Paper and Threads

Wishing You a Happy and Healthy New Year!  But we are in the middle of a huge surge in Coronavirus Cases and even fully vaccinated and boosted people can develop breakthrough cases.  These people, however are reporting mild symptoms, i.e. like a bad cold, and are rarely being hospitalized with severe disease.  Most of the hospitalized patients are unvaccinated.  Today one of my favorite epidemiologists said that neither cloth nor surgical masks are sufficient to block exposure to the omicron virus and recommended N95 or KN95 masks from this point on. 

I follow the daily infection rates for NY State, City, and Manhattan and we are in the middle of a surge that is worse than any other time during the pandemic.  On Nov 1st the Washington Post Covid Tracker said that NY State had 20 Covid Cases/100,000 people.  The infection rate was 0.7% in Manhattan, 1.0% in NYC, and 2.4% in NY State.  On January 1 the Covid Tracker showed 318 Cases/100,000 population, and the infection rates were 18.6% in Manhattan, 22.7% in NYC, and 23.4% in NY State.  When I take my early morning walk lines are very long for testing at multiple sites in my area.  For high risk patients with omicron infection there is only one monoclonal antibody treatment that is effective and that is in very short supply.  Neither of the recently approved drugs against the virus are available in any quantity - and the preference is for Paxlovid by Pfizer - based on efficacy and safety.  See Below 

Vaccinations are making a huge difference and this week the CDC will approve booster shots for 12-15 year old children 5 months after their 2nd vaccine dose.  Hospitalizations and severe infections in children have increased and there are many children who should still be vaccinated and if fully vaccinated should be boosted based on the CDC recommendations.  On Saturday I'll review "Isolation" and "Quarantine" recommendations that are changing in order to safely shorten time out of work for essential workers. 

Posted by Shirley at 6:02 AM | Permalink | Comments (0)

I have made Christmas Ornaments for Friends and Family since 1976 and I spent many days in the last 10 days making these Seminole Patchwork Hearts for our childrens' trees, all of our 8 grandchildren for future trees of their own, and friends.  Each year I enjoy getting out the big box of handmade ornaments, each of which is full of Christmas memories.

I will still follow the latest Covid news over the next few weeks, but I don't think there will be any major drug or vaccine news.  I will therefore take a break until Wed. January 5th.  This week the FDA approved the Paxlovid EUA and finally approved the Molnupiravir EUA, but I've already reported on both of those drugs and they won't be available yet.  New York City is in the middle of a frightening surge in cases, and there is no data yet on the number of unvaccinated, vaccinated, and boosted. We are planning to remain home enjoying the season, and doing lots of reading near the Christmas tree. 

Posted by Shirley at 6:05 PM | Permalink | Comments (0)

The are two important announcements from this week.  

Pfizer published a press release on Paxlovid, their oral drug for treating early Covid infections.  It is an anti-protease that directly affects the virus by blocking SARS-Cov-2 replication.  Treatment consists of 3 pills every 12 hours for 5 days.  If taken during the first 3 days after onset of symptoms in high risk patients it can reduce hospitalization and death by 89% (5/697 treated patients were hospitalized with no deaths; 44/682 patients who took placebo were hospitalized with 9 subsequent deaths; (p<0.0001) . Relative risk reduction was 94% in patients 65+ years.  Adverse events were the same in the treatment group (22%) and placebo (21%) and were mostly mild to moderate.  If treatment was started within 5 days of developing symptoms the reduction was 88%. They are conducting the trial in standard risk patients as well.

The drug is likely to be active against the omicron variant because the drug blocks an enzyme in viral replication. This is different from the spike protein where the 30 mutations occurred.  See Below 

On Thursday the FDA Advisory Committee met to discuss the blood clotting side effects (Thrombotic Thrombocytopenia Syndrome) that is a rare, but very significant side effect of the J and J vaccine.  The incidence is 1:100,000 but the cases that occurred since the initial FDA approval appear to have 15% mortality.  The mechanism for this serious adverse effect is being studied in many labs in various countries but no definitive discoveries were made.  The Advisory Committee unanimously approved the following statement:  "mRNA vaccines are preferred over the Janssen Covid-19 vaccine for the prevention of Covid-19 for all >18 years of age."

The J and J (Janssen) vaccine still should be used for patients who are allergic to the mRNA vaccines and in areas where the storage requirements for the mRNA vaccines would be difficult.  It is also recommended that 2 doses of the J and J vaccine be given for full vaccination.  

Posted by Shirley at 5:36 AM | Permalink | Comments (0)

One of the most important questions about the omicron variant is whether it can escape our immune protection - after a Covid infection or full vaccination. To study "immune escape" of a variant the virus or a construct of the virus is mixed with serum obtained from previously infected or vaccinated people.  Several "neutralizing antibody" studies were published this week and in general the serum samples did not "neutralize" the virus well.  But Pfizer reported their results of neutralizing antibodies in serum collected from vaccinated patients after 2 doses of vaccine or two doses of vaccine plus a booster.  I don't have detailed knowledge of these neutralizing antibody lab tests but here are their more encouraging results. My simple way of understanding these tests is - how much do the antibodies that our bodies make kill the virus of interest. 

Reported results on the Pfizer web page: 

1.  Sera from subjects who received two doses of the Pfizer Covid vaccine did exhibit, on average, more than a 25-fold reduction in neutralization titers against the omicron variant compared to the wild type virus (the original virus). This means the antibodies had much less ability to kill the omicron virus vs the original SARS-CoV-2 virus. 

2.  Serum antibodies obtained from vaccinees 1 month after subjects received a Pfizer booster vaccination neutralized the omicron variant to levels observed for the wild type (original SARS-CoV-2 virus) after two doses of the Pfizer vaccine.  The booster doses were shown to increase antibody titers 25 fold.  A third dose of vaccine also increases a type of T cells which can kill the virus.  See Below.  

The next step is to study subjects who were vaccinated with 2 doses of the Pfizer vaccine and then received a booster 6 months after their 2nd dose in order to analyze which subjects are getting infected at least a month after their booster dose - a real world observational assessment.  The CDC and the scientists working on the Covid projects are recommending that everyone receive a booster shot.  Meanwhile the company is starting to prepare a spike protein with mutations to use to make mRNA vaccines in order to cover the variants.  They also did the same thing after the emergence of the other variants, but never had to make the vaccine. I searched and couldn't find any omicron studies and the Moderna vaccine. 

Posted by Shirley at 7:32 AM | Permalink | Comments (0)

While we wait, scientists around the world are studying the omicron variant in many different ways.   One lab in Texas created a "spike protein look alike" with most of the new mutations so they can begin to study the effect of antibodies against the variant.  Other labs started the preliminary work toward a variant-specific vaccine booster.  Earlier in the pandemic labs were developing vaccines against specific alpha, beta, and delta variants of SARS-CoV-2 as they were discovered just so they would be ready to go if another variant was less controlled by our current vaccines. 

WHAT DO WE KNOW ABOUT THE OMICRON VARIANT?  

Transmission: it may be more transmissible. There is clear evidence of community spread.

Severity: probably not as severe as Delta, based on the cases seen so far.  A better indicator is the number of hospitalizations and it may be too early to assess now with the recent cases.

Immune escape:  unknown, but one of the monoclonal antibodies (Sotrovimab) was reported to have activity against omicron and the previous variants. 

But it is still too early to have hundreds of pieces of data, from the laboratories and from real world observations, testing, and genomic sequencing. I will try to cover the observations in these Blog posts/Facebook entries as they are reported over the next few weeks.  See Below

Barney Graham, a key architect of the coronavirus vaccines, recently retired from NIH.  This week, in an article from The Washington Post he said "because viruses adapt and they change, and unless we develop generalized global immunity more readily, we will always be chasing our tail."  While we wait for more omicron data, protect your family by getting vaccinated and boosted.  Remember that two doses of the mRNA vaccines are necessary to establish immunity against severe disease and death. And this AM there was a brief news report from Pfizer that the booster dose is essential and effective.  More later.

Posted by Shirley at 5:32 AM | Permalink | Comments (0)