COVID vaccine update

[NJwave]

Well, one of my predictions just came true; Johnson and johnson has announced that they have submitted an emergency use application to the FDA for their vaccine. The FDA will have their people go through the data, do the calculations themselves, review the side effects and then decide on approval. Unless there is something nefarious in the data I would expect it to be approved in the next 2-3 weeks.

This vaccine is one dose, which will make it more palatable to a lot of needle-phobic people. Its effectiveness is not as good as the Moderna and Pfizer, but if you look at the effectiveness of a single dose, it actually does better (which is why Pfizer and Moderna use a "two dose" protocol to reach the 95% effectiveness).

In the cases of people who get the infection despite getting the J and J vaccine, it is entirely possible they have a milder case than they would have had without the vaccine. Since J and J have done this, Astra-Zeneca will either "fish or cut bait." Unless there is some problem with their vaccine, expect its application to be dropped in the next week or two.

Is it true that J&J has a two dose trial going on as well? With their distribution capabilities and the fact that vaccine does not to be stored at such cold temparatures, I would think if having second dose would get close to the same efficacy as Moderna and Pfizer it would truly be a game changer.

[AO Sig]

I will ask my sources at J and J (their division Janssen makes 4 medications that are used a lot in my specialty- two are being downplayed because they have better choices now) about the 2 dose regimen. I would think that they have one going on, particularly in view of the fact that the first two to come out first had much better protection with two, and that both the Moderna and Pfizer reached only a 50% or so with one dose. In these studies they usually have multiple dosing arms in their studies to set the dose and frequency of treatment. That is why enbrel is given weekly, but Humira has an every 2 week treatment schedule. I have wondered the same thing, to be honest.

[windywave]

Well, one of my predictions just came true; Johnson and johnson has announced that they have submitted an emergency use application to the FDA for their vaccine. The FDA will have their people go through the data, do the calculations themselves, review the side effects and then decide on approval. Unless there is something nefarious in the data I would expect it to be approved in the next 2-3 weeks.

This vaccine is one dose, which will make it more palatable to a lot of needle-phobic people. Its effectiveness is not as good as the Moderna and Pfizer, but if you look at the effectiveness of a single dose, it actually does better (which is why Pfizer and Moderna use a "two dose" protocol to reach the 95% effectiveness).

In the cases of people who get the infection despite getting the J and J vaccine, it is entirely possible they have a milder case than they would have had without the vaccine. Since J and J have done this, Astra-Zeneca will either "fish or cut bait." Unless there is some problem with their vaccine, expect its application to be dropped in the next week or two.

Is it true that J&J has a two dose trial going on as well? With their distribution capabilities and the fact that vaccine does not to be stored at such cold temparatures, I would think if having second dose would get close to the same efficacy as Moderna and Pfizer it would truly be a game changer.

They do. Results May June IIRC.

You can't compare the efficacy of the JNJ and mRNA vaccines because of the way the studies were conducted. Brass tacks they are probably pretty close already

[AO Sig]

A quick blurb I saw; South Africa appears to have stopped use of the Astra-Zeneca vaccine because it does not seem to be very helpful against the South African strain of COVID. The J and J has lower response against that strain than the other strains, which is why the response levels to that vaccine have been a bit lower in general.

The problem with the mutations in the strains might result in people getting annual shots similar to the flu shot, where the vaccine is modified to combat the prevalent strains. The guy I spoke with at pfizer says that the new technology lets them change the mRNA substrate quickly, so they can modify their vaccine rather quickly as well.

[PeteRasche]

BTW, not that this means anything one way or the other, but I know of someone who received the first of two vaccine shots (either Moderna or Pfizer, not sure which) and contracted COVID in the time before receiving the second shot. It might be possible that it helped lessen the effects (flu-like symptoms were all she experienced) but how would anyone know what they would have been without the first vaccine shot, so who knows...

[tulaneoutlaw]

BTW, not that this means anything one way or the other, but I know of someone who received the first of two vaccine shots (either Moderna or Pfizer, not sure which) and contracted COVID in the time before receiving the second shot. It might be possible that it helped lessen the effects (flu-like symptoms were all she experienced) but how would anyone know what they would have been without the first vaccine shot, so who knows...

This has happened to someone in my circle as well. They had very mild symptoms but is it because they had one shot or would they not have seen symptoms anyway? Hard to say, but they are very thankful to have gotten the first shot anyway. Seems like there was a politician (maybe state-level in Mass.?) that had both shots and still contracted Covid, but had no visible symptoms. At some point there may be enough cases like these that phrama companies can can reasonably say even if you catch Covid after the shots, your symptoms are likely to be extremely mild.

[wavedom]

I don't believe they have ever claimed the vaccinations prevent you from getting infected. It's intent is to keep you from getting the symptoms. It's why they want people who got vaccinated to continue to wear a mask because they don't know yet if they could infect others if they did get infected.

[PeteRasche]

I don't believe they have ever claimed the vaccinations prevent you from getting infected. It's intent is to keep you from getting the symptoms. It's why they want people who got vaccinated to continue to wear a mask because they don't know yet if they could infect others if they did get infected.

Technically, no vaccine really prevents you from catching it, right? Just strengthens your immune system such that it doesn't bother you and your immune system kills it off, right?

So, yeah, I guess I should say the person I know caught it and "exhibited symptoms" despite having had the first shot.

[noladave]

had my 2nd shot at lunch today, and no adverse reactions so far. had minor reaction after 1st shot. Since I was lucky enough to get the shots, hopefully will be able to travel to the away games that allow fans. sure would be nice.

[Private Joker]

BTW, not that this means anything one way or the other, but I know of someone who received the first of two vaccine shots (either Moderna or Pfizer, not sure which) and contracted COVID in the time before receiving the second shot. It might be possible that it helped lessen the effects (flu-like symptoms were all she experienced) but how would anyone know what they would have been without the first vaccine shot, so who knows...

This has happened to someone in my circle as well. They had very mild symptoms but is it because they had one shot or would they not have seen symptoms anyway? Hard to say, but they are very thankful to have gotten the first shot anyway. Seems like there was a politician (maybe state-level in Mass.?) that had both shots and still contracted Covid, but had no visible symptoms. At some point there may be enough cases like these that phrama companies can can reasonably say even if you catch Covid after the shots, your symptoms are likely to be extremely mild.

This happened to my cousin.

[AO Sig]

I forgot to mention that an article just reported that some inflammatory proteins are found in the cerebrospinal fluid of patients with COVID, might be the reason for the 'brain fog" that COVID patients get. Might respond to various anti-inflammatory agents; they mention steroids, not sure if the NSAID's help.

[AO Sig]

Well, I had a chance to chat with a medical science liaison from Janssen/ Johnson and Johnson about their new vaccine. To start off with the "wonky" stuff, it is a modified adenovirus (these are fairly common viruses, cause respiratory and GI symptoms, usually not too bad) which has been modified with the spike DNA. Because of my specialty I asked about the virulence (people who have immunocompromise due to disease or medicines can be at an increased risk of some pathogens); she tells me that it is so "weak" that it is not considered "live" because of experience with a similar use for RSV (respiratory syncytial virus)vaccine, and it only is in the body for a few days, just enough to trigger immunity. The data they have on the patients like mine are based on cancer patients allowed in the studies.

They do have at least 2 "2 dose vs 1 and done" studies; one has a six week separation between 1st and 2nd dose, which is one reason it is taking longer. It is shipped frozen, but it can be kept in a refrigerator. Once brought to room temperature it needs to be used in about 6 hours; once thawed it cannot be frozen again.

One nice thing is that in addition to triggering the "antibodies" she said it also generates a very robust "cellular," or T-cell response. One nice thing about it is that when their experience with similar vaccines looked at duration, they saw at least 2 years' worth. The only problem will be if the virus mutates; she did say that they can modify the vaccine reasonably quickly, but cannot anticipate the changes in the virus the way we can sort-of anticipate which influenza strain will show up each year. I asked if they have been able to correlate degree of side effects to how effective, or if the vaccine will reduce disease severity; both of those are being looked at.

These are the big take-aways I got from the chat; an interesting turn of events was that she called me from an area code with which I was very familiar, so we had to discuss our king cake experiences, etc.

[wavedom]

Thanks again for all of your updates on the information.

[Cheerleader]

I got my second Moderna shot last Wednesday. I had no side effects for first 24 hours, then a nagging headache and maybe a little fever and a general run-down feeling. It all went away in another 24 hours and now I feel fine. My wife had a similar reaction, but her symptoms were a sore arm and aching joints. I didn't have either of those.

[AO Sig]

If you want to have some fun with people, tell them you had no problems other than uncontrollable flatulence for about a week. I mentioned this to the Pfizer scientific officer; he broke out laughing, told me that he had to report that to the FDA. I quickly told him not to bother...

My mother in law and brother in law (he is a dermatologist in Tuscaloosa) have decided to wait until the J and J vaccine becomes available. Personally, my thinking is that once it is approved and released, it will be a real game changer in terms of seeing a big jump in numbers getting vaccinated.

[TUPF]

I am not sure why but I received an appointment for Saturday morning at a Philadelphia hospital clinic. My only guess is that my medical history was flagged when I signed on the waiting list since otherwise I am under 65 and am not public facing. I'll take it. I won't know if it will be Moderna or Pfizer until I arrive.

[TU77CAL82]

I am not sure why but I received an appointment for Saturday morning at a Philadelphia hospital clinic. My only guess is that my medical history was flagged when I signed on the waiting list since otherwise I am under 65 and am not public facing. I'll take it. I won't know if it will be Moderna or Pfizer until I arrive.

My healthy son-in-law up in Sullivan County, PA was able to get the vaccine at age 41. All I could figure was that the county's allotment of vaccine exceeded the number of old people willing to get it.

[TUPF]

I am not sure why but I received an appointment for Saturday morning at a Philadelphia hospital clinic. My only guess is that my medical history was flagged when I signed on the waiting list since otherwise I am under 65 and am not public facing. I'll take it. I won't know if it will be Moderna or Pfizer until I arrive.

Received Pfizer #1 this morning. I asked why I was bumped up in the line and the PA said it was because of my history of anaphylaxis, so at least it was with forethought and not just luck. They kept me for 45 minutes whereas others were released after 15. I felt a little flush a few minutes after the shot but it quickly dissipated. No arm soreness. #2 in 3 weeks.

[WaveProf]

Congrats TUPF!

My wife got the second dose of Pfizer on Wednesday. Felt a LITTLE run down during the day Thursday, but fine by evening. And more or less no arm soreness. Even less than the first shot.

My mother gets the second dose of Moderna on Thursday, will report back.

I'm a ways off, in spite of a huge lobbying push (Mostly funded by Tulane) to not differentiate between K-12 teachers and college professors, the state changed their mind at the last minute and differentiated, making the next wave only K-12 and preschool. The argument being that K-12 students don't socially distance from the teachers as well as higher ed. True, but most K-12 don't spend their weekends at The Boot and Tigerland

[TUPF]

Thanks, Prof. Pennsylvania and Philadelphia in particular have been middle of the pack or lower in the vaccine derby so I feel lucky. My experience today was clockwork and very professional but then it was a full blown medical facility and not just a CVS or Walgreens. I'm particularly impressed by New Mexico where lots of my extended family live and have all been vaccinated. They seem to have had their stuff in one bag along with West Virginia since the beginning.

[AO Sig]

i am here visiting my daughter (her 21st bday was Thursday) in Orlando; Florida is planning to open 4 big "Federal vaccination centers," one of which is here in Orlando. My suspicion is that they are doing this in anticipation of the Janssen vaccine getting approved in the next 1-2 weeks. The other three are located in Miami, Jacksonville and Tampa.

[windywave]

i am here visiting my daughter (her 21st bday was Thursday) in Orlando; Florida is planning to open 4 big "Federal vaccination centers," one of which is here in Orlando. My suspicion is that they are doing this in anticipation of the Janssen vaccine getting approved in the next 1-2 weeks. The other three are located in Miami, Jacksonville and Tampa.

Too bad J&J only has a few million doses ready

[AO Sig]

In case you did not see it in the news, the FDA scientific staff have confirmed that the Janssen/J and J vaccine is effective. the data now goes through a panel, and I would expect the vaccine to be approved by the end of the weekend. My contact at that company implied to me that they can ramp up production fairly quickly, and the number of available doses of the three vaccines should increase the number of people vaccinated rapidly.

one quick study from the CDC I just read suggested that there might be a better immunologic response if the interval between the two doses is a bit longer; since I got my two doses just under 3 weeks apart, I hope that this is not all that significant. A couple of my staff have had their antibody levels checked a month or so after getting the two doses of the Pfizer vaccine; both had shorter than 3 weeks intervals, and both had fairly good antibody levels. One had antibody levels that were three times those seen in someone we know who actually had the COVID infection and recovered without incident. Makes me feel a bit better about the vaccines and their effectiveness.

[wavedom]

Good to hear. Thanks again for these updates,

[TUPF]

AO Sig, about antibodies. Would really like to hear any definitive research about antibodies after having been symptomatic.

In one case family members, one of whom falls squarely in the anti-vax camp, had a bad time with COVID including the husband spending Christmas Eve in the ER. They now think they are bulletproof and as recently as last week flew to a ski holiday out of state.

In another case my best friend from Tulane spent 3 weeks down hard with COVID with two ER visits and finally tested negative on the PCR test yesterday. His doctor has advised him to seek vaccination in the June timeframe and says the antibodies he gained the hard way will hold him that long. He is keen to do so.

My read is that having had COVID and survived gives one some hard earned antibodies but is by no means a golden ticket nor is it permanent but guidance seems to be scattered. Any updates?