Michael Coston
Editor, Senior Moderator
Moderna Announcement: HHS Cancellation of HHS Late-Stage Contract To Provide mRNA H5 Vaccine
Credit ACIP/CDC
#18,738
Just over a year ago, in response to the detection of H5N1 in diary cattle, the HHS contracted with CSL Seqirus for 4.8 million doses of a cell-based, adjuvanted, H5 vaccine (using the Astrakhan H5 antigen); enough for about 2.4 million people.
As the H5 threat increased over the fall and winter months, last January the outgoing administration awarded Moderna a $590 Million Dollar Contract To Develop an mRNA H5N1 Vaccine. Almost immediately, the incoming administration announced they would be reviewing that contract.
Despite an excellent safety record, and the added ability to produce large quantities of updated vaccine quickly without relying on antiquated egg-based manufacturing techniques - many people distrust mRNA vaccines; some vehemently.
Admittedly, no vaccine is 100% or benign. With all medicines, there is a risk/benefit calculation to be made, and in most cases the benefits far outweigh any risks.
Overnight Moderna posted the following announcement, providing an encouraging early update on immune responses from the vaccine, followed by the HHS cancellation of the January contract.
Phase 1/2 H5 avian flu vaccine study shows positive interim results
Company has been notified that HHS will terminate Moderna's award for late-stage development of pre-pandemic influenza vaccines
CAMBRIDGE, MA / ACCESS Newswire / May 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype.
The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines.
(SNIP)
The Phase 1/2 study evaluated a two-dose regimen of Moderna's investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline.
(Continue . . . )
The production and deployment of emergency vaccines for a pandemic is often fraught with delays and uncertainty, which makes pre-planning all the more important.
Early experimental H5 (and H7) avian flu vaccines proved poorly immunogenic – requiring unusually large amounts of antigen (up to 12x normal). Adding an adjuvant - spread across two shots several weeks apart - produced a much better immune response (see 2015's JAMA: Immune Response Of H7N9 Vaccine With & Without Adjuvant).
The United States approved an adjuvanted monovalent H5Nx vaccine from Seqirus back in early 2020 (see FDA approval letters), despite concerns over whether Americans will accept an adjuvanted vaccine (which have been used successfully in Europe for years). We've also seen difficulties in producing bulk H5N1 vaccines in the past, particularly in egg-based production facilities (see Manufacturing Pandemic Flu Vaccines: Easier Said Than Done). And of course, because of our current poultry epizootic, the supply of eggs in which to make a vaccine could become a problem.
Even under the best reasonable scenario - using both egg and cell-based technology - it could take months into a pandemic before a vaccine would be widely available (see Maggie Fox's SCI AM - A Bird Flu Vaccine Might Come Too Late to Save Us from H5N1).
According to recent polls (see Two Surveys (UK & U.S.) Illustrating The Public's Lack of Concern Over Avian Flu), most people don't consider HPAI H5 to be a major public health threat. And it is possible they are right. H5Nx could certainly fizzle, or be overtaken by another threat.
I only know that there are a lot of viral contenders out there, and another pandemic is inevitable.
And as we discussed in The Wrong Pandemic Lessons Learned, the world seems to be less well prepared today for another pandemic than we were a decade ago.
While a course correction is badly needed, I fear we may not see one until the pandemic-after-next.
https://afludiary.blogspot.com/2025/05/moderna-announcement-hhs-cancellation.html
Credit ACIP/CDC
#18,738
Just over a year ago, in response to the detection of H5N1 in diary cattle, the HHS contracted with CSL Seqirus for 4.8 million doses of a cell-based, adjuvanted, H5 vaccine (using the Astrakhan H5 antigen); enough for about 2.4 million people.
As the H5 threat increased over the fall and winter months, last January the outgoing administration awarded Moderna a $590 Million Dollar Contract To Develop an mRNA H5N1 Vaccine. Almost immediately, the incoming administration announced they would be reviewing that contract.
Despite an excellent safety record, and the added ability to produce large quantities of updated vaccine quickly without relying on antiquated egg-based manufacturing techniques - many people distrust mRNA vaccines; some vehemently.
Admittedly, no vaccine is 100% or benign. With all medicines, there is a risk/benefit calculation to be made, and in most cases the benefits far outweigh any risks.
Overnight Moderna posted the following announcement, providing an encouraging early update on immune responses from the vaccine, followed by the HHS cancellation of the January contract.
May 28, 2025
Phase 1/2 H5 avian flu vaccine study shows positive interim results
Company has been notified that HHS will terminate Moderna's award for late-stage development of pre-pandemic influenza vaccines
CAMBRIDGE, MA / ACCESS Newswire / May 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype.
The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines.
(SNIP)
The Phase 1/2 study evaluated a two-dose regimen of Moderna's investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline.
The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting.
(Continue . . . )
The production and deployment of emergency vaccines for a pandemic is often fraught with delays and uncertainty, which makes pre-planning all the more important.
Early experimental H5 (and H7) avian flu vaccines proved poorly immunogenic – requiring unusually large amounts of antigen (up to 12x normal). Adding an adjuvant - spread across two shots several weeks apart - produced a much better immune response (see 2015's JAMA: Immune Response Of H7N9 Vaccine With & Without Adjuvant).
The United States approved an adjuvanted monovalent H5Nx vaccine from Seqirus back in early 2020 (see FDA approval letters), despite concerns over whether Americans will accept an adjuvanted vaccine (which have been used successfully in Europe for years).
Even under the best reasonable scenario - using both egg and cell-based technology - it could take months into a pandemic before a vaccine would be widely available (see Maggie Fox's SCI AM - A Bird Flu Vaccine Might Come Too Late to Save Us from H5N1).
According to recent polls (see Two Surveys (UK & U.S.) Illustrating The Public's Lack of Concern Over Avian Flu), most people don't consider HPAI H5 to be a major public health threat. And it is possible they are right. H5Nx could certainly fizzle, or be overtaken by another threat.
I only know that there are a lot of viral contenders out there, and another pandemic is inevitable.
And as we discussed in The Wrong Pandemic Lessons Learned, the world seems to be less well prepared today for another pandemic than we were a decade ago.
While a course correction is badly needed, I fear we may not see one until the pandemic-after-next.
https://afludiary.blogspot.com/2025/05/moderna-announcement-hhs-cancellation.html