COVID 19 Vaccines (notes)

 VACCINES

General Vaccine Notes -
New England Journal of Medicine Covid-19 Vaccine Resource Center
A collection of resources on Covid-19 vaccines, including published research, continuing medical education, and commentary. See also the NEJM 

SARS-CoV-2: Unique Challenges of the Virus and Vaccines
"The aim of this article is to provide a review of the attempts made to develop safe SARS-CoV-2 vaccines, highlighting potential challenges and concerns, such as disease enhancement, virus mutations, and public acceptance of the vaccine."

The Covid-19 Vaccine-Development Multiverse 

A Possible Role for Anti-idiotype Antibodies in SARS-CoV-2 Infection and Vaccination

COVID-19 Vaccine Emergency Use Authorization (EUA) Fact Sheets for Recipients and Caregivers

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States

How protein-based COVID vaccines could change the pandemic

List of which jobs qualify someone as a "frontline worker"

How to file a report of a vaccine injury

The VAERS Vaccine Adverse Events Reporting System with the CDC

How to file a report of a vaccine injury

Absolute BEST Covid-19 Religious Exemption Letter! | Tough Topics | Anthony Wade

EU drug regulator expresses doubt on need for fourth booster dose
"The European Union's drug regulator on Tuesday expressed doubts about the need for a fourth booster dose of COVID-19 vaccine and said there is currently no data to support this approach as it seeks more data on the fast-spreading Omicron variant.

"While use of additional boosters can be part of contingency plans, repeated vaccinations within short intervals would not represent a sustainable long-term strategy," the European Medicines Agency's Head of Vaccines Strategy, Marco Cavaleri, told a media briefing.

The EMA official raised concerns that a strategy of giving boosters every four months hypothetically poses the risk of overloading people's immune systems and leading to fatigue in the population."

Differential Kinetics of Immune Responses Elicited by Covid-19 Vaccines
 
AstraZeneca/Oxford vaccine -
When study participants were given both shots at intended dose (it is a two shot series), efficacy was around 62% (62% of people were protected from COVID, need more info about how that is defined).  When the first dose was accidentally given at half intended dose, but second dose was full dose, efficacy was 90%.  More studies being done to see if this difference in efficacy is real, and if so, why.  For now AZ is combing the results and claiming vaccine is about 70% effective overall.  This vaccine is less expensive than other front runners and requires less extreme cold storage (this introduces a lot of logistical challenges for other vaccines that require storage at much colder temperatures).

Pfizer/BioNTech vaccine (BNT162b2) -
This vaccine was developed via a partnership between Biotech (a German company) and Pfizer.  Results were recently reported for the phase 3 trial, which was a randomized controlled trial with 44,000 participants.  Half of the subjects were given the vaccine and half were given a placebo (which was not a placebo).  At the end of the trial (how long was the trial?) 94 subjects had confirmed cases of coronavirus (how were cases confirmed?).  Much of the information about this trial has not been released yet (as of early November), but it has been calculated that if the effectiveness that was reported  of around 90% (why is this different than the 95% figure given elsewhere?) than no more than 9 of the 94 subjects who got sick were given the vaccine.  Final approval will be considered once the number of test subjects who get infected reaches 164. With such a brief period of study, and without more details about the trial, it is still to be seen whether the effectiveness rate is consistent in different populations, what long-term consequences and side effects there will be, how long the acquired immunity will last,  whether it will prevent people from being able to transmit the virus to others.  Pfizer says they will be able to make enough vaccine for 650 million people by the end of 2021 which isn't nearly enough for the global need.  It is estimated that around 4 billion people globally will need to be vaccinated in order to reach herd immunity. 

This vaccine was designed to introduce particles of mRNA (messenger RNA), the molecule that carries genetic information from the DNA to the organelle in the cell called a ribosome, which than makes the protein that the mRNA strand codes for.  In this case the mRNA contains instructions for making the spike protein which is on the surface of the virus and allows the virus to enter cells and cause infection.  The idea is that the body will than use these spike proteins to make antibodies against the virus so that the body can fight off the real virus more effectively when it encounters it in the future.  It is claimed that this vaccine could be altered relatively easily to fight additional versions of the virus created when mutations happen (which they already have). 

The Pfizer vaccine needs to be administered as two doses, given 21 days apart. It also needs to be kept at -94 degrees F, which introduces serious logistical problems. It can be stored at that ultra low temperature for as long as 6 months, but also kept at 35 to 46 degrees for up to 5 days. The company reports that if the vaccine warms up too much, the mRNA particles change shape and become ineffective. In much of the world there simply is not enough resources to store the vaccine at this low temperature. Even in the US few hospitals have the kind of freezers that can do this. Dry ice can be used, but that is only a temporary measure until it melts and getting more of it to where it is needed is problematic for the same reason that transporting the vaccine is in the first place. The type of freezer required for storage at such cold temperatures cost around $10 K to $15 each. Here in the US many hospitals have been operating at a loss for much of the pandemic so the high cost is a significant 
barrier. 

COVID Vaccine Explained In 6 Minutes

Why The Covid-19 Vaccines Must Be Kept So Cold

Israeli study finds 94% drop in symptomatic COVID-19 cases with Pfizer vaccine

A large study in Israel involving around 600,000 people has found that the Pfizer vaccine reduces symptomatic COVID 19 cases by 94% and 92% less likely to develop a severe case of the disease.  This data was analyzed one week after people had received their second dose.  There has been a significant reduction in hospitalizations in the vaccinated group. 

Moderna vaccine (mRNA-1273) -
This vaccine also needs to be kept at a lower temperature than usual for vaccines, although the -4 degrees F it requires makes the logistics of transporting and storing it less problematic.  

Novavax -
NOVAVAX: A “Traditional” VACCINE for COVID-19 soon to be released?

NVX-CoV2373 Covid-19 Vaccine ("quick take" from New England Journal of Medicine)

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine
"A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax)"

Novavax COVID Jab Approved by MHRA
"Nuvaxovid is a recombinant, adjuvanted vaccine composed of purified full-length SARS-CoV-2 recombinant spike protein, adjuvanted with Matrix-M, which enhances the magnitude of the S protein-specific immune response.  Matrix-M is Novavax’s patented preparation of extracts from the bark of Quillaja saponaria Molina, the Chilean soapbark tree, which has strong adjuvant and antiviral properties, together with cholesterol and phospholipid.

The spike protein in Nuvaxovid is produced by recombinant DNA technology using a baculovirus expression system in an insect cell line derived from Sf9 cells of the Spodoptera frugiperda species, commonly known as the fall armyworm.

The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralizing antibodies, which may contribute to protection against COVID-19.

"The technology is really very different from both the viral and the mRNA vaccines," according to Filip Dubovsky, chief medical officer at Novavax. "The full length spike protein does have common epitopes that span all the variants, and in fact epitopes that go back even to the original SARS. So the benefit of the native conformation... is that it’s pretty much identical to the virus naturally. On top of that, the adjuvant really focuses and broadens the immune response."

Johnson and Johnson vaccine (Ad26.COV2.S) -
Mayo Clinic Insights: What you should know about the Johnson & Johnson COVID-19 vaccine
The vaccine reaches it's full protective potential by 2 weeks after someone receives it.

Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile
"The study was conducted from February 2 through May 1, 2021, and the cohort included approximately 10.2 million persons. Among persons who were fully immunized, the adjusted vaccine effectiveness was 65.9% (95% confidence interval [CI], 65.2 to 66.6) for the prevention of Covid-19 and 87.5% (95% CI, 86.7 to 88.2) for the prevention of hospitalization, 90.3% (95% CI, 89.1 to 91.4) for the prevention of ICU admission, and 86.3% (95% CI, 84.5 to 87.9) for the prevention of Covid-19–related death."

Soberana 02 and Abdala (used in and developed in Cuba)
"Soberana 02 is more than 90% effective in protecting against symptomatic COVID-19 infection when used in combination with a related vaccine. Importantly, the combination seems to be effective against the highly transmissible Delta variant of the coronavirus SARS-CoV-2, which has caused surges in hospitalizations and death across the world and now accounts for nearly all COVID-19 cases in Cuba.

As of 18 November, 89% of Cuba’s population — including children as young as 2 — has received at least one dose of Soberana 02 or another Cuban vaccine called Abdala, which is produced at the Center for Genetic Engineering and Biotechnology (CIGB) in Havana. The centre reported in July that Abdala, a three-dose vaccine, was more than 92% effective in phase III trials that included more than 48,000 participants, but the full results have not yet been published.

To improve on this protection, the Finlay team also gave participants a third shot. The researchers had previously tested a jab called Soberana Plus on people already sick from COVID-19 and found that it improved their immune response. So they gave Soberana Plus, which is based on the RBD protein alone, to another set of 14,000 participants who had already received two Soberana 02 doses — and discovered that the third dose raised overall efficacy to 92.4%."

Additional Vaccines
Intranasal vaccines for SARS-CoV-2: From challenges to potential in COVID-19 management
"Unlike conventional Coronavirus 2019 (COVID-19) vaccines, intranasal vaccines display a superior advantage because the nasal mucosa is often the initial site of infection. Preclinical and clinical studies concerning intranasal immunization elicit high neutralizing antibody generation and mucosal IgA and T cell responses that avoid severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in both; the upper and lower respiratory tract. A nasal formulation is non-invasive with high appeal to patients. Intranasal vaccines enable self-administration and can be designed to survive at ambient temperatures, thereby simplifying logistical aspects of transport and storage. In this review, we provide an overview of nasal vaccines with a focus on formulation development as well as ongoing preclinical and clinical studies for SARS-CoV-2 intranasal vaccine products."

Researchers develop patent-free Covid vaccine for developing nations

Africa's first mRNA COVID-19 vaccine uses Moderna data

mRNA Vaccine Technology
An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development
"The production of mRNA-based vaccines is a promising recent development in the production of vaccines. However, there remain significant challenges in the development and testing of vaccines as rapidly as possible to control COVID-19, which requires international collaboration. This review aims to describe the background to the rationale for the development of mRNA-based SARS-CoV-2 vaccines and the current status of the mRNA-1273 vaccine."

How mRNA Technology Could Change the World

Clinical and immunological effects of mRNA vaccines in malignant diseases
"This review will summarize the most recent technological developments and application of mRNA vaccines in clinical trials and discusses the results, challenges and future directions with a special focus on the induced innate and adaptive immune responses."

Reporting Relative Risk vs Absolute Risk in Clinical Trials
Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19
"The Consolidated Standards of Reporting Trials guidelines recommend reporting both the absolute risk reduction and the relative risk reduction to fully describe the effectiveness of an intervention, as applied in many trials, including the recent trial of bamlanivimab–etesevimab combination for Covid-19.² This practice is imperative, because the same relative risk reduction may represent very different absolute risk reductions — a relative risk reduction of 80% corresponds with an absolute risk reduction of 40% when the absolute risk decreases from 50% to 10% but with an absolute risk reduction of less than 1% when the absolute risk decreases from 1% to 0.2%. The provision of only the relative risk measure may lead clinicians, patients, and laypeople to overestimate treatment efficacy."

Vaccine Effectiveness in Reducing Pathogenicity and Transmissability of COVID 19
Lies and Exaggerations Re: Kids Vax Under 5 Is Bad Public Health
Dr Prasad argues that for the good of public health, policymakers need to be honest and transparent or they risk losing public trust.  It also undermines people's autonomy in choosing their healthcare.  In this specific case, at least 75% of eligible children have already had COVID 19, and the claim that even these children are better off getting the vaccine because it improves upon their natural immunity is a guess and not based on any evidence.  Another claim that is made without any supporting evidence is that children under 5 are protected against hospitalization and long COVID by getting vaccinated, but the studies around this were way too small to establish anything about serious illness (which is very rare in young children), and not only was long COVID not looked at in these studies but there isn't even a definition yet for what constitutes long COVID in children.  We have no evidence that vaccination is associated with any positive health outcomes in children under 5.  The claim that poor health outcomes, including death, or more common in unvaccinated kids compared with vaccinated kids is misleading because it is asserting a correlation but does not establish causality.  The real question is whether vaccinating a young child reduces their risk of poor outcomes.  There are many reasons why vaccinated kids may be different than unvaccinated kids that could be confounding factors here.  Also, that study omitted people who were hospitalized soon after being vaccinated because the vaccine may not have become active yet, but these patients were not excluded from the unvaccinated population so effectively one group of vaccinated people who were hospitalized were counted in the unvaccinated group, which can alter the results.  

There is a claim that both vaccines available for young children have an efficacy of 37-80%.  The 37% is based on the Moderna trials which only counted infections that were found with specific tests at specific labs.  When they did a "sensitivity analysis" and included all positive tests the vaccine efficacy dropped to 28.5%.  The 80% seems to be based on Pfizer data which had a huge confidence interval, meaning the data is not reliable, and they also excluded cases shortly after vaccination that need to be included.  The reason is that what is being studied is whether choosing to be vaccinated changes your risk of bad outcomes, so everything that happens after the vaccination needs to be included.  The EUA for Pfizer for children under 5 it actually says that there weren't enough study participants for the occurrence of infection to be meaningful. Dr Prasad also points out the "politicizing" of vaccination and how that can alienate people and reduce credibility, and how Dr Fauci has control over who gets what research funding and that this could be discouraging people from coming forward with concerns because they fear losing their research grants and careers.  Lastly, the PR campaign encouraging vaccination feels like a slick sales job rather than reputable science.

Vaccines Fail to Confer Good Protection from Long COVID after Breakthrough Infection
"the findings suggest that vaccination before infection confers only partial protection in the post-acute phase of the disease; hence, reliance on it as a sole mitigation strategy may not optimally reduce long-term health consequences of SARS-CoV-2 infection."
(note- this paper gives a lot of specific risk ratios for many different outcomes in many study and control groups.)

Increases in COVID-19 are unrelated to levels of vaccination across 68 countries and 2947 counties in the United States
"At the country-level, there appears to be no discernible relationship between percentage of population fully vaccinated and new COVID-19 cases in the last 7 days (Fig. 1). In fact, the trend line suggests a marginally positive association such that countries with higher percentage of population fully vaccinated have higher COVID-19 cases per 1 million people. Notably, Israel with over 60% of their population fully vaccinated had the highest COVID-19 cases per 1 million people in the last 7 days. The lack of a meaningful association between percentage population fully vaccinated and new COVID-19 cases is further exemplified, for instance, by comparison of Iceland and Portugal. Both countries have over 75% of their population fully vaccinated and have more COVID-19 cases per 1 million people than countries such as Vietnam and South Africa that have around 10% of their population fully vaccinated.

Across the US counties too, the median new COVID-19 cases per 100,000 people in the last 7 days is largely similar across the categories of percent population fully vaccinated (Fig. 2). Notably there is also substantial county variation in new COVID-19 cases within categories of percentage population fully vaccinated. There also appears to be no significant signaling of COVID-19 cases decreasing with higher percentages of population fully vaccinated"

'80% of serious COVID cases are fully vaccinated' says Ichilov hospital director
“Right now, most of our severe cases are vaccinated,” Jerris told Channel 13 News. “They had at least three injections. Between seventy and eighty percent of the serious cases are vaccinated. So, the vaccine has no significance regarding severe illness, which is why just twenty to twenty-five percent of our patients are unvaccinated.”

"Jerris also revealed some of the confusion in reporting cases. Speaking at a cabinet meeting on Sunday, he told ministers, “Defining a serious patient is problematic. For example, a patient with a chronic lung disease always had a low level of oxygen, but now he has a positive coronavirus test result which technically makes him a ‘serious coronavirus patient,’ but that’s not accurate. The patient is only in a difficult condition because he has a serious underlying illness.” 

Recent Statistics From Ontario, Canada (Last updated: March 3, 2022 at 7:31 a.m. (EST))
The majority of patients hospitalized in Ontario, including those in the ICU, are fully vaccinated.  Towards the end of February fully vaccinated people became the group with the highest infection rate, passing up the unvaccinated, after all 3 groups (including partially vaccinated people) showed a similar decline in rates.  These data also show that for the month of February 2022, fewer than one quarter of adults in ICU were there due to COVID with the percent lowering throughout the month. 

Outbreak of COVID in Fully Vaccinated and Tested Cruise Ship Passengers and Crew
"Anna Durbin, MD, director of the Center for Immunization Research at Johns Hopkins Bloomberg School of Public Health, stated at a press briefing in September 2020, “Vaccines are designed to prevent serious illness, not to prevent infection or prevent any symptoms.  The vaccinated are not as protected as they think,” said Eric Topol, MD, director of the Scripps Research Translational Institute. “They are still in jeopardy."

"On May 1, 2021 the CDC abruptly stopped tracking COVID in vaccinated people, also known as “breakthrough cases,” unless the illness was severe enough to cause hospitalization or death. “I was shocked,” said Leana Wen, MD, a physician and visiting professor of health policy and management at George Washington University. “I have yet to hear a coherent explanation of why they stopped tracking this information.” While vaccines reportedly continue to shield vaccinated people against the worst outcomes, those who have gotten COVID vaccine and still become infected with the virus are, in fact, often miserably sick and may chafe at the notion that their cases are not being accurately counted."

"While the true number of COVID breakthrough cases in vaccinated persons is unknown, infectious disease experts hint that breakthrough cases are more likely than the current data suggest. “I think that if we started to test people just randomly on the street, we would find a lot more people who test positive,” noted Abraar Karan, MD, an infectious diseases fellow at Stanford."

"Journalist David Wallace-Wells, who spoke to scientists at Harvard and Scripps, said public health officials may be “overstating the vaccine effect on transmission and understating the scale and risk of breakthrough infections."

Covid-19 Infections in Vaccinated Health Care Workers

Resurgence of SARS-CoV-2 Infection in a Highly Vaccinated Health System Workforce
"The dramatic change in vaccine effectiveness from June to July is likely to be due to both the emergence of the delta variant and waning immunity over time, compounded by the end of masking requirements in California and the resulting greater risk of exposure in the community."

Breakthrough Infections in BNT162b2-Vaccinated Health Care Workers
"Vaccinated health care workers can be infected with variants of concern transmitted from unvaccinated household contacts and may transmit SARS-CoV-2 in the hospital if not screened early enough. Finally, variants of concern may not only be more transmissible than the original SARS-CoV-2 but may also escape vaccine protection more frequently."

Covid-19 Breakthrough Infections in Vaccinated Health Care Workers
"Among fully vaccinated health care workers, the occurrence of breakthrough infections with SARS-CoV-2 was correlated with neutralizing antibody titers during the peri-infection period. Most breakthrough infections were mild or asymptomatic, although persistent symptoms did occur."

Risk of infection, hospitalisation, and death up to 9 months after a second dose of COVID-19 vaccine: a retrospective, total population cohort study in Sweden
"We found progressively waning vaccine effectiveness against SARS-CoV-2 infection of any severity across all subgroups, but the rate of waning differed according to vaccine type. With respect to severe COVID-19, vaccine effectiveness seemed to be better maintained, although some waning became evident after 4 months. "

Bivalent Covid-19 Vaccines — A Cautionary Tale

Singapore's daily caseload surges past 2,200 despite 82% vaccination rate

Covid Outbreak In Duke University - 97.8% Are Fully Vaccinated 2.2% Are Unvaccinated

CDC study shows three-fourths of people infected in Massachusetts coronavirus outbreak were vaccinated but few required hospitalization
"Critically, the study found that vaccinated individuals carried as much virus in their noses as unvaccinated individuals, strongly suggesting that vaccinated people could spread the virus to others."
This is the scientific report that the above article is based on:
Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021

Ireland reports 50% of COVID tests are positive
At the end of December 2021, Ireland had a vaccination rate over 90% at the same time that COVID testing was finding a 50% positivity rate. 

Waning Immune Humoral Response to BNT162b2 Covid-19 Vaccine over 6 Months
"Six months after receipt of the second dose of the BNT162b2 vaccine, humoral response was substantially decreased, especially among men, among persons 65 years of age or older, and among persons with immunosuppression."

Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar
"BNT162b2-induced protection against SARS-COV-2 infection appeared to wane rapidly following its peak after the second dose, but protection against hospitalization and death persisted at a robust level for 6 months after the second dose. (Funded by Weill Cornell Medicine–Qatar and others.)"

Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel
"In this study involving participants who were 60 years of age or older and had received two doses of the BNT162b2 vaccine at least 5 months earlier, we found that the rates of confirmed Covid-19 and severe illness were substantially lower among those who received a booster (third) dose of the BNT162b2 vaccine."

Effectiveness of Covid-19 Vaccines in Ambulatory and Inpatient Care Settings

Boosters and antivirals
Dr John Campbell discusses latest data (Nov 4, 2021) from UK, Israel regarding the need for, and effectiveness, of booster shots for COVID vaccines.

Johnson and Johnson Vax: One & done? Or is a booster coming? | A Doctor Reflects
The efficacy of the J and J vaccine is in the high 70s to mid 80%, and some preliminary research is showing that with a booster dose (of the J and J vaccine) protection from hospitalization is almost complete.  In August, Paul Sacks wrote an op ed in the New York Times suggesting that people who had a single J and J vaccine should consider getting a booster of an mRNA vaccine, particularly Pfizer.  For Dr Prasad, the outstanding question is about the rate of VITT (Vaccine Induced Thrombotic Thrombocytopenia) because this is the major complication coming from the adenovector vaccines, which are J and J and AstraZeneca.  So Dr Prasad's question is that given the high efficacy of the J and J single dose vaccine, and the real (but not yet quantified) risk of VITT, how will the risk vs benefit play out?

Vaccine Breakthrough Infections with SARS-CoV-2 Variants
"...we identified 2 women with vaccine breakthrough infection. Despite evidence of vaccine efficacy in both women, symptoms of coronavirus disease 2019 developed, and they tested positive for SARS-CoV-2 by polymerase-chain-reaction testing. Viral sequencing revealed variants of likely clinical importance, including E484K in 1 woman and three mutations (T95I, del142–144, and D614G) in both. These observations indicate a potential risk of illness after successful vaccination and subsequent infection with variant virus, and they provide support for continued efforts to prevent and diagnose infection and to characterize variants in vaccinated persons."

New Guidance on Booster Shots Gets Ahead of the Science New York Times Op Ed
There’s also inadequate data on the safety of third doses. The C.D.C. was honest about that. The advisory committee for the agency said it was unsure how many cases of the heart-inflammation condition myocarditis — the most common serious adverse event in young adults — a third dose might cause. Although the number is unlikely to be high, it’s not clear whether the number of young people who might be helped by a booster is greater than the number who might be hurt. The C.D.C.’s committee presented data on this that was inconclusive, and ran models that were openly based on guesses. We appreciated their transparency on that."

The Future of SARS-CoV-2 Vaccination — Lessons from Influenza
Findings summarized in this article
Study shows dramatic decline in effectiveness of all three COVID-19 vaccines over time

SARS-CoV-2 Variants and Vaccines

COVID-19 Pneumonia in Vaccinated Population: A Six Clinical and Radiological Case Series
"These data suggested that in fully vaccinated people, caution should be preserved, and the use of masks and social distancing should be continued in all closed environments. However, further clinical trials should be done to better understand how various factors can influence vaccine immunogenicity as the presence of virus mutations, age factors, and the presence of an immunocompromised state."

Comparison of two highly-effective mRNA vaccines for COVID-19 during periods of Alpha and Delta variant prevalence
"The occurrence of breakthrough infections and reports of diminished neutralization of emergent variants by vaccine-elicited sera mandate the continual monitoring of the comparative effectiveness and durability of COVID-19 vaccines.^8,9 Overall, we find that in our study population from Minnesota, both vaccines strongly reduce the risk of SARS-CoV-2 infection and severe COVID-19, but individuals vaccinated with mRNA-1273 were about half as likely to experience breakthrough infections as individuals vaccinated with BNT162b2. This relative risk reduction conferred by mRNA-1273 was also observed in other states, including in Florida during a recent COVID-19 outbreak. The effectiveness of both vaccines, particularly BNT162b2, was lower in July compared to prior months. Finally, the rates of complications experienced by patients with breakthrough infections were similar between those vaccinated with mRNA-1273 or BNT162b2."

Duke University mandates Covid vaccines for staff and reinstitutes mask rules following outbreak
"Duke University on Monday enacted a vaccine mandate for staff and a mask requirement for the entire campus after a Covid-19 outbreak infected nearly 350 students and 15 employees to start the fall semester. The university, which instituted a Covid vaccine requirement for students earlier this year, said 98% of all students are fully immunized. Just eight people involved in the outbreak are unvaccinated and a majority are asymptomatic, the statement said."

Effect of Covid-19 Vaccination on Transmission of Alpha and Delta Variants
"Vaccination was associated with a smaller reduction in transmission of the delta variant than of the alpha variant, and the effects of vaccination decreased over time. PCR Ct values at diagnosis of the index patient only partially explained decreased transmission."

What is the vaccine effect on reducing transmission in the context of the SARS-CoV-2 delta variant?
"SAR among household contacts exposed to fully vaccinated index cases (25%; 95% CI 15–35) was similar to household contacts exposed to unvaccinated index cases (23%; 15–31).  Reducing transmission is necessary to reduce virus circulation, reach herd immunity and end this tragic pandemic. This study confirms that COVID-19 vaccination reduces the risk of delta variant infection and also accelerates viral clearance in the context of the delta variant. However, this study unfortunately also highlights that the vaccine effect on reducing transmission is minimal in the context of delta variant circulation. These findings have immediate public health implications. "

Vaccine Safety Research -
Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults
"In 2020, prior to COVID-19 vaccine rollout, the Brighton Collaboration created a priority list, endorsed by the World Health Organization, of potential adverse events relevant to COVID-19 vaccines. We adapted the Brighton Collaboration list to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials.

Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.

Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI -0.4 to 20.6 and -3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI -23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI -3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).  

The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets."

The UK government has extended the recommended length of time between a COVID 19 infection and receipt of a vaccination against COVID to 3 months to reduce the risk of Myocarditis and Pericarditis. 

Efficacy and Safety of the RBD-Dimer–Based Covid-19 Vaccine ZF2001 in Adults

Efficacy and Safety of a Recombinant Plant-Based Adjuvanted Covid-19 Vaccine

Sweden, Denmark pause Moderna COVID-19 vaccine for younger age groups
"The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated. Those conditions involve an inflammation of the heart or its lining."
commentary about this decision from Dr Dhand

Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
"Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes."

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting

Legal, Political, and Administration Issues with COVID 19 Vaccines-
Moderna COVID-19 vaccine patent dispute headed to court

Vaccine Inequity: Meet the Doctor Refusing a Booster as Rich Nations Get 16x More Doses Than Poor 

Kids COVID Vax Vote: Why the FDA's adviser Michael Kurilla Abstained | His important reasoning

FDA asks federal judge for 55 years to complete FOIA request for Pfizer vaccine information

Identifying and Tracking SARS-CoV-2 Variants — A Challenge and an Opportunity
"The emergence of worrisome variants of the SARS-CoV-2 virus has exposed the limited scale of surveillance efforts in the United States. More than 30 other countries conduct more sequencing of viral isolates than the United States does, thereby permitting greater understanding of the potential threat associated with various variants. To address this challenge, the Biden administration is planning to spend $1.75 billion included in the March 2021 American Rescue Plan on strengthening and expanding activities related to genomic sequencing, analytics, and disease surveillance and the workforce in these areas. This funding provides an opportunity to work toward establishing a more coherent and organized public health response system."

How Bill Gates Impeded Global Access to Covid Vaccines: Through his hallowed foundation, the world’s de facto public health czar has been a stalwart defender of monopoly medicine.
"The resulting document summarized the state of coronavirus research and proposed ways to accelerate the development of diagnostics, treatments, and vaccines. The underlying premise was that the world would unite against the virus. The global research community would maintain broad and open channels of communication, since collaboration and information-sharing minimize duplication and accelerate discovery. The group also drew up plans for global comparative trials overseen by the WHO, to assess the merits of treatments and vaccines."

 "When the Financial Times editorialized on March 27 that “the world has an overwhelming interest in ensuring [Covid-19 drugs and vaccines] will be universally and cheaply available,” the paper expressed what felt like a hardening conventional wisdom. This sense of possibility emboldened forces working to extend the cooperative model. Grounding their efforts was a plan, started in early March, to create a voluntary intellectual property pool inside the WHO. Instead of putting up proprietary walls around research and organizing it as a “race,” public and private actors would collect research and associated intellectual property in a global knowledge fund for the duration of the pandemic. The idea became real in late May with the launch of the WHO Covid-19 Technology Access Pool, or C-TAP."

“Things could have gone either way,” says Love, “but Gates wanted exclusive rights maintained. He acted fast to stop the push for sharing the knowledge needed to make the products—the know-how, the data, the cell lines, the tech transfer, the transparency that is critically important in a dozen ways. The pooling approach represented by C-TAP included all of that. Instead of backing those early discussions, he raced ahead and signaled support for business-as-usual on intellectual property by announcing the ACT-Accelerator in March.” 

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