SARS-CoV-2 Vaccine development update

[KSRdallen]

Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2

https://www.businesswire.com/news/home/20200701005576/en/Pfizer-BioNTech-Announce-Early-Positive-Data-Ongoing#.XvyLCJ2YS34.twitter

[Darrell KSR]

Thanks--I'm all for good news these days, and that looks like some of the best I've seen.

I did not spend a great deal of time reading through it, and there was a lot of medical discussion that is over my head and I didn't attempt to read, but was there any discussion directed toward how effective they believe it may be? Did I see multiple doses of the vaccine being indicated?

Thanks--I love that we have experts on this board in so many important areas.

[dan_bgblue]

Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 202

Similar to Darrell's comments where there is a lot of language I do not understand, but the quoted part above is very positive news in my mind as if they are willing to spend money to gear up for potential manufacture of that number of doses indicates to me that they are confident in the end results of treatment using the new drug and ar also confident of it gaining approval from the Feds. My ignorance in such matters is showing itself and such actions by pharma companies may be the norm and they may do this for every drug of even modest potential, but i still choose to view it as a good sign.

Thanks for Sharing DAllen, and when you can, if you do not mind, would you take the time to translate the greek into readable Kentuckyese?

[KSRdallen]

Thanks--I'm all for good news these days, and that looks like some of the best I've seen.

I did not spend a great deal of time reading through it, and there was a lot of medical discussion that is over my head and I didn't attempt to read, but was there any discussion directed toward how effective they believe it may be? Did I see multiple doses of the vaccine being indicated?

Thanks--I love that we have experts on this board in so many important areas.

Efficacy studies will begin later this summer (possibly this month). This study was for two doses which is not uncommon (e.g. Shingrix).

[KSRdallen]

Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 202

Similar to Darrell's comments where there is a lot of language I do not understand, but the quoted part above is very positive news in my mind as if they are willing to spend money to gear up for potential manufacture of that number of doses indicates to me that they are confident in the end results of treatment using the new drug and ar also confident of it gaining approval from the Feds. My ignorance in such matters is showing itself and such actions by pharma companies may be the norm and they may do this for every drug of even modest potential, but i still choose to view it as a good sign.

Thanks for Sharing DAllen, and when you can, if you do not mind, would you take the time to translate the greek into readable Kentuckyese?

Dan, these are early trials which are showing positive results compared to placebo. Antibody development is key and it looks good from the study as well as the fact that the vaccine was well tolerated with only mild to moderate local or systemic (in the body) reactions to the injection.

Also, that they have four vaccine candidates and they are testing them in parallel is also positive and they will run with the one that looks best. Late 2020 is optimistic, but even Anthony Fauci, who is pretty conservative by nature in making such statements, believes this year is possible.

[Darrell KSR]

Thanks, Dr.

[PedroDaGr8]

Overall this is about as promising as preliminary data can get.. The fact that they are seeing solid antibody formation (and in particular titers) above the level seen in recovered patients is likely very important. I haven't looked in detail but I believe, if approved, this would be the first approved RNA vaccine. It is a new technology, which could be used for a number of other viruses.

The 30µg group had a pretty high side effect rate, even if relatively minor: 75% of patients in the 30µg group experienced a fever >100°F after the second dose. On the one hand, this indicates a VERY strong immune response to the second injection. On the other hand, a fever >100°F is not fun and will impede vaccination rates. Considering the 10µg group only had an 8.3% fever rate but still had a mean titer 1.8x of the convalescent group (compared to 2.8x for the 30µg group) , I wouldn't be surprised if they go with a dose closer to 10µg.



Dan, these are early trials which are showing positive results compared to placebo. Antibody development is key and it looks good from the study as well as the fact that the vaccine was well tolerated with only mild to moderate local or systemic (in the body) reactions to the injection.

Also, that they have four vaccine candidates and they are testing them in parallel is also positive and they will run with the one that looks best. Late 2020 is optimistic, but even Anthony Fauci, who is pretty conservative by nature in making such statements, believes this year is possible.

Note they indicate a Phase IIb/III trial is scheduled. This could allow them to test combinations of the four as well under the IIb portion if they believe it could provide greater efficacy at a lower side-effect risk.

Bill Gates has also been funding the manufacturing scale up and validation of 16 different vaccines (not sure if this is one of them) to help the vaccine come to market faster. I can't understate how much "pre-loading" this part of the process will reduce time to market. Scale-up, equipment validation, process validation, etc. all take a significant amount of time and are critical to ensuring the manufacturing process is safe. By doing it now you are cutting multiple months off of the time it takes to produce the vaccine(s).

[KSRdallen]

Overall this is about as promising as preliminary data can get.. The fact that they are seeing solid antibody formation (and in particular titers) above the level seen in recovered patients is likely very important. I haven't looked in detail but I believe, if approved, this would be the first approved RNA vaccine. It is a new technology, which could be used for a number of other viruses.

The 30µg group had a pretty high side effect rate, even if relatively minor: 75% of patients in the 30µg group experienced a fever >100°F after the second dose. On the one hand, this indicates a VERY strong immune response to the second injection. On the other hand, a fever >100°F is not fun and will impede vaccination rates. Considering the 10µg group only had an 8.3% fever rate but still had a mean titer 1.8x of the convalescent group (compared to 2.8x for the 30µg group) , I wouldn't be surprised if they go with a dose closer to 10µg.




Note they indicate a Phase IIb/III trial is scheduled. This could allow them to test combinations of the four as well under the IIb portion if they believe it could provide greater efficacy at a lower side-effect risk.

Bill Gates has also been funding the manufacturing scale up and validation of 16 different vaccines (not sure if this is one of them) to help the vaccine come to market faster. I can't understate how much "pre-loading" this part of the process will reduce time to market. Scale-up, equipment validation, process validation, etc. all take a significant amount of time and are critical to ensuring the manufacturing process is safe. By doing it now you are cutting multiple months off of the time it takes to produce the vaccine(s).

I came back to update with more info since I didn't have time earlier. No need. Great summary, Pedro.

[CitizenBBN]

Like the others, I'll take good news on this, b/c frankly this year has sucked pretty hard so far for everyone. Would be nice for at least the virus crap to finally go away. I know it won't, but at least become not a driving force of our existence would be OK.

At least until the Chinese come up with the next damned virus. They're on a roll so far, with this one really being the crown jewel in their efforts to drive us to a dystopian Walking Dead style apocalypse. They've tried pigs, birds and bats. Maybe a nice Guinea Pig virus is next.

[dan_bgblue]

https://www.sciencedaily.com/releases/2020/07/200702144054.htm

https://www.sciencedaily.com/releases/2020/06/200630125129.htm

[MickintheHam]

I hope It is also good news for my investment in Pfizer. That damn stock needs good news.

[dan_bgblue]

[QUOTE=MickintheHam;644194]I hope It is also good news for my investment in Pfizer. That damn stock needs good news.[/QUOT

Nice bump so far today (https://www.foxbusiness.com/markets/us-stocks-july-13-2020)

[dan_bgblue]

Some more Vaccine News (https://www.sciencedaily.com/releases/2020/07/200714171338.htm)

[Bakert]

Although it doesn't provide a lot of detail, here is a decent "vaccine tracker:"

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html