Moderna Vaccine information released.

[GeoffH]

https://www.fda.gov/media/144434/download?fbclid=IwAR1e6uQKUbtU1VJ1IUAsAZKC_KQg3CU0NpHcpHNZnw13_kGCsu22Y7-faBo

*cliff notes version from YLE* (but basically it's a toss up between this and Pfizer)

In short, things are looking really good. And, not surprisingly, data are very similar to Pfizer’s data. This is because the Moderna vaccine is using the same biotechnology (mRNA) as Pfizer.

Number of Participants

-A total of 30,350 people had 2 months of follow-up data and were included in this report (15,184 in the vaccine group and 15,165 in the placebo group)

-Only adults aged 18 years and older were included (this is different than Pfizer)

Efficacy

- 94.1% overall. For those 65+ years, 86.4% efficacy

- After first dose, the vaccine is 80% effective

- All severe cases of COVID19 (which was 30 people) were all in the placebo group

- Effectiveness did not differ by chronic conditions, including obesity

-This report hints, for the first time, that the vaccine may prevent asymptomatic infections after the first dose. 38 people in the placebo and 14 in the vaccine group had asymptomatic infection. This is a very important piece of new information, but we need much more data. This is only one small piece of the puzzle regarding sterilizing immunity

Safety

-The most common solicited adverse reactions (i.e side effects we were expecting) were injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%), and chills (43.4%); 0.2% to 9.7% were reported as severe, with severe solicited adverse reactions being more frequent after dose 2 than after dose 1

-Fever was reported after any dose by 14.8% of vaccine participant and 0.6% of placebo recipients. Fever was much more common after Dose 2

-There was a higher rate of hypersensitivity events among vaccine recipients than those who received placebo. There were no anaphylactic or severe hypersensitivity reactions related to the vaccine

-Serious adverse events, while uncommon (1% in both groups), represented medical events that occur in the general population at similar frequency as observed in the study. Of the 7 severe adverse events in the vaccine group, FDA considered 3 as related to the vaccine: nausea and vomiting (n=1) and facial swelling (n=2).

-Swollen lymph nodes (lymphadenopathy) was reported in 1.1% of vaccine recipients (173 people) compared to 0.63% of placebo recipients (95 people)

-There was a small imbalance in the number of participants reporting Bell’s palsy (3 people in the vaccine group compared to 1 person in the placebo group)

-Pregnant people were not eligible for the study. However, 13 people did get pregnant during the trial (6 vaccine, 7 placebo). One spontaneous abortion and one elected abortion occurred both in the placebo group.

-13 deaths were reported (6 vaccine, 7 placebo). Mostly heart issues again (which is the number one killer in the US, so this is no surprise)

-There are no specific safety concerns identified by age, race, ethnicity, medical comorbidities, or prior COVID19 infection

[KC813]

Thanks for sharing!  If there was an upside to this pandemic, it was observing what can be achieved when vast resources and attention are focused on a single biological issue.  Thousands of small research pieces over nine months – when combined into a single picture – have greatly advanced science’s knowledge of all phases of a SARS virus infection.

Of course, there are still questions to be answered on the long-term effects of using any mRNA vaccine, but those potential consequences are seeming less and less likely.  No doubt studies will continue on this.

The mRNA vaccines are fragile and must be kept under close temperature control from production to injection.  Personally, I have reached a point where I would feel comfortable getting either Pfizer’s or Moderna’s mRNA vaccine.  But I’m stuck here in the States, where I have ‘reasonable’ confidence that the product was handled properly. 

 

In PH, I think I might be a little less confident that someone in a clinic somewhere would actually take responsibility for destroying a batch of vaccine if temperature protocols were accidentally breached.

Anyway, it is looking more and more likely that the main vaccines in the Philippines will be China’s inactivated virus-type or Russia’s weakened virus vaccines.  Both much more stable and easier to transport.

We are getting closer to seeing an end, but still some time before I can trash my masks.  Yet, I’m optimistically looking at airfares for April-May!

 

[Jack D]

From what I understand, the Moderna vaccine has fewer unwanted side effects then the Pfizer version.

Plus, I’ve learned that most seniors (which includes me) have fewer side effects with either of the vaccines than  the rest of the population.

So, I’m taking back my earlier statements about not taking a vaccine for COVID-19.

[GeoffH]

A while ago I said something like "I don't have a horse in this race but if I did it would be Astra-Zeneca".

That was mainly because it uses well understood and established technology and any side effects were very likely to be similar to other vaccines using the same technology (ie to say it was in my mind less risky). 

But I'm coming around to think that the new mRNA vaccines (with their almost astounding efficacy) are what I'd choose if I had a choice assuming like Jack D says that it was being given in America (or another first world country).  Like him I have doubts about distribution of mRNA vaccines in third world countries and the cold chain breaking down.

I suspect however that at least in the early stages Astra Zenecas available stocks will be much greater than the other western vaccines and we might even see government using more limited stocks of higher efficacy vaccines for groups at higher risk in some places (and yes I'm talking about first world countries here).

In the Philippines I suspect it'll be a choice between one of the Chinese vaccines as the only options for a while.

Edited December 17, 2020 by GeoffH

[Freebie]

1 hour ago, GeoffH said:

A while ago I said something like "I don't have a horse in this race but if I did it would be Astra-Zeneca".

That was mainly because it uses well understood and established technology and any side effects were very likely to be similar to other vaccines using the same technology (ie to say it was in my mind less risky). 

But I'm coming around to think that the new mRNA vaccines (with their almost astounding efficay) are what I'd choose if I had a choice assuming like Jack D says that it was being given in America (or another first world country).  Like him I have doubts about distribution of mRNA vaccines in third world countries and the cold chain breaking down.

I suspect however that at least in the early stages Astra Zenecas available stocks will be much greater than the other western vaccines and we might even see government using more limited stocks of higher efficacy vaccines for groups at higher risk in some places (and yes I'm talking about first world countries here).

In the Philippines I suspect it'll be a choice between one of the Chinese vaccines as the only options for a while.

For those willing to pay , I would thinki that there will be a few choices , especially due to serious mistrust of the Chinese from the monied classes.

Can you see Jaime Augusto Zobel de Ayala or Manny Pangilinan saying " Sure give me the chinese one "

There will be medical facilitates with more international brands available.

I wonder if medical insurance policies give refunds for vaccine. I need to ask the good people at Cigna....

[Jack D]

Hospitals Discover a Surprise in Their Vaccine Deliveries: Extra Doses

Pharmacists have found that they can squeeze an additional dose from some of the glass vials that were supposed to contain five doses of the Pfizer vaccine.

As boxes of Pfizer vaccines began arriving around the country this week, hospital pharmacists made a surprising discovery: Some of the glass vials that are supposed to hold five doses contained enough for a sixth — or even a seventh — person.

The news prompted a flurry of excited exchanges on Twitter and pharmacy message boards this week as hospital workers considered the tantalizing possibility that the limited supply of desperately needed vaccine might be stretched to reach more people.

But it also set off a wave of confusion and debate over whether to use the extra doses, or to throw them out. At Northwell Health in New York, for example, an executive estimated that the hospital network might have thrown out enough extra vaccine to account for 15 to 20 doses while it waited for guidance from the state health department.

On Wednesday, the pharmacists got an answer. In a statement, the Food and Drug Administration said that, “given the public health emergency,” it was acceptable to use every full dose left over in each vial. The agency said it was consulting with Pfizer to determine “the best path forward” and advised health officials not to pool doses from multiple vials.

We never want to waste — waste medication, waste vaccine,” said Anna Legreid Dopp, senior director of clinical guidelines and quality improvement at the American Society of Health-System Pharmacists. “So that would be exciting if that is an opportunity.”

The vaccine, which was developed by Pfizer and the German company BioNTech, is in extremely short supply. Pfizer has said it has manufactured enough vaccine to supply at least 25 million doses — enough for 12.5 million people since it requires two shots — to the United States before the end of the year, but federal officials have allocated it carefully, doling out only 2.9 million doses beginning this week after the F.D.A. authorized its emergency use last Friday.

Because the vaccine is so scarce, it is being given first to frontline health care workers and residents and staff in nursing homes, and experts have said a vaccine won’t be available for every American who wants one until well into next year.

In a statement, Pfizer said there is a uniform amount of vaccine in every vial, but that the amount left over after five doses are removed could vary based on the type of syringes and needles as well as the amount of diluting solution used. The company said it was consulting with the F.D.A. about the issue and could not “provide a recommendation on the use of the remaining amount of vaccine from each vial.” It advised staff members doing the vaccinations to consult with local institutions.

 

https://www.nytimes.com/2020/12/16/health/Covid-Pfizer-vaccine-extra-doses.amp.html

[Snowy79]

How to instil confidence if after spending probably hundreds if not thousands of millions developing a vaccine they can't even get the measurements accurate.  I'll wait until the vaccine is available at my local car boot sale. 

[Dave Hounddriver]

1 hour ago, Jack D said:

as well as the amount of diluting solution used.

That is from the article you quoted.  Reminds me of my old dealing days.  How much can you dilute the product and still keep the buyer happy and paying the same price.  Hmmm.

[KC813]

7 hours ago, Dave Hounddriver said:

That is from the article you quoted.  Reminds me of my old dealing days.  How much can you dilute the product and still keep the buyer happy and paying the same price.  Hmmm.

Dave- Perhaps in your younger 'dealing' days, as I also seem to recall, the products didn't come with written instructions!

I didn't know that some vaccines have to be diluted in their vial before use. The inoculation process is not as simple as I envisioned.  I pulled the below instructions off the internet, from the US military standing order.  I could of asked my RN wife, but that conversation usually gets sidetracked to a lecture on my various vices .

 

The multidose vial may be stored frozen at -80°C and must thaw prior to dilution
• Frozen vials should be transferred to 2°C-8°C to thaw; alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 25 °C for immediate use.
• Once thawed, the undiluted vaccine can be stored for up to 5 days at 2°C-8°C and up to 2 hours at 25°C.
• Diluted vaccine must be used within 6 hours from the time of dilution and stored between 2°Cand 25°C.
• Dilute the multidose vials according to the following directions:
o Allow the thawed vial to come to room temperature and gently invert 10 times prior to dilution; do not shake.
o The thawed vaccine must be diluted in its original vial with 1.8 mL of preservative-free sodium chloride (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic technique.
o Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
o Gently invert the diluted solution 10 times; do not shake.
o The diluted vials should be marked with the dilution date and time and stored between 2°C to 25°C.

[Mike J]

8 hours ago, KC813 said:

Dave- Perhaps in your younger 'dealing' days, as I also seem to recall, the products didn't come with written instructions!

I didn't know that some vaccines have to be diluted in their vial before use. The inoculation process is not as simple as I envisioned.  I pulled the below instructions off the internet, from the US military standing order.  I could of asked my RN wife, but that conversation usually gets sidetracked to a lecture on my various vices .

 

The multidose vial may be stored frozen at -80°C and must thaw prior to dilution
• Frozen vials should be transferred to 2°C-8°C to thaw; alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 25 °C for immediate use.
• Once thawed, the undiluted vaccine can be stored for up to 5 days at 2°C-8°C and up to 2 hours at 25°C.
• Diluted vaccine must be used within 6 hours from the time of dilution and stored between 2°Cand 25°C.
• Dilute the multidose vials according to the following directions:
o Allow the thawed vial to come to room temperature and gently invert 10 times prior to dilution; do not shake.
o The thawed vaccine must be diluted in its original vial with 1.8 mL of preservative-free sodium chloride (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic technique.
o Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
o Gently invert the diluted solution 10 times; do not shake.
o The diluted vials should be marked with the dilution date and time and stored between 2°C to 25°C.

So the party responsible for giving the shots does the diluting in a multiple dose bottle. There will always have to be some extra liquid vaccine left because you cannot allow air into the syringe prior to giving the shot.  You always "shoot" just a it from the filled syringe  after filling to remove any air.  Also there remains some vaccine in the bottom of the vial so the tip of needle remains under the surface while drawing in liquid.  So where multiple shots arrive in a single vial it is not surprising that there would be enough left for at least one shot.  I give my dog their shots for rabies, parvo, distemper, etc.  The rabies comes in two vials one with the "dry stuff" and one with the liquid.  There is always about 1/3 of the liquid left so not at all surprising there would be enough vaccine left for an extra shot.   Also gave myself weekly injections for 30 months to dampen my allergies so I have a bit of experience.