points about the VRBPAC discussion, a review of some of the data, and finally a summary of what we know and don’t know about the Moderna COVID-19 mRNA vaccine. 

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Pfizer COVID-19 mRNA vaccine – FDA approves emergency use authorization

pfizer COVID-19 mRNA vaccine

On 10 December 2020, the Pfizer/BioNTech COVID-19 mRNA vaccine was reviewed by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in advance of an emergency use authorization (EUA). Unless you were avoiding the internet (and hence, you wouldn’t be reading this), you would know that the review went well, and VRBPAC “approved” the vaccine. On the evening of 11 December, the FDA gave approval for the EUA, the first COVID-19 vaccine available in the USA.

This article will quickly review the major points about the VRBPAC discussion, a review of some of the data, and finally a summary of what we know and don’t know about the Pfizer COVID-19 mRNA vaccine. 

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ACIP COVID-19 vaccine priority proposal – healthcare workers first

ACIP COVID-19 vaccine priority

On 1 December 2020, the CDC’s Advisory Committee on Immunization Practices (ACIP) COVID-19 vaccine priority recommendations were discussed. As I have written recently, Pfizer, Moderna, and AstraZeneca all have announced that their vaccines exhibited high effectiveness and safety during phase 3 clinical trials, while both the Pfizer and Moderna vaccines are seeking emergency use authorizations (EUA) from the US Food and Drug Administration (FDA), so these vaccines may become available within a few weeks.

This is a brief review of the ACIP and CDC COVID-19 vaccine priority lists for the first tranches of vaccines.

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Pfizer COVID-19 vaccine review scheduled for December 10 by FDA

pfizer COVID-19 vaccine review

The US Food and Drug Administration (FDA) has announced a Pfizer COVID-19 vaccine review meeting for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on 10 December 2020. It is intended to discuss and review the emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine.

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Moderna COVID-19 vaccine – more good news that requires skepticism

Like Pfizer announced recently, Moderna Therapeutics has released preliminary results for its COVID-19 vaccine. And like Pfizer, Moderna’s data is very exciting but, and there’s always a but, the data has not been peer-reviewed or analyzed independently.

To be fair, I’ve been highly critical of Moderna because of their lack of transparency and the overreliance on press releases to boost their stock prices. For many pharmaceutical companies, like Merck or Pfizer, vaccines make up only a tiny portion of their revenue and profits. For Moderna, their whole reason for existence is vaccines. So if they have a blockbuster vaccine, their stock prices skyrocket. 

That being said, there are some reasons to get somewhat more excited about the Moderna COVID-19 vaccine over the Pfizer one. So, let’s take a look.

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