Approved July 2022 Novavax: New COVID Vaccine May be Available Soon

Posted by Dana, Volunteer Mentor @danab, Jul 28, 2021

I'm excited to see a new COVID vaccine named Novavax making great progress in third phase trials. It uses a more traditional approach similar to the yearly flu vaccine. This makes me more comfortable to get vaccinated. Looking forward to hearing that it will receive the go ahead to distribute soon. The current timetable is to finish trials this month and apply for FDA approval sometime in September. You can read more about the Novovax vaccine in these articles:
https://www.verywellhealth.com/novavax-covid-19-vaccine-5093292
https://www.verywellhealth.com/novavax-additional-covid-vaccines-united-states-5190372

Interested in more discussions like this? Go to the Post-COVID Recovery & COVID-19 Support Group.

@ktgirl

Are there any new vaccines coming soon?

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Ktgirl, I moved your question to this discussion about the Novavax vaccine. @danab is watching its development closely.

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Are there any new vaccines coming soon?

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@merpreb

It seems that more tracking is done by the UK and Israel. It feels as if the US has given up on this type of tracking.

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I did some more looking. Not sure why they got that response at the hospital, but drugs under EUA are tracked on an FDA system called MedWatch. Adverse events are required to be reported.
Sue

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@sueinmn

Wow! That surprises me since all of these meds are being used for Covid either with EUA (Emergency Use Authorization) or off-label, I would have assumed all were being tracked.
Bamlanivimab was under an EUA. How will we ever know its safety or effectiveness if it is not tracked?

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It seems that more tracking is done by the UK and Israel. It feels as if the US has given up on this type of tracking.

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@connie1977

Thank you for the information. It was very informative. I would like to add, however, when my husband and I received the monoclonal antibody therapy, we offered to be available if the hospital needed follow up information. We were told it was not necessary, they weren't going to track the patients who received it.

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Wow! That surprises me since all of these meds are being used for Covid either with EUA (Emergency Use Authorization) or off-label, I would have assumed all were being tracked.
Bamlanivimab was under an EUA. How will we ever know its safety or effectiveness if it is not tracked?

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Thank you for the information. It was very informative. I would like to add, however, when my husband and I received the monoclonal antibody therapy, we offered to be available if the hospital needed follow up information. We were told it was not necessary, they weren't going to track the patients who received it.

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@danab

Hi Everyone a little update on a couple of fronts, I just watched an update from Dr Poland during a q&a with the Arizona Doctors and at the 1 hr 4 min mark he mentioned that the Novavax Vaccine according to the numbers he is seeing is a great candidate. And advised to stay tuned for that one becoming available.

In the news I see manufacturer delays are causing the company to wait until 4th quarter for FDA filing for EUA use son hoping it becomes an option soon
Here is the link to the video.


Blessing

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Thank you Dana.

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@connie1977

I just wanted to update my situation. It has been 9 months after coming down with Covid-19 and being given Bamlanivimab monoclonal antibody therapy. I was just retested this week and I still have antibodies. However, my husband who had Covid and received Bamlanivimab no longer has antibodies so he received the Johnson and Johnson vaccination. I am masking up (required where I live) but am hoping my antibodies will carry me over until Novovax becomes available.
To me it seems there is no follow up on who received monoclonal antibody therapy and their reaction to the different vaccinations. Also the fully vaccinated people who test positive for Covid months later after vaccination ... which vaccination was received? Other countries are publishing this data but in the US, it is silent here. Other people in the medical field has voiced this concern.

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You can read about the CDC tracking of breakthrough infection tracking here: https://www.cdc.gov/vaccines/covid-19/health-departments/breakthrough-cases.html For some reason, back in May the CDC decided to track only those cases which resulted in hospitalization or death.

Many states are still doing comprehensive breakthrough tracking. Minnesota reports theirs weekly in their comprehensive Covid-19 report: https://www.health.state.mn.us/diseases/coronavirus/stats/vbt.html The latest report shows the total number of Covid positive cases reported in Minnesota after full vaccination (14 days after completed vaccine process. ) Here are the Minnesota numbers for February through August:
Total cases: (5,640,000 population)
190,000 positive tests (3300/100,000)
11,000 hospitalizations (195/100,000)
1,175 deaths (21/100,000)
Fully Vaccinated cases: (3,000,000 or 53% of population)
12,559 positive tests (220/100,000)
810 hospitalizations (14/100,000)
80 deaths (1.4/100,000)
That means about 7% of cases, hospitalizations and deaths are occurring in the vaccinated population (53% of the state) and 93% are in the unvaccinated people (47% of the state)
We could repeat this exercise state by state, but it reflects what the hospitals and health departments are reporting nationwide.

As to which vaccines experience the most breakthrough, the best information I could find was in VAERS, where about 12,600 have reported a positive Covid test after vaccination (but we don't know how long after or how many doses they had received.) This is a self-reporting system typically used to report vaccine reactions, so we don't know if people used it to report subsequent infections or not. It just gives some idea of the ratio of reported positives to total vaccine doses.
By vaccine:
Johnson & Johnson 889 cases (14 million doses)
Moderna 3,876 cases (66 million doses)
Pfizer 7,870 cases (95 million doses)

As to tracking vaccination information for people who have received monoclonal antibodies, I cannot see how that could be tracked. People receive these for hundreds of diseases and conditions in addition to Covid treatment. There is no requirement, upon receiving the Covid vaccine, to list every current and/or previous medication ever taken, which would be the only way gather this data. During vaccine testing, conditions and medications were tracked, so any known contraindications would have been noted.

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I just wanted to update my situation. It has been 9 months after coming down with Covid-19 and being given Bamlanivimab monoclonal antibody therapy. I was just retested this week and I still have antibodies. However, my husband who had Covid and received Bamlanivimab no longer has antibodies so he received the Johnson and Johnson vaccination. I am masking up (required where I live) but am hoping my antibodies will carry me over until Novovax becomes available.
To me it seems there is no follow up on who received monoclonal antibody therapy and their reaction to the different vaccinations. Also the fully vaccinated people who test positive for Covid months later after vaccination ... which vaccination was received? Other countries are publishing this data but in the US, it is silent here. Other people in the medical field has voiced this concern.

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@danab

Hi Everyone a little update on a couple of fronts, I just watched an update from Dr Poland during a q&a with the Arizona Doctors and at the 1 hr 4 min mark he mentioned that the Novavax Vaccine according to the numbers he is seeing is a great candidate. And advised to stay tuned for that one becoming available.

In the news I see manufacturer delays are causing the company to wait until 4th quarter for FDA filing for EUA use son hoping it becomes an option soon
Here is the link to the video.


Blessing

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Interesting. Thank you for sharing.

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