ARMCHAIR AMERICAN: A VIEW FROM THE CENTER
  • Home
  • Blog
  • About Me
  • Subscribe
Picture

COVID-19 Vaccine Update. Johnson&Johnson Vaccine Gets Emergency Use Authorization.

2/28/2021

0 Comments

 
Picture
​It has been over two months since my last BLOG on COVID-19 vaccines. Since that time millions of people in several different countries have been vaccinated, new vaccines have been approved for use, and new virus variants have emerged. This blog is about the latest developments on the COVID-19 vaccine front.
Picture
Johnson & Johnson (J&J) Vaccine: The J&J vaccine was given Emergency Use Authorization by the F.D.A. on February 27, 2021. According to Johnson & Johnson’s press release, the vaccine was 72% effective at preventing moderate to severe COVID-19 infections in the U.S. (https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial). What this means is the vaccine prevented all illness, including mild symptoms, in 72% of the recipients of the vaccine. This may sound disappointing in comparison to the 94-95% efficacy of the Pfizer-BioNTech and Moderna vaccines, but it was highly effective at limiting serious disease. J&J’s vaccine was 85% effective overall at preventing serious illness across all regions that it studied (U.S., Argentina, Brazil, Chile, Columbia, Mexico, Peru, and South Africa). More importantly, the vaccine demonstrated complete protection against COVID-19 related hospitalizations and deaths, the true benchmarks of the success of this vaccine.

The vaccine had an overall efficacy rate of 64% against the more virulent South African strain, but an 82% rate against serious illness. It is important to note that the J&J trials were conducted when more variants were circulating in the population than when the Pfizer-BioNTech and Moderna trials were being conducted. This could account for the reduced efficacy being reported in the U.S. and elsewhere. Here are the key attributes of this new vaccine:
​
  • Single Shot: Only a single shot is needed, unlike the Pfizer-BioNTech and Moderna which require a second shot, 3-4 weeks after the first. Even though the vaccine is effective after one dose, studies are underway to determine if a second dose would increase its protective effects.
  • Stable at Refrigeration Temperature: The vaccine can be transported and stored at typical refrigeration temperatures (36-46°F), for at least three months. It has a shelf life of two years when frozen.
  • Mild Side Effects: The side effects are milder than experienced with the Pfizer-BioNTech and Moderna vaccines. However, two people who were not part of the trial, were recently reported to have experienced severe allergic reactions after receiving the vaccine. It is unclear at this time if the allergic reactions were directly linked to the J&J vaccine.
  • Limited Supplies: Four million doses are available for immediate shipment, and 16 million more will be shipped within the U.S. by the end of March. J&J stands by its commitment to deliver 100 million doses to the U.S. government by the end of June 2021.
​
The J&J vaccine is a breakthrough. It doesn’t need sophisticated freezers for transport and storage, making it accessible to remote and underserved areas, as well as in second and third world countries. The fact that it is effective after a single dose makes it a great choice when scheduling a second shot is problematic, such as in homeless populations, the homebound, migrant farm workers, and hard to reach populations around the world. If I was the vaccine czar, the J&J vaccine would be reserved for these vulnerable populations.  
​
Picture
​Pfizer-BioNTech Vaccine: On February 12, 2021, Pfizer-BioNTech announced that the U.S. government had exercised its option to purchase an additional 100 million doses of their vaccine. This brings the total number of doses to be supplied to the U.S. to 300 million, enough for 150 million people. Here are some recent developments:
​
  • Efficacy in Children: There is a study currently underway to determine the efficacy in children ages 12-15 years. The study should be completed by the end of March.
  • Efficacy in Pregnant Women: On February 15, 2021 Pfizer-BioNTech began a trial to determine the safety and effectiveness of its vaccine in pregnant women.  The trial has enrolled 4000 women in the third trimester of pregnancy, and the results should be known sometime this summer.
  • Efficacy Confirmed in Real World Study: An Israeli study published on February 17, 2021 in the New England Journal of Medicine, established the efficacy of the Pfizer-BioNTech vaccine in a nation-wide study of over 500,000 people (https://www.nejm.org/doi/10.1056/NEJMoa2101765). This study showed overall efficacy of 94%, confirming the data supplied to the F.D.A. from the much smaller Phase 3 trial. The results of the study showed significant reduction in hospitalizations and deaths in the general population, giving validity to the need for widespread vaccination against COVID-19.   
  • Storage Requirements Eased: On February 25, 2021 the F.D.A. announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech vaccine to be transported and stored at normal freezer temperatures (-13°F to 5°F) for up to two weeks (https://www.fda.gov/media/144413/download). The vials may be returned to ultra-low temperatures (-112°F to -76°F) on a one-time basis for long-term storage, if needed.  Previous to this change, the vaccine was required to be stored at ultra-low temperatures. The two- week window of eased storage requirements will provide much needed flexibility of how this vaccine is transported, and opens up many more vaccination sites.  
  • Only One Dose Needed in Previously Infected People: Two new studies from Britain, reported in the medical journal The Lancet (https://www.thelancet.com/action/showPdf?pii=S0140-6736%2821%2900502-X), showed that a single dose of the Pfizer-BioNTech vaccine is enough to provide robust protection from the coronavirus in previously infected people. This is an important development which may free up more vaccine for people who have no current immunity. There have been approximately 30 million Americans infected with the coronavirus and 113 million people worldwide.
Picture
​​Moderna Vaccine: On February 11, 2021 Moderna announced that the U.S. government had agreed to purchase an additional 100 million doses of its vaccine. This brings the total confirmed order commitment to 300 million doses, enough to fully vaccinate 150 million Americans. Moderna is on track to deliver the first 100 million doses in the first quarter of 2021, the next 100 million in the second quarter, and the new order of 100 million doses by the end of July 2021. Even without any new vaccines becoming available, the U.S. now has enough contracted vaccines to cover all of its eligible citizens, and then some.  Here are some recent developments:
​
  • Increasing Number of Doses in Each Vial: On February 12, 2021 the F.D.A. informed Moderna that it may put up to 40% more COVID-19 vaccine in each of its vials. Moderna is currently approved to put ten doses in each vial. The F.D.A. wants Moderna to submit additional data to support its claim that the additional volume will not compromise vaccine quality. Retooling of the manufacturing process may take until the end of April, but this could provide a much-needed boost to the supply of vaccines worldwide.
  • Modified Vaccine to Fight South African Variants: On February 24, 2021 Modern announced that it had developed a modified version of its COVID-19 vaccine to increase effectiveness against the South African variant (https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-it-has-shipped-variant-specific-vaccine). This new variant-specific vaccine candidate has been submitted to the National Institutes of Health for review.
  • Efficacy in Children: Moderna has begun a trial to test the efficacy of its vaccine in children ages 12-17. The company is having a difficult time enrolling enough trial participants, so I wouldn’t expect any results until late in the year. 
Picture
​AstraZeneca/University of Oxford Vaccine: This vaccine was first approved for emergency use in the United Kingdom on December 30, 2020 for individuals 18 years of age and older. The vaccine requires a two-dose regimen, with an interval of between four and twelve weeks between doses. There has been some debate about the actual efficacy of the vaccine, with ranges from 62-82%. But clinical trials in the United Kingdom have shown the vaccine to be safe and highly effective at reducing hospitalizations and deaths. Because of the confusion over some of the reported data, the U.S. is conducting a trial of its own. Approval in the U.S. may still be a few months away. The vaccine can be transported and stored at normal refrigeration temperatures (36-46°F) for at least six months, making it a good candidate for use in 2nd and 3rd world countries. Here are some recent developments:
​
  • World Health Organization Approves Use: The WHO granted “Emergency Use Listing” of the vaccine for its member organizations, such as the COVAX Alliance, on February 15, 2021.  
  • Approved for Use by the European Union: The EU approved the use of the vaccine by its member countries on January 29, 2021 for people 18 years of age and older. Some EU countries, such as France and Germany, don't recommend the vaccine for  any of their citizens 65 years of age or older. They do not believe that the clinical trials included enough older participants to conclude efficacy in this age group.  AstraZeneca is currently conducting additional clinical trials in people 55 years of age and older.  
  • Canada Approves Use: The Canadian government approved the use of the vaccine on February 26, 2021 for people 18 years of age and older.
Picture
​Novavax: On January 28, 2021, Novavax announced that its vaccine demonstrated 89% efficacy in a Phase 3 clinical trial conducted in the United Kingdom (https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3).  Preliminary studies suggest that it is very effective at preventing severe disease from the South African strain of COVID-19. Phase 3 clinical trials are underway in Mexico and the U.S. and should be concluded by the end of March. The vaccine requires two-doses, but doesn’t require the strict storage requirements of the Pfizer-BioNTech or Moderna vaccines.   

In September Novavax entered into an agreement with a major Indian vaccine manufacturer that could produce up to 2 billion doses per year. The U.S. has an agreement to purchase up to 110 million doses, with most of the remaining doses going to the COVAX Alliance. Look for this vaccine to be approved for use in the second half of 2021.
​
There are currently 71 COVID-19 vaccines in clinical trials on humans, 20 of these have reached large scale Phase 3 trials around the world. In addition to the five vaccines that I detailed above, China has two vaccines it has approved for use, Russia has one vaccine, as does India.  
Picture
​Virus Variants: The longer the novel coronavirus circulates, the more people that become infected, giving the virus opportunities to mutate into more dangerous variants. Any new variant has the potential of being more contagious, result in more severe illness, and be resistant to currently available vaccines. This is why it is so important to speed up the rate of vaccinations and to continue safe practices, until herd immunity is reached. Widespread testing for COVID-19 is very important to monitor the development and spread of new variants.  Here are some of the new variants which have recently been identified:

  • British Variant (B.1.1.7): This variant was first identified in Great Britain and now is widespread in the U.S. and at least 48 other countries. The Pfizer-BioNTech, Moderna, and J&J vaccines are effective against this variant, but it has been shown to be more contagious (transmissible)  than the original Chinese variant.  
  • Californian variant (B.1429/B.1.427): This variant now causes more than half of the infections in the U.S. and in 44 other countries. Preliminary studies have shown this variant to be more transmissible than previous strains, and has the potential to cause more severe illness. The Pfizer-BioNTech, Moderna, and J&J vaccines are effective against this variant.
  • South African Variant (B.1.3510): The concern with this variant is that it spreads rapidly and the currently available vaccines are less effective against it. Moderna has developed a modified version of its vaccine to deal with this variant. It is currently under review. Pfizer-BioNTech and Novavx are working on modifications to their vaccines and are testing different dosing regimens against this variant. The J&J vaccine is currently in use in South Africa and it appears to be effective at preventing hospitalizations and deaths.
  • New York Variant (B.1.526): This variant is spreading rapidly in New York City, now causing about 25% of all COVID-19 infections. It shares similar characteristics to the South African and Brazilian variants, both of which result in reduced vaccine effectiveness.
  • Brazilian Variant (P.1): First detected in the U.S. in January, and now is circulating widely. Like the other variants, it appears to be more transmissible than previous strains. 
Picture
​Vaccine Equity: As of this writing approximately 240 million doses of vaccine have been administered around the world (https://www.cnn.com/interactive/2021/health/global-covid-vaccinations/). According to the United Nations, ten countries administered 75% of all vaccines, and 130 countries have yet to receive a single dose. The COVAX Alliance, led by the World Health Organization, is working with rich countries to provide vaccines to poor ones. But it is off to a slow start. COVAX delivered its first shipment of 600,000 doses of the AstraZeneca vaccine to Ghana on February 24, 2021. Ghana is one of 190 countries which have signed up to receive vaccines through the alliance.  The COVAX Alliance currently has agreements with AstraZeneca and Novavax for COVID-19 vaccines, but the numbers are far short of what is needed. It is important to remember that no one is immune from COVID-19 until we are all immune.
Picture
What We Still Don’t Know: We are a year into this pandemic, vaccines have only been available in limited supply for about two months, and there are a lot of unanswered questions. Once vaccinated, are people still able to spread the virus? Once vaccinated, how long will immunity last? If you had COVID-19, how long does immunity last? When will herd immunity be reached? Well, this is the real question, and we all need to be patient.
​
As of today, about 14.6% of the U.S. population has received at least one shot of vaccine, and a tiny fraction of the world’s population has been vaccinated. It is important to get vaccinated when it is your turn, but it is also important to continue to wear your face mask, practice social distancing and continue using good hygiene. We can't afford to let our guard down now that there is light at the end of the tunnel. We won't know that herd immunity has been reached until new cases of COVID-19 infections are rare.  

The speed with which the various COVID-19 vaccines have been developed and gotten into peoples’ arms is truly remarkable. All of the vaccines currently available in the U.S. are highly effective at minimizing serious illness and death. Coronaviruses have been circulating within the human population for centuries, and the coronavirus that causes COVID-19 will be with us for a long time. The sooner that the majority of the world’s population becomes vaccinated, the sooner the pandemic will be over, and the quicker we will all return to a semblance of “normalcy”.

​
 
If you enjoy reading this type of commentary please subscribe to my blog and tell a friend. You will receive an email notification when new blogs are posted. The email will come from the site’s email: armchairamerican1776 @gmail.com.
​

Thanks,
Armchair American
0 Comments



Leave a Reply.

    Author

    The Armchair American.

    Picture

    Archives

    November 2024
    October 2024
    September 2024
    August 2024
    July 2024
    June 2024
    May 2024
    March 2024
    February 2024
    January 2024
    December 2023
    November 2023
    October 2023
    September 2023
    August 2023
    July 2023
    June 2023
    May 2023
    April 2023
    March 2023
    February 2023
    January 2023
    December 2022
    November 2022
    October 2022
    September 2022
    August 2022
    July 2022
    June 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020

    Categories

    All
    14th Amendment
    1st Amendment
    2020 Presidential Election
    2021
    2024 Election
    2024 Presidential Primary
    2nd Amendment
    4th Of July
    Afghanistan War
    American Flag
    American Rescue Plan
    August 2023
    Black Lives Matter
    Border
    Border Politics
    California Recall
    Camino De Santiago
    Cancel Culture
    Capitol Riot
    Character
    China
    Chris Christie
    Christianity
    Clarence Thomas
    Cluster Bombs
    Concord And Lexington
    Confederate Statues
    Congress
    COVID Pandemic
    COVID Tests
    Crime
    Crossfire Hurricane
    Debt Ceiling
    Democratic Convention
    Donald Trump
    Durham Report
    Electoral College
    Extremism
    FaceMasks
    Father Serra
    FBI
    Filibuster
    Guns In America
    Hilliary Clinton
    Horowitz Report
    House Of Representatives
    Immigration
    Impeachment Inquiry
    Independents
    IRS
    James Comey
    January 6th Committee
    J.D. Vance
    Joe Biden
    Kamala Harris
    Kevin McCarthy
    Mar-a-Lago
    Matt Gaetz
    Midterm Elections
    Mike Pence
    Militias
    Mitch McConnell
    Moore V. Harper
    Mueller Report
    NATO
    Nikki Haley
    NRA
    Olympics
    Open Primaries
    Politics
    Presidential Leadership
    Presidential Pardon
    Presidential Power
    Presidential Records
    Prop 47
    Public Health
    Putin
    QAnon
    Rank Choice Voting
    Republican Convention
    Revolutionary War
    Robinhood
    Ron DeSantis
    Russia
    Russia Probe
    Sanewashing
    Senate Disfunction
    Smash And Grab Roberries
    Socialism
    Supreme Court
    Swift Boating
    Taxes
    Terrorism
    Third-Party Candidates
    Tim Walz
    Title 42
    Trump
    Trump Indicted
    Trumpism
    Tucker Carlson
    UAP
    UFOs
    Ukraine
    Unidentified Aerial Phenomena
    Updates
    Vaccine Boosters
    Vaccines
    Voting
    Voting Rights
    VP Debate
    Zelensky

    RSS Feed

Subscribe to Blog
Contact me at [email protected]
Site powered by Weebly. Managed by Bluehost
  • Home
  • Blog
  • About Me
  • Subscribe