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December 24, 2021

Merry Christmas and Happy Healthy New Year

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. 

 

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December 18, 2021

This Week's Covid News

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 

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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.  

December 11, 2021

Protect Yourself Against Omicron - Get a Booster NOW!

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.  

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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. 

December 8, 2021

WAITING and HOPING

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

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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.

December 4, 2021

Omicron Updates Week of 11.28

The Omicron variant is spreading more quickly in South Africa than the delta variant did.  Hospitalizations there are also greater than in previous waves.  The first case in the US was announced in San Francisco Wed. after travel to S. Africa. Thursday evening the NY Governor announced 5 cases in NY, one woman who was in S. Africa.  No more was known yet about the other 4.  There was also one case in Minneapolis which occurred after a man returned home from an ANIME Convention at the Javits Center in NYC from Nov 19-22nd.  There were 53,000 attendees and our Governor thinks all of them should be tested - wherever they returned to.  There are now more than a dozen cases in the US in a dozen states and as of Friday afternoon the variant was found in 36 countries.

The South Africans reported that reinfections are occurring in patients who had Covid more than 90 days ago.  This lack of immunity was not seen there previously when the beta and delta variants spread in their country.  The early anecdotes and scraps of data suggest that most of these cases are mild. However hospitalizations and deaths usually follow surges by 2 weeks, so those patients diagnosed during this early surge (from 3402 cases on 11/26 to 8561 on 12/1) will need to be assessed in several weeks for information about the severity of the Omicron infections.  See Below 

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We can't build a wall around America, but our public health advisors have encouraged more people to get vaccinated now, or get boosters if they are already vaccinated, and curtail risky behavior until more is known about our vulnerability to Omicron. Those that only had one dose of the mRNA vaccines definitely need to get a 2nd dose now for any protection.  The booster shots substantially increase antibody titers and raise the level of B and T cells which may be enough to block or reduce the Omicron infection if you are exposed.  Data reported here Friday was encouraging with 2.2 million doses of vaccine given yesterday with more than 1 million of them being booster doses. The most common question I've heard asked or read is whether people should wait for a the new Covid vaccines to be made to get a booster and the answer is always "NO!!!  Get a booster now!"  We need testing for as many symptomatic people as possible and sequencing of their viruses to know whether Omicron can compete with the delta variant which currently accounts for 100% of infections here. 

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