Effectiveness of 1st dose of BNT162b2 vax in reducing SARS-COV-2 13-24 days after immunization

 Gabriel Chodick, PhD1,2 *, Lilac Tene, MSc 1 , Tal Patalon, MD1 , Sivan Gazit, MD1 , Amir Ben Tov, MD 1 , Dani Cohen # , PhD 2 , Khitam Muhsen, PhD# 2

doi: https://doi.org/10.1101/2021.01.27.21250612

Research in context 

Evidence before this study 

We searched PubMed for follow-up studies regarding the effectiveness of BNT162b2 mRNA Covid-19 Vaccine without any language restrictions. The search terms were (BNT162b2 OR mRNA Covid-19 Vaccine) AND (effectiveness OR real-world OR phase IV) until Jan 15, 2021. We found no relevant observational studies among humans. We also assessed Phase II and Phase III clinical trials with BNT162b2 mRNA vaccine. 

Added value of this study 

To our knowledge, this is the first and largest phase IV study on the effectiveness of the BNT162b2 mRNA COVID-19 vaccine in real-world settings. Our findings showed that the first dose of the vaccine is associated with an approximately 51% reduction in the incidence of PCR-confirmed SARS-CoV-2 infections at 13 to 24 days after immunization compared to the rate during the first 12 days. Similar levels of effectiveness were found across age groups, sex, as well as among individuals residing in Arab or ultra-orthodox Jewish communities that display an increased COVID-19 risk. 

Implications of all the available evidence

 The study results indicate that in real life the first dose of the new BNT162b2 mRNA COVID19 vaccine confers around 50% protection against overall SARS-CoV-2 infections (symptomatic or asymptomatic). Together our findings and the 95% efficacy shown in the phase III trial, suggest that the BNT162b2 vaccine should be administered in two doses to achieve maximum protection and impact in terms of disease burden reduction and possibly reducing SARS-CoV-2 transmission. COVID-19 vaccines should be urgently deployed globally.

 Abstract 

Background 

BNT162b2 vaccines showed high efficacy against COVID-19 in a randomised controlled phase-III trial. A vaccine effectiveness evaluation in real life settings is urgently needed, especially given the global disease surge. Hence, we assessed the short-term effectiveness of the first dose of BNT162b2-vaccine against SARS-CoV-2 infection. Given the BNT162b2 Phase-III results, we hypothesized that the cumulative incidence of SARS-CoV-2 infection among vaccinees will decline after 12 days following immunization compared to the incidence during the preceding days.

Methods 

We conducted a retrospective cohort study using data from 2·6 million-member state-mandated health provider in Israel. Study population consisted of all members aged 16 or above years who were vaccinated with BNT162b2-vaccine between December/19/2020 and January/15/2021. We collected information regarding medical history and positive SARSCoV-2 polymerase chain reaction test from days after first dose to January/17/2021. Daily and cumulative infection rates in days 13-24 were compared to days 1-12 after first dose using Kaplan-Meier survival analysis and generalized linear models.

Findings 

Data of 503,875 individuals (mean age 59·7 years SD=14·7, 47·8% males) were analysed, of whom 351,897 had 13-24 days of follow-up. The cumulative incidence of SARS-CoV-2 infection was 0·57% (n=2484) during days 1-12 and 0·27% (n=614) in days 13-24. A 51·4% relative risk reduction (RRR) was calculated in weighted-average daily incidence of SARSCoV-2 infection from 43·41-per-100,000(SE=12·07) in days 1-12 to 21·08-per100,000(SE=6·16) in days 13-24 following immunization. The decrement in incidence was evident from day 18 after first dose. Similar RRRs were calculated in individuals aged 60 or  above (44.5%), younger individuals (50.2%), females (50.0%) and males (52.1%). Findings were similar in sub-populations and patients with various comorbidities. 

Conclusions 

We demonstrated an effectiveness of 51% of BNT162b2 vaccine against SARS-CoV-2 infection 13-24 days after immunization with the first dose. Immunization with the second dose should be continued to attain the anticipated protection.

https://www.medrxiv.org/content/10.1101/2021.01.27.21250612v1.full.pdf

Healthcare & Life Sciences IPO Recap, week of Jan. 25

 

Health & Life Sciences IPOs During the Week of January 25th, 2021
Issuer Business	Deal Size	Market Cap at IPO	Price vs. Midpoint	First Day Return	Return at 01/29
Ignyte Acquisition (IGNYU)	$50M	$64M	0%	+3%	+3%
Blank check company targeting the life sciences, biotechnology and healthcare sectors.
Biotech Acquisition (BIOTU)	$200M	$250M	0%	+3%	+3%
CA Healthcare Acquisition (CAHCU)	$100M	$125M	0%	+2%	+3%
Blank check company targeting the healthcare industry.
HealthCor Catalio Acq. (HCAQ)	$180M	$225M	0%	+0%	+1%
Blank check company formed by HealthCor Management and Catalio Capital Management targeting healthcare.
EQ Health Acquisition (EQHA.U)	$191M	$239M	0%	n/a	+0%
Blank check company formed by EQ Capital Strategies and FS Investments targeting healthcare services.
Ortho Clinical (OCDX)	$1,292M	$3,905M	-21%	-5%	-3%
Carlyle-backed global provider of in vitro diagnostic products. https://www.renaissancecapital.com/IPO-Center/News/75862/US-IPO-Weekly-Recap-January-closes-out-with-3-billion-dollar-deals-in-an-8-

Novavax may offer world's next viable vaccine; promising news can't cure market volatility

 

NVAX  (212.76 +78.75)

Not so long ago, positive vaccine news provided the antidote to whatever concern might be ailing the stock market, whether it be growth concerns, geopolitical turmoil, or rising virus cases. Strangely enough, the crazy trading action in heavily shorted names like GameStop (GME) and AMC Entertainment (AMC) turned out to be the kryptonite to this formerly reliable crutch. While the broader market sinks lower as investors weigh the potential implications of the short-squeeze mania, shares of Novavax (NVAX) are rocketing higher after reporting efficacy data for its COVID-19 vaccine, NVX-CoV2373, after the close last night. With an overall efficacy rate of 89.3%, the vaccine met the primary endpoint, setting the stage for a likely emergency use authorization filing in the near future. The massive gains in the stock seem shocking given that vaccines from Pfizer (PFE) and Moderna (MRNA), both of which are already available on an emergency use basis, achieved higher efficacy rates. Specifically, those vaccines are reported to be ~95% effective against contracting the virus. However, there are a couple important factors that distinguish NVAX's vaccine from the others. NVAX disclosed that its vaccine offered 60% protection against the more concerning South African variant of the virus. That is far lower than 95.6% efficacy rate versus the original strain, but it may be strong enough to significantly slow the spread of the more dangerous variant. This is especially important because it's already known that the vaccines from PFE and MRNA are not as effective against the South African strain. In fact, MRNA is currently working on a booster shot to guard against the new variant because its uncertain how long the current shot will provide any protection. NVAX's vaccine is seen as more practical and convenient because it's a single dose rather than a two-dose regiment, like PFE's and MRNA's. Also, since NVAX used a more traditional method to create the vaccine, it can transport doses at normal refrigeration temperatures instead of the extreme cold temperatures required for messenger RNA-based vaccines.  The simpler logistics should allow more people to get the vaccine quicker. In the weeks leading up to today's data release, NVAX secured deals with various governments to supply its vaccine, including Canada's (up to 76 mln doses), Australia's (51 mln doses), and the EU (up to 200 mln doses). With major manufacturing agreements in place, including with the Serum Institute of India, the company is positioned to immediately begin mass production, assuming the vaccine gains regulatory approval. Today's launch higher adds to NVAX's breathtaking gains over the past year. With the stock up an astounding ~3,000% yr/yr, it would seem that the promising vaccine news is priced in at this point. In this unusual trading environment, though, nothing can be completely dismissed, including another sharp move higher when and if NVAX's vaccine receives approval. https://www.briefing.com/#IN20210129125852NVAX

Brazil to receive 10-14M AstraZeneca vaccine doses starting mid-Feb.

 Brazil will receive between 10 million and 14 million doses of AstraZeneca's coronavirus vaccine starting in mid February through the World Health Organization’s COVAX program, the health ministry said on Saturday.

Brazil has had 58,462 new confirmed cases of the novel coronavirus reported in the past 24 hours, and 1,279 deaths from COVID-19, the ministry said.

The South American country has now registered 9,176,975 cases since the pandemic began, while the official death toll has risen to 223,945, according to ministry data, in the world's third worst outbreak outside the United States and India and its second-deadliest.

The health ministry said it had received a letter from the WHO about the delivery of the vaccine, which AstraZeneca developed in partnership with Oxford University.

On Friday, Brazilian health regulator Anvisa said that AstraZeneca had applied for full regulatory approval, a positive note for the country’s difficult vaccine rollout.

The submission, the first of its kind in Brazil, was made by the federally funded Fiocruz Institute, which will manufacture the British vaccine locally.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Brazil-to-receive-10-14-mln-AstraZeneca-vaccine-doses-starting-mid-February-health-mi-32315130/

Finally, Gov. Cuomo is called to task

 There’s a truth that the media and others who fawned over Gov. Cuomo didn’t want to hear: that his executive orders were one of the biggest reasons why so many of our parents and grandparents died of COVID in their eldercare facilities. 

We lost more seniors from COVID in nursing homes than 9/11 and Hurricane Katrina combined. That includes my husband’s parents, Mickey and Dee Newman. Why didn’t this fact spark outrage? 

Now we finally know why, and it’s what we suspected for many months: because this administration has been doing everything it could to keep that information hidden by blaming, bullying, lying and covering up. 

I’ve personally been attacked by the governor’s spokespeople as have my family and the other brave people that dared to go against this administration. I was told that I wasn’t a credible about anything except the weather and that I was part of a death cult that wouldn’t stop hounding Cuomo or his office. I was warned to “watch my back” and “be careful.” He was too powerful, both revered and feared by those that covered him and worked for him. 

Meanwhile, our grieving families continued to watch the mainstream media outlets fawn over him and never ask the questions we so desperately wanted to know: Why did he write that executive order to bring infected patients into nursing homes, and why was he covering up the total number of seniors who died including those who passed away in the hospital? 

New York may have undercounted COVID-19 deaths among nursing home residents by thousands, the state attorney general charged in a report.

AP Photo/Hans Pennink, Pool, File

We never heard the answers. Instead, we watched him promote and celebrate himself, write his leadership book, and win an Emmy Award. 

It was infuriating. Frustrating. Soul crushing. And despite all my attempts for accountability, I was starting to believe we might never see the day that this governor and his administration were called to task. 

Until now. A 76-page report from the New York Attorney General’s Office that finally gave us reason to believe that the nightmare we were going through was very real. 

Our feelings of hurt, dismay, anger, betrayal from this leader and his Heath Department were valid. What we knew in our hearts was the truth. 

In her report, James wrote: 

“While we cannot bring back the individuals we lost to this crisis, this report seeks to offer transparency that the public deserves and to spur increased action to protect our most vulnerable residents.” 

That’s the part that made me cry. Because we can’t bring back my husband’s parents, but I believe that they helped give me the strength to not give up. 

I called my husband and his sister and told them Mickey and Dee didn’t give up. They helped us to keep going. 

Because those we lost are the ones we are fighting for. 

This report is a door opening, with a glimmer of light peeking through. Perhaps there may be justice, and their deaths will not have been in vain. 

I do hope we see a full investigation into the nursing-home massacre here in New York. These deaths could’ve been prevented. Maybe this is the beginning of protecting other families in the future. 

But first, we need the whole truth and nothing but the truth. From this governor, his Health Department and all those that helped cover it up. Because we deserve that. My husband’s parents deserve that. 

Gov. Cuomo said this week in an interview on one of the channels that never asked him questions about the nursing-home tragedy: 

“Incompetent government kills people. More people died than needed to die in COVID. That’s the truth.” 

Turns out he was talking about himself. 

Janice Dean is the senior meteorologist and an anchor for Fox News.

https://nypost.com/2021/01/28/finally-gov-cuomo-is-called-to-task/

Jefferies Names Possible Hedge Fund Short Targets

 Jefferies' equity strategist Steven DeSanctis said while in football targeting will get you ejected, in today's market, some cheer you on.

Amid the ongoing short squeezes in GameStop (NYSE: GME), AMC (NYSE: AMC), Express (NASDAQ: EXPR), and others, the strategist highlighted some others that could be ripe.

DeSanctis highlighted that, just as market veteran Art Cashin points out, short selling is nothing new.

He said looking across the six portfolios they track, they have seen the most-shorted names rise 13.4% this month and they're up 157% from the low. In contrast, the Most Popular Longs by Hedge Funds are off by 4.9%, and the UBER Crowded names have slipped 5.6%. For those names that are owned by Long Only folks but Short by Hedge Funds, these stocks are up 9.6% and 110% from 3/18. This all comes on the back of the S&P 500 being basically flat

DeSanctis comments: "Looking for shorts to trade, we offer a few selections on our menu: The data provided by our friends at MSCI allow us to build portfolios based on Net Short positions, those names that have gone from Long to Short. We also add a sprinkle of liquidity, or lack there of, along with biggest shorts by sector. The Margin Table gives you Net Short that are tougher to trade and could see more volatility, especially over the next several days/ weeks. We also look at names that moved from Long to Short and here are the 20 in our portfolio: AYX, BIIB, CME, DPZ, DUK, EIX, ESPR, FDX, HOLX, IIPR, CME, LHX, NVCR, PFE, PNC, ROK, ROP, URI, WDC, YUMC."

https://www.streetinsider.com/Analyst+Comments/Jefferies+Names+Possible+Hedge+Fund+Short+Targets/17884750.html

First study to look at potency of maternal antibodies

 Research shows that certain segments of the population who contract SARS-CoV-2, the strain of the virus that causes COVID-19, tend to get sicker and are at higher risk for worse outcomes, and that includes pregnant women and infants under two months.

In a new study to be presented today at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting, The Pregnancy Meeting™, researchers will unveil findings that suggest that women who contract COVID-19 during pregnancy are able to make antibodies, but that transfer of these antibodies to their infants is less than expected.

Antibodies are produced by the body's immune system to help fight against infection. Specifically, the study looked at immunoglobulin G (IgG) and neutralization activity, a measure of the potency of antibody response, in the maternal immune system.

IgG antibodies make up approximately 75 percent to 80 percent of all the antibodies in the body and can cross the placenta to the fetus. Neutralizing antibodies block infection and make viruses less active.

"A recent study analyzed maternal antibody response to infection, but our study is the first to look at the maternal immune response and neutralizing antibodies," said one of the study's lead authors Naima Joseph, MD, MPH, a clinical fellow in maternal-fetal medicine at Emory University School of Medicine and a member of the SMFM COVID-19 Task Force. "We also looked at the transfer of those antibodies across the placenta to the fetus."

The study analyzed maternal and umbilical cord blood samples from 32 women who tested positive for COVID-19 during pregnancy. Of the maternal samples collected, 100 percent contained IgG and 94 percent contained neutralizing antibodies. Of the cord blood samples, 91 percent contained IgG and 25 percent contained neutralizing antibodies.

"What was interesting about this study is that even if a woman was asymptomatic, she still developed high levels of COVID-19 IgG and neutralizing antibodies," said Joseph.

"A major way that infants are protected from infection is from the antibodies that they receive in utero, so whether a woman was asymptomatic or not, we would have expected to see a higher percentage of antibodies transferred from mother to infant, especially neutralizing antibodies," said another of the study's lead authors, Martina L. Badell, MD, a maternal-fetal subspecialist and associate professor at Emory University School of Medicine. "The next step is to understand why antibody transfer is different in COVID-19 infection from other infections and whether the transfer of these antibodies increases when we vaccinate a pregnant woman."

https://www.eurekalert.org/pub_releases/2021-01/sfmm-fst012721.php