Jump to content

zanderblue

Members
  • Content Count

    193
  • Joined

Posts posted by zanderblue

  1. Update on Novavax trial in Scotland.

     

    I attended clinic today in Aberdeen Royal infirmary, and entered “crossover” phase of the trial.

    New study protocol to read and sign, followed by BP, temperature and O2 checks, then throat and nasal swabs (urgh!), then blood sample for antibody tests and finally an injection.
    I’m still blinded, but I now know for certain I’ve had at least one vaccine shot. Today or last October, but who cares?

    Back in three weeks for second injection.

    I did ask today about how these injections are being recorded and had it confirmed that all details are being passed to my GP for him to include in my personal medical records. I will also be given a certificate of vaccination after my visit in 3 weeks time.

    7 hours on after injection and I am beginning to develop a slight headache.........
     

  2. 11 hours ago, helen haywood said:


    We had this same agent.  Has anyone ever heard how he was/is doing?


    I did ask about him to the new TA that took over our bookings. They were very tight lipped and would only say that the incident was not fatal, but that it was unlikely he would be back at work. 

  3. Like Bo1953, we had a very similar issue. TA was a one man show, who up until time of his disappearance had offered a very good service. We eventually found out that he had a very serious medical emergency and was no longer able to service his clients.

    You need to talk to Celebrity customer services as soon as you can, chances are they are already aware there is an issue. 
    They have procedures to deal with this type of problem. In our case, our existing bookings were transferred to another TA of Celebrity’s choice. It all worked out well in the end.

  4. 16 hours ago, TeeRick said:

    Very interesting strategy! I am trying to find information on this as the original trial protocol has perhaps been amended to account for the other successful vaccines now available.  Here is a story from a current Novavax trial participant and his choices going forward.  It does mention something about an amended study with a blinded crossover:

     

    "Another option would be to stay in the study and, at some point, get the real Novavax vaccine. The company has amended the study protocol to incorporate a blinded crossover system. While details aren't immediately available, that means I'll be given the opposite of what I'm getting now at some point: If I'm currently getting the placebo, I'll be switched to the experimental vaccine."

     

    https://www.medpagetoday.com/infectiousdisease/covid19/91144

    @TeeRick not the Novavax trial protocol per se, but see below an extract from an email I received from doctor managing trial at the hub I attend.

     

    ”Thank you for getting in touch with us about your NHS appointment. I will try and give you a call tomorrow - apologies as we have received a very high volume of calls.

     
    In the meantime I wanted to explain that there are two options going forward.
     
    Following the news of Novavax's vaccine efficacy of 89.3%, Novavax is on the way to change to format of this trial. This will involve all our participants getting the Novavax vaccine. How this will work is that everyone will get injected with two courses of placebo or vaccine; the opposite of what they received the first-time round. This will mean that everyone will be ensured a vaccine without breaking the blind of the original injection.
     
    If you decide to wait for the Novavax vaccine, this will require that you wait for this change to implemented, and this will occur end of March / beginning of April until approval is received by the governing body. The advantage is that unlike the NHS schedule, you can receive both shots within 3-4 weeks as opposed to waiting 12 weeks for your second injection.
     
    If you would prefer to get vaccinated sooner, we would ideally arrange an unblinding visit 1-2 days before to take a blood sample before we unblind you. This would be a short visit and once done, your original fourth visit can be skipped. After that, we would keep you in the trial unblinded and continue the antibody tests. (The visit only applies if you have not already attended a fourth visit.)
     
    Once you have considered the options, let us know what you decide, and we can make a plan going forward. Feel free to get in touch again if you have any other questions.”
     
    The doctor did call me the following day and discussed more detail. The dates provided are expected to be improved upon, and are subject to vaccine receiving timely approval. 
    I have decided to forego my NHS vaccination this week and stay blinded in the trial, at least for now. Very much a watching brief though...........
  5. Novavax phase 3 trial here in Scotland is being modified. They are now changing to what they are calling “crossover” phase. Basically, they are offering Novavax vaccine to all those in the trial who were originally given the placebo. The vaccine will be given in 2 doses, 3 weeks apart assuming it is approved by the regulator (probably late March)

    I only found out about this when I talked to trial team earlier this morning to discuss being unblinded since I have been called to get my first NHS vaccine shot. 
     

  6. I have attached link below to the current COVID vaccination plan for Scotland. Headline details are on pages 8 and 9, but also interesting to note that the plan is based on worst case for vaccine availability. Let’s hope that it they can deliver it.

     

    https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2020/12/coronavirus-covid-19-vaccine-deployment-plan-2021/documents/coronavirus-covid-19-vaccine-deployment-plan-2021/coronavirus-covid-19-vaccine-deployment-plan-2021/govscot%3Adocument/COVID-19%2Bvaccine%2Bdeployment%2Bplan%2B14%2BJanuary%2B2021.pdf

     

     

  7. 1 hour ago, edgee said:

    Thanks. What is your situation in terms of when you can become unblinded? My concern boils down to (1)whether the researchers (for absolute certain) will unblind me when vaccine through regular channels become available, and (2) if it turns out I did get the real vaccine (2 thirds chance I will), will I be able to get proper documentation that I am vaccinated in case a cruise line or foreign country demands proof of vaccination.

    I am in the Novavax phase 3 trial in Scotland; started in November.

    I have had both injections, don’t know if placebo or vaccine. I have had it confirmed that when I am called for approved vaccine, they will unblind me.

    If I have had placebo I should go ahead and have the approved vaccine, if I have had the vaccine I have been told that they do not recommend I have the approved vaccine. The reason they give for this is that they have no evidence of how the two vaccines may react. 

    They also indicated that anyone who has only had a single injection of the Novavax vaccine should go ahead and have the approved one. As far as I know everyone in the Phase 3 trial here should have had the second injection before Christmas.

  8. On 12/17/2020 at 3:28 PM, frankdp said:

    X is still showing multiple cruises on their website on Connie out of Tampa that are 10 and 11 nights beginning in March.   I chatted with a very nice lady (using the chat feature) and she told me that these cruises were still scheduled to sail as listed.   We all know that at least, these cruises will be shortened to 7 nights as mandated and with all of the uncertainty surrounding the Constellation, these cruises will possibly not sail at all.

     

    If they really intend to bring Connie to Tampa and begin sailing in March, why wouldn't they reset those cruises on the website to reflect the actual 7 day itinerary?  

     

     

     

     

     

    I don’t know for certain, but I’d hazard a guess that right now Celebrity don’t know with any certainty which ships will sail where or when.

    Their near and medium term schedule is in tatters and there has been nothing but cancellations followed by rescheduling as the pandemic has rolled on.

    I’m not a Celebrity apologist, but I think we all need to acknowledge that whatever they do they are going to struggle to get much right.

    I do note that they have tried to get out in front of things with their W21/S22 redeployment plans. But even with that they are struggling to work through the changes.

  9. 15 hours ago, phoenix_dream said:

    I sincerely applaud and appreciate those who took the risk to sign up for the vaccine trials.  The following questions may make you think otherwise, but I truly do.  But I guess I need to ask the question - when you signed up, were you advised that if a vaccine became available you might still need to wait as a trial participant, even if you got the placebo?  If they didn't so advise you, then shame on them.  If that was part of what you agreed to, then I guess I don't understand why you would be bitter?  And I guess even if you do need to wait until your 6 month mark, I am presuming that means 6 months after you got your shot?  That would likely mean you would be allowed to get your vaccine around the same time all the rest of us will, or in fact maybe even a month or two before us?  

     

    I am in the Novavax trial.

    I was told prior to entering the trial, that if an approved vaccine became available, then I could drop out of the trial and take it.

    At my third appointment a few weeks ago we discussed situation again and I was told that when I was called for an approved vaccination I should call and they would unblind me. At that time, if in placebo arm I should go ahead and be vaccinated, if in vaccine arm, then they would do antibody tests then advise.

    Very recently I received written advice to the effect that if I was in trial vaccine arm and had received both doses (which I have), then at this time they advise that I do not take the approved vaccine.

    I am okay with all of this, but I will say that the level of detail they are providing now would have been useful to have at the start. Not that this would have changed my decision to participate.

    They have stated that all participants who are in the placebo arm would be given the vaccine at the end of the trial if it had been approved by then.

     

  10. 14 hours ago, PTC DAWG said:

    Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…

     

    Today the FDA released Pfizer’s Phase III vaccine trial data. This is big, as this is the first time we, scientists, have seen the data. Pfizer’s report was 92 pages long and the FDA report was 53 pages long. And, yes, I read it all. Here are your cliff notes…
    Things are looking good. Well, not just good, they are looking great. This trial was as clean as it can get. There is nothing (big) we didn't expect.
    Efficacy.
    • We see benefit starting 14 days after the first dose (see Figure). This makes sense because it takes about 2 weeks for the immune system to make sufficient antibody protection after vaccination.
    • After the first dose, efficacy was 52%. This is a fantastic for a single dose.
    • After your second dose (3 weeks later), efficacy is 95%. We are confident that efficacy ranges from 90-98%.
    • Efficacy doesn’t meaningfully differ by age, race/ethnicity, or comorbidity.
    Adverse events.
    • Overall, the Pfizer vaccination gives more adverse events than the flu vaccination but less than the shingles vaccine.
    • The most common solicited adverse reaction (i.e. what we were expecting) were mild to moderate: injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%)
    • The chance of getting a serious adverse event was low (<0.5%). A severe event is more likely in the second dose than the first and were less frequent among older adults compared to younger participants.
    • An unsolicited (i.e. not expected) adverse event that came up more in the vaccine group was swollen lymph nodes (lymphadenopathy). 64 people in the vaccine group compared to 6 people in the placebo group. This could be related to the vaccine.
    • There were 4 people in the vaccine group that got Bell’s palsy (compared to 0 in the placebo group). These cases occurred at 3,
    9, 37, and 48 days after vaccination. This isn’t much of a concern because it reflects the same rate of Bell’s palsy in the general population. Something to keep an eye on
    • 6 people died during the trial (4 in placebo; 2 in vaccine group). Deaths were NOT related to the vaccine. Mostly related to heart attacks.
    There are a few unknowns. From this study, we do not know…
    • Duration of protection
    • Effectiveness against transmission
    • Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals. There were just not enough people in the study to make meaningful conclusions. This likely means that the FDA will not approve emergency use for these populations. We will know more on Thursday.
    • Benefits of individuals with prior COVID19 infection. But, given there is documented reinfection, the FDA stated that previously infected people could benefit from vaccination.
    Translation: This vaccine will likely be approved on Thursday. Which, by the way, will be streaming live. An event that will likely go down in history, albeit a bit boring, scientific, and long.

     

    These seem to be important, but that's just me

    There are a few unknowns. From this study, we do not know…
    • Duration of protection
    • Effectiveness against transmission
    • Effectiveness or safety among certain high-risk populations, such as children less than 16 years of age, pregnant and lactating individuals, and immunocompromised individuals.

     

    https://www.fda.gov/media/144245/download

     

    Thanks for sharing this.

    I found the comment about swollen lymph nodes particularly interesting. I’m am participating in the Novavax phase 3 trial and on all 3 appointments to date the doctor has examined my neck, throat and armpits. I did ask about this at the initial appointment and was told they were checking my lymph nodes. 

    It would appear that this side effect may not be unexpected in the Novavax vaccine??  

  11. @nomad098 I can’t say that I agree with much of your postings. I will say this however.............

    It is a fundamental obligation of a government in a democracy to serve and protect its citizens. When such a government receives advice from its public health medical professionals, it needs to pay heed to that advice. All the information I have read or heard to date is to the effect that the medical advice being offered is that the vaccine is safe and effective and needs to be administered to as much of the adult population as is possible.

    I guess that gets us to how the government implements that advice.

    Personally, I see nothing wrong with the government offering inducements to increase the uptake. I certainly don’t see that as being coercive, but rather as inducive.

    I guess, what I’m trying to say is that the matter is very subjective and what I see as reasonable, then another will see as unreasonable.

    I would also go further and say the any government that disregards the advice from its public health medical professionals is likely to find itself in opposition before too long.

  12. 3 hours ago, nomad098 said:

     

    I can only speak to what the UK Government

    No decision made in the UK whether under 50's without a health condition will get the vaccine, you may be able to purchase a vaccine but not until all at risk groups are vaccinated and doses allocated to COVAX

     

     

     

    And I can only speak to what the Scottish government have said.They have made a decision about under 50’s. Below is a quote straight from their covid website. Additionally, the national clinical director is advising under 50’s may have to wait to early summer, but they are on the list!

     

    “Vaccination for other groups will begin as soon as the supply of vaccine becomes available. The aim is for every adult in Scotland to be offered the vaccination.

    NHS Scotland strongly recommends you get your vaccine as soon as it's offered to you.”

  13. 3 minutes ago, Arizona Wildcat said:

    There are no swab tests during the trial so far?

    Very different here with Moderna.  Visit with swabs every couple weeks.

    Rick - how else could they find those with asymptomatic COVID without regular swab tests.  The protocol for Novavax sounds simply like a generic safety heads up.  Didn't their phase 3 trail start just days ago?

    On first visit I had swab test and antibody test. 

    Phase 3 trial started here In Scotland in October and is due to run for 12 months.

  14. Below is an extract from the email we were sent.........

     

    ”This email is a reminder of what to do if you start to have any of these possible COVID symptoms as described on your ‘emergency card’;

    -        New onset of cough

    -        New onset of shortness of breath

    -        New loss of taste or smell

    -        New fever (38C or above)

    -        New onset of fatigue

    -        New onset of muscle aches or pains

    -        All three of sore throat, congestion and runny nose together

    -        New headache lasting >48 hours

    -        New nausea or vomiting or diarrhoea lasting >48 hours

     

    Please call the trial team on XXXXXXXXXXXX within 24 hours of the onset of any of these symptoms. Calls during office hours are preferable where possible; out with these times you will be connected to the hospital switchboard – please ask for the on-call Novavax vaccine trial doctor.

     

    A study nurse or doctor will then discuss your symptoms and advise if it could be COVID. Please do not self-swab until you have been asked to do so.

     

    Many thanks, hopefully you will remain symptom free.”

  15. 2 minutes ago, TeeRick said:

    How frequent are they doing nose swabs to check for the virus in the Novavax trial?

     

    They are only doing throat and nose swabs at direction of study team. The protocol is that we need to call the team within 24 hours if we have symptoms. (We have been given an extended list of symptoms to be aware of)

    The team will discuss symptoms with us then decide if we need to do swabs. We have 3 test kits at home with us, and have been advised we will need to use on 3 consecutive days if told to use them.

  16. I had my 3rd appointment earlier this week as a participant in the Novavax stage 3 trial.

    Brief medical check of vital signs and a blood sample taken for antibody testing.

    I had a chat with doc regarding being vaccinated with approved vaccine. When I am invited to be vaccinated I need to call the study team and they will drop me from study and advise whether I had placebo or vaccine. If latter, she mentioned having further antibody test before decision being made in how to proceed.

  17. 8 hours ago, ipeeinthepool said:

    A question for anyone that has taken a Covid test.  Has anyone every received written confirmation of your results?  I only received a phone call.  I would think that all of the testing clinics are too busy to provide a written report so I could cruise within the next day or two after the results are back.

     

    I was tested last month at my first appointment for the Novavax vaccine trial. I was notified by email and sms text confirming my result.

  18. 3 hours ago, tert333 said:

    In the past, if a cruise is cancelled, they have allowed the move the cruise to another cruise maintaining the same price as the previous cruise.   Traditionally, they have given options which you can select from,  and if you choose not to select the options provided, then you would get an OBC with the new booking at the prevailing rates. 

     

    I am booked on a March 19 Infinity cruise and it does not look like there is a corresponding Summit Cruise.   I am onhold with my TA, who is trying to get in touch with Celebrity and is onhold with them.

    @tert333we are booked on the same cruise. 

    I had an email from my TA yesterday advising that we would be booked on equivalent Summit cruise, but like you, we can’t see a sailing on Summit for that date.

    appreciate any update or info you may come up with.

  19. 1 hour ago, govanguy said:

    Just received my email this morning. Edge B2B cancelled with an offer of OBC to book a similar cruise on Silhouette at an increased price (prevailing rates). 

    Edge initially was at a premium price and may still be.  

    I`ve given up with the pricing malarky. 

     

    With continuing uncertainty regarding CDC 7 day rules and with regret, I cancelled.

     

    In addition, I have a B2B Transatlantic booked for October 2021 on APEX which is looking more and more unlikely. I`m thinking the 9 DAY Caribbean sector  in 2021 will be cancelled and the Transatlantic eastbound in May  2021also being  cancelled. I also have to consider air transport bookings for this trip and the time it takes to receive a refund from the airline , if I cancel.

    Not good......I quit.

     

    It's looking more and more likely I`ll be moving on to A.I. land based or even a land based tour where I may get more certainty.

     

    Finally, I don't seem to fit the new demographic for a Celebrity cruise....c`est la vie. . After 15 years, we`re moving on. Nice while it lasted.

     

    I feel your pain. I can’t help but think that X have been a bit unfair as to how they have rolled this out and the poor conditions they have imposed on existing customers.

    It does appear that that the redeployment has been implemented under the guise of COVID, but has been done in such a way to maximise income.

    Im pretty sure they will have modelled likely outcomes before implementing this and are prepared to lose customer goodwill to get the optimum business outcome for themselves.

    Such a pity, I think you are correct; it may well be time to move on!

     

  20. I have just received an email from my TA, but it looks like a boilerplate statement from Celebrity, see below.......

     

    “Dear Valued Guest,

    We are reaching out to provide an update on the status of your  2021/22 cruise vacation. As the world continues to work towards a new normal, our primary goal continues to be a healthy return to service for our guests, crew and the communities we visit. While working with the Centers for Disease Control and Prevention (CDC) and other local health and government authorities towards this shared goal, we are evaluating all current itineraries to ensure we offer your clients the best possible vacation experience in each destination. This means some of our sailings will need to be modified. 


    Specific to your  future Celebrity Infinity® sailing, these deployment adjustments will require a change of ship for their Caribbean voyage to the fully revolutionized Celebrity Summit®. We are pleased to advise all departure dates, itineraries and booked stateroom categories will remain exactly the same. No action needs to be taken on your part as our Customer Service Teams are working to automatically move your client's reservation to the Celebrity Summit. Once the process is complete you will receive a refreshed booking invoice via email with your client's new stateroom number. We anticipate it will take us a few weeks to complete all the transactions. Please feel free to log-in to your My Celebrity account within the coming weeks and check out everything the Celebrity Summit has to offer as well as their new stateroom number. 

    If you pre-booked any shore excursions, beverage, internet, specialty dining or other onboard packages, through Celebrity Cruises, these will also automatically be moved over to the Celebrity Summit. Guests with independent shore excursion arrangements should contact their tour operators as soon as possible to advise them of this change. “

     

×
×
  • Create New...