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FDA Approves JNJ & MRNA's COVID-19 Boosters & Mixing of Doses
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The FDA has granted emergency use authorization (“EUA”) to booster doses of Johnson & Johnson’s (JNJ - Free Report) single-shot COVID-19 vaccine and Moderna’s (MRNA - Free Report) mRNA-based COVID-19 vaccine, mRNA-1273. The United States now has authorized booster doses of three COVID-19 vaccines. The third vaccine is Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) mRNA-based vaccine, Comirnaty, whose booster dose was authorized by the FDA last month.
In an unexpected turn of events, the FDA also authorized the mix and match or heterologous administration of the booster doses of the three COVID-19 vaccines. The heterologous administration will allow inoculation of an individual with any of the three available booster jabs irrespective of the initial COVID-19 vaccine regimen.
Booster Dose Eligibility
J&J’s booster dose is now authorized for use in all adults who have completed at least two months of their primary vaccination with J&J’s single-shot COVID-19 vaccine. Moderna received authorization for emergency use of the booster dose of mRNA-1273 after at least six months of the initial two-dose regimen in people aged 65 years or older (elderly), and in adults aged 18 or older who at high risk of severe COVID-19 or whose exposure to COVID-19 puts them at a risk of complications or severe illness. Comirnaty’s booster dose is also authorized for a similar population and dosing interval as Moderna’s vaccine.
The mix-and-match administration will allow administration of J&J’s booster jab in elderly and high-risk adults who have received mRNA-1273 or Comirnaty during the initial regimen and after at least six months of primary vaccination. In a similar manner, the booster dose of mRNA-1273 or Comirnaty can be administered to all adults who have received J&J’s single-shot vaccine initially following a dosing interval of two months.
Shares of all the aforementioned COVID-19 vaccine makers were up in after-hours trading on Oct 20, following the unexpected heterologous administration authorizations.
Why Mix and Match?
The FDA authorized the mix and match administration based on clinical data from study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The data demonstrated that the benefits of the use of a single heterologous booster dose outweigh risks.
Several health experts have been voicing support for the mix and match administration of booster doses for a better vaccination program. There have been cases of allergic reactions in individuals receiving a certain COVID-19 vaccine. Some regions in the United States do not have all the three booster vaccines available simultaneously. The heterologous administration will alleviate these shortcomings. A person who has had a side-effect after receiving a mRNA-based vaccine can be administered J&J’s adeno-virus based booster vaccine and vice-versa. Moreover, the availability of any of the authorized booster doses in a region will allow the booster vaccination program to continue.
Also, the FDA’s authorization of heterologous administration will ease the concerns related to use of a different booster jab than the initial regimen.
Image: Bigstock
FDA Approves JNJ & MRNA's COVID-19 Boosters & Mixing of Doses
The FDA has granted emergency use authorization (“EUA”) to booster doses of Johnson & Johnson’s (JNJ - Free Report) single-shot COVID-19 vaccine and Moderna’s (MRNA - Free Report) mRNA-based COVID-19 vaccine, mRNA-1273. The United States now has authorized booster doses of three COVID-19 vaccines. The third vaccine is Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) mRNA-based vaccine, Comirnaty, whose booster dose was authorized by the FDA last month.
In an unexpected turn of events, the FDA also authorized the mix and match or heterologous administration of the booster doses of the three COVID-19 vaccines. The heterologous administration will allow inoculation of an individual with any of the three available booster jabs irrespective of the initial COVID-19 vaccine regimen.
Booster Dose Eligibility
J&J’s booster dose is now authorized for use in all adults who have completed at least two months of their primary vaccination with J&J’s single-shot COVID-19 vaccine. Moderna received authorization for emergency use of the booster dose of mRNA-1273 after at least six months of the initial two-dose regimen in people aged 65 years or older (elderly), and in adults aged 18 or older who at high risk of severe COVID-19 or whose exposure to COVID-19 puts them at a risk of complications or severe illness. Comirnaty’s booster dose is also authorized for a similar population and dosing interval as Moderna’s vaccine.
The mix-and-match administration will allow administration of J&J’s booster jab in elderly and high-risk adults who have received mRNA-1273 or Comirnaty during the initial regimen and after at least six months of primary vaccination. In a similar manner, the booster dose of mRNA-1273 or Comirnaty can be administered to all adults who have received J&J’s single-shot vaccine initially following a dosing interval of two months.
Shares of all the aforementioned COVID-19 vaccine makers were up in after-hours trading on Oct 20, following the unexpected heterologous administration authorizations.
Why Mix and Match?
The FDA authorized the mix and match administration based on clinical data from study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). The data demonstrated that the benefits of the use of a single heterologous booster dose outweigh risks.
Several health experts have been voicing support for the mix and match administration of booster doses for a better vaccination program. There have been cases of allergic reactions in individuals receiving a certain COVID-19 vaccine. Some regions in the United States do not have all the three booster vaccines available simultaneously. The heterologous administration will alleviate these shortcomings. A person who has had a side-effect after receiving a mRNA-based vaccine can be administered J&J’s adeno-virus based booster vaccine and vice-versa. Moreover, the availability of any of the authorized booster doses in a region will allow the booster vaccination program to continue.
Also, the FDA’s authorization of heterologous administration will ease the concerns related to use of a different booster jab than the initial regimen.
While Pfizer carries a Zacks Rank #2 (Buy), Moderna, J&J and BioNTech carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.