A monkeypox vaccine distribution clinic will take place in Oakland Friday and Saturday.
The distribution will happen at The City of Refuge United Church of Christ on Enterprise Way starting at 11 a.m. ahead of the city's Pride parade and Pride-fest this weekend.
Organizers say the mission is to reach communities of color.
Research Highlights:
Embargoed until 4 a.m. CT/5 a.m. ET Monday, August 22, 2022
DALLAS, August 22, 2022 In a detailed analysis of nearly 43 million people, the risk of myocarditis in unvaccinated individuals after COVID-19 infection was at least 11 times higher compared to people who developed myocarditis after receiving a COVID-19 vaccine or booster dose, according to new research published today in theAmerican Heart Associations flagship, peer-reviewed journalCirculation. This analysis included data from Englands National Immunization database for people ages 13 and older who received at least one dose of a COVID-19 vaccine between December 1, 2020 and December 15, 2021 in England.
Several previous studies and reports from public health agencies around the world including the U.S. Centers for Disease Control and Prevention have highlighted a possible connection and potentially increased risk of myocarditis after receiving an mRNA COVID-19 vaccine, generating considerable scientific, policy and public interest .
Typically thought to be trigged by a viral infection, myocarditis is the inflammation of the heart muscle, the myocardium. This condition is uncommon and may temporarily or permanently weaken the heart muscle and the hearts electrical system, which keeps the heart beating normally. An episode of myocarditis may resolve on its own or with treatment, and may result in lasting damage to the heart. In the general population not during a global pandemic, it is estimated that approximately 10 to 20 people per 100,000 are diagnosed with myocarditis each year, according to the American Heart Associations 2021 scientific statement on myocarditis.
We found that across this large dataset, the entire COVID-19-vaccinated population of England during an important 12-month period of the pandemic when the COVID-19 vaccines first became available, the risk of myocarditis following COVID-19 vaccination was quite small compared to the risk of myocarditis after COVID-19 infection, says first author of the study Martina Patone, Ph.D., a statistician at the Nuffield Department of Primary Health Care Sciences at the University of Oxford in Oxford, England. This analysis provides important information that may help guide public health vaccine campaigns, particularly since COVID-19 vaccination has expanded in many parts of the world to include children as young as 6 months old.
In this study, Patone and colleagues evaluated Englands National Immunization database of COVID-19 vaccinations for all people ages 13 or older who had received at least one dose of the ChAdOx1 (a two-dose adenovirus-vector COVID-19 vaccine developed by the University of Oxford and AstraZeneca, most similar to the one-dose Johnson & Johnson/Janssen COVID-19 vaccine available in the U.S.), the Pfizer-BioNTech or the Moderna COVID-19 vaccine (the same mRNA vaccines available in the U.S.) between December 1, 2020 and December 15, 2021. This dataset totaled nearly 43 million people, which included more than 21 million who had received a booster dose of any of the COVID-19 vaccines (meaning they had received a total of 3 doses of a COVID-19 vaccine). The database detailed the type of COVID-19 vaccines received, dates received and dose sequencing, along with individual demographic information including age and sex for each individual. Nearly 6 million people tested positive for COVID-19 infection either before or after COVID-19 vaccination during the study period.
Englands National Immunization database records were then cross-referenced and matched to the national offices with data on COVID-19 infection, hospital admission and death certificates for the same time period, December 1, 2020 through December 15, 2021. Individuals were classified based on age and sex to reveal which groups had the highest risk of myocarditis after a COVID-19 vaccine or after COVID-19 infection and hospitalization. The authors used the self-controlled case series (SCCS) method, which was developed to estimate the relative incidence of an acute event in a pre-defined post-vaccination risk period (1-28 days), compared to other times (pre-vaccination or long after vaccination). Being a within-person comparison, the analyses were controlled to adjust for any fixed characteristics, including sex, race or ethnicity, or chronic health conditions.
In the overall dataset of nearly 43 million people, the analyses found:
Risk of COVID-19 vaccine-associated myocarditis among women:
Risk of COVID-19 infection-associated myocarditis among women:
Risk of COVID-19 vaccine-associated myocarditis among men:
Risk of COVID-19 infection-associated myocarditis among men:
It is important for the public to understand that myocarditis is rare, and the risk of developing myocarditis after a COVID-19 vaccine is also rare. This risk should be balanced against the benefits of the COVID-19 vaccines in preventing severe COVID-19 infection. It is also crucial to understand who is at a higher risk for myocarditis and which vaccine type is associated with increased myocarditis risk, said Professor Nicholas Mills, Ph.D., the Butler British Heart Foundation Chair of Cardiology at the University of Edinburgh and a co-author of the paper.
These findings are valuable to help inform recommendations on the type of COVID-19 vaccines available for younger people and may also help shape public health policy and strategy for COVID-19 vaccine boosters. The SARS-CoV-2 virus continues to shift, and more contagious variants arise; our hope is that this data may enable a more well-informed discussion on the risk of vaccine-associated myocarditis when considered in contrast to the net benefits of COVID-19 vaccination, said another co-author Julia Hippisley-Cox, F.R.C.P., professor of clinical epidemiology and general practice at the University of Oxford.
Authors noted there are two unanswered questions that likely require further investigation. The first is about myocarditis risk among children ages 13-17 because there were too few cases of myocarditis to quantify the risk specific to this age group. Secondly, researchers were not able to directly compare the death rate after COVID-19 infection vs. death after COVID-19 vaccination since the database only included people who had received at least one COVID-19 vaccine. More expansive data and a different analysis are still needed to address these questions and numerous other COVID-19 topics.
The study has two notable limitations. The number of cases of myocarditis among individuals who received a booster dose of the ChAdOx1 or Moderna vaccines was too small to calculate the risk of myocarditis. Additionally, researchers cannot exclude the possibility of over- or under-estimated risk due to misclassification of any health information in the database, though the U.K.s National Health Service is known to provide timely and accurate data.
Additional co-authors are Xue W. Mei, Ph.D.; Lahiru Handunnetthi, Ph.D.; Sharon Dixon, M.R.G.C.P.; Francesco Zaccardi, Ph.D.; Manu Shankar-Hari, Ph.D.; Peter Watkinson, M.D.; Kamlesh Khunti, F.R.G.C.P.; Anthony Harden, Ph.D.; Carol A.C. Coupland, Ph.D.; Keith M. Channon, M.D., F.R.C.P.; and Aziz Sheikh, M.D. Authors disclosures are listed in the manuscript.
The study received funding from an HDR-UK Research and Innovation grant, as well as support from the University of Oxfords COVID-19 Research Response Fund.
Studies published in the American Heart Associations scientific journals are peer-reviewed. The statements and conclusions in each manuscript and do not necessarily reflect the Associations policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. The Association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers and health insurance providers and the Associations overall financial information are available here.
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About the American Heart Association
The American Heart Association is a relentless force for a world of longer, healthier lives.We are dedicated to ensuring equitable health in all communities.Through collaboration with numerous organizations, and powered by millions of volunteers, we fund innovative research, advocate for the public's health and share lifesaving resources.The Dallas-based organization has been a leading source of health information for nearly a century.Connect with us onheart.org,Facebook,Twitteror by calling 1-800-AHA-USA1.
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The Corbevax vaccine was invented at the Center for Vaccine Development at Texas Children's Hospital and intended for countries that couldn't get access to more expensive COVID vaccines. India has inoculated millions of teens with Corbevax (above, a vaccination drive for children ages 12-14 at a school in Bangalore) and on August 10 authorized the vaccine as a booster for adults. Manjunath Kiran/AFP via Getty Images hide caption
The Corbevax vaccine was invented at the Center for Vaccine Development at Texas Children's Hospital and intended for countries that couldn't get access to more expensive COVID vaccines. India has inoculated millions of teens with Corbevax (above, a vaccination drive for children ages 12-14 at a school in Bangalore) and on August 10 authorized the vaccine as a booster for adults.
About This Series
Over the next week, we'll be looking back at some of our favorite Goats and Soda stories to see "whatever happened to ..."
Back in January, we told you about a different kind of COVID vaccine that had just been approved for use in India. The vaccine, called Corbevax, had some very attractive properties: It's low-cost, easy to make using well-established biotech processes and patent-free.
The vaccine's inventors were hoping it would help address questions of vaccine equity for countries that can't afford to make or buy expensive vaccines like the ones sold by Pfizer and Moderna.
It appears their strategy is working. Since Corbevax was authorized for use last December, Indian health authorities have administered quite a few doses. Here's where things stood on August 10 when I spoke with the two scientists who invented it: Peter Hotez and Maria Elena Botazzi, co-directors of the Center for Vaccine Development at Texas Children's Hospital.
"The new numbers as of this week from the Indian government say that 70 million doses have gone into arms," Hotez says. Those arms belong to adolescents, but on August 10 the vaccine was authorized for use as a booster in people 18 and older.
Not only does the experience so far suggest the vaccine confers long-lasting immunity, it also appears to be quite safe.
"We have not seen any pharmacovigilance that says otherwise," Botazzi says. Pharmacovigilance is the technical term for monitoring for bad side effects from a drug or vaccine.
In addition to using low-cost materials, Botazzi says they also wanted to be culturally sensitive. For example, they made sure no products derived from animals were needed to make the vaccine.
"Our technology is considered vegan and therefore we can develop this vaccine as a halal certified vaccine," she says an important consideration in countries with a large Islamic population like Indonesia.
It wasn't certain at first countries would take to Corbevax.
"A lot of people initially thought the global market for COVID vaccines is quite saturated," says Prashant Yadav, a senior fellow at the Center for Global Development. "Will there be a place for a late entrant, even if it comes at a lower cost and even if it comes with more open intellectual property?"
The answer to that question appears to be yes. In addition to a partnership with Biological E in India, a company called Biofarma in Indonesia is planning to make Corbevax.
And African countries are showing interest.
"Corbervax has been approved by the Botswana Medicines Regulator Authority," says Mogomatsi Matshaba, an adviser to the Botswana government on COVID-19 and executive director of Botswana-Baylor. He says Corbevax has not yet been used there, but he expects it will be, as well as in other African countries.
"The plan is to start mass production in Botswana," he says.
Of course lately, there have been new variants of the COVID virus, and it's not clear how well Corbevax will work against them. The Texas team that made Corbevax is trying to make a version of their vaccine that will work against all varieties of the virus.
At least one member of the U.S. Congress was so impressed with Hotez and Botazzi that she nominated the pair for the Nobel Peace Prize
"Their effort is to bring health, peace and security to all people by making it possible to vaccinate the world," says Lizzie Fletcher, a Texas Democrat. "So I think that that's very much in keeping with the purpose of the prize."
Dr. Peter Hotez and Dr. Maria Elena Bottazzi, co-directors of the Center for Vaccine Development at Texas Children's Hospital, developed Corbevax, a COVID-19 vaccine that they say is low-cost, easy to make, safe and effective. Max Trautner/Texas Children's Hospital hide caption
Dr. Peter Hotez and Dr. Maria Elena Bottazzi, co-directors of the Center for Vaccine Development at Texas Children's Hospital, developed Corbevax, a COVID-19 vaccine that they say is low-cost, easy to make, safe and effective.
Winning a Nobel prize is probably a long shot, but that's OK with Hotez.
"I'm on cloud nine and I think Dr. Bottazzi is as well in part because, you know, it's not just the recognition, it's the fact that we showed there's another way to do this," he says a way for a small, academically focused lab to make a vaccine that's safe, effective and affordable.
DNA Plasmid
A recent paper published by a team of scientists in Sweden boasts the ambitious title: A universal SARS-CoV DNA vaccine inducing highly cross-reactive neutralizing antibodies and T cells. This claim of a universal SARS-CoV vaccine would be good news if the paper measured up to its title. The study offers some interesting insights and may be of use for the creation of more broadly active SARS-CoV vaccines. However, the approach of this group of scientists seems hopeful if nothing else.
To understand the issue with their approach, lets take a step back. Current variations of the SARS-CoV vaccine rely on a singular feature of the virus: the spike protein. There are two widely accepted forms of these SARS-CoV vaccines. These are the adenovirus vector vaccine and the mRNA vaccine.
Both the adenovirus vector vaccine and the mRNA vaccine rely on introducing a slightly modified version of the spike protein to the body, causing the body to respond by creating antibodies against the spike protein.
These vaccines have proven to be highly effective at reducing serious illness and death across a wide variety of SARS-CoV variants. Unfortunately, the immunity they provide against infection and transmission is short-lived and seemingly depends on very high levels of antibodies. When the level of antibodies begins to fall or when a new spike protein variant appears and is unrecognizable to our antibodies, protection against infection quickly fades.
This means that there exists a need to create a vaccine that can protect the body from all SARS-CoV variants and that maintains high levels of antibodies. The research group from Sweden proposes to address this question in two different ways.
First, they include DNA from the most reactive portion of the spike protein in their new vaccine. This section of the spike protein is called the receptor binding domain (RBD). The receptor binding domain directly binds to the ACE2 protein on the cell surface and allows for viral entry and infection. By including three variations of these spike protein receptor binding domains, the researchers hoped to account for three common variants of the virus. These variants were the original Wuhan strain along with the Alpha and Beta variants.
Second, researchers also included DNA from two additional proteins that are highly conserved across the SARS-CoV variants. These are the membrane protein (M) and the nucleocapsid protein (N) from the original Wuhan strain of the virus. They coupled the M and N DNA with the spike protein receptor binding domain DNA into a single antigen. Both the M and N proteins have some broadly cross-reactive epitopes across strains of betacoronaviruses.
Figure 1: The universal vaccine contains the DNA of three spike protein receptor binding domains ... [+] (RBD) to account for three variants of SARS-CoV. The vaccine also contains additional membrane and nucleocapsid viral protein DNA.
Researchers believed this strategy would work because the receptor binding domain has previously been shown to naturally fold into its proper, functional configuration. Presumably, the M and N proteins would do the same.
To administer the vaccines, the researchers constructed the genetic material into a DNA plasmid with a promoter signal that would allow the DNA to be transcribed and translated into protein. They also optimized the codon usage of the receptor binding domain and the M and N proteins so that the proteins could be more easily expressed in human cells.
In their experiments, immunization took place via electroporation. Electroporation is a DNA vaccine delivery system that uses an electrical pulse to create temporary pores in cell membranes. This allows the DNA plasmid to pass through the cell membrane and into the cell. The cells could then use the DNA to form antibodies and induce an immune response.
After testing their vaccine on mice and rabbits, the researchers found that they were able to produce antibodies for the three spike protein variants and the N protein, but not the M protein. In mice, these antibodies were able to effectively neutralize the original Wuhan strain of the virus as well as the Beta variant of SARS-CoV-2. In rabbits, the antibodies effectively neutralized the Delta and Omicron variants of SARS-CoV-2.
When mice were tested with a lethal dosage of the SARS-CoV-2 Beta variant, the DNA vaccine fully protected the mice against lethal infection. After staining the mices organs to determine if viral infection spread throughout the body, researchers also found that the vaccine minimized viral replication in the upper airways and spleen.
While their results seem to be promising, there are still a number of questions as to whether this vaccine will translate to a universal vaccine against all SARS-CoV-2 variants. First, it is unclear whether or not the spike protein receptor binding domains along with the M and N proteins are sufficient to prevent reinfection.
The unmentioned challenge of creating a universal vaccine against SARS-CoV-2 is that reinfection occurs frequently. In other words, prior infection with all viral proteins including M and N does not provide long-lasting protection. Why do the authors assume that the antibodies that they include will perform any better than natural infection? Based on this observation, it is not evident that the addition of M and N antibodies would offer the protection that this team of researchers hopes for.
Whether or not a variety of spike protein receptor binding domains will offer broader protection against SARS-CoV-2 variants is also unclear. However, there is some hope of success for this theory, and it is currently being tested by several researchers in the field.
Another question is whether DNA-based vaccines are effective at all. Although there are a number of DNA vaccines in clinical trials, none have been approved by the United States FDA. In fact, only one has been given emergency-use authorization by India for Covid-19. It would also be interesting to know how broadly neutralizing this vaccine is against the newest variants that have been sweeping the world: BA.5 and BA.2.75
Overall, this study may contribute some insights into how we can create a universal vaccine, however, the title of the paper is highly misleading. Using a variety of spike protein receptor binding domains may offer broader protection against SARS-CoV-2 variants, but additional experiments on primates are necessary to determine whether this theory could hold in humans. While including more viral proteins in our vaccine strategy may seem like a solution, there is still much work to be done to understand how we can prevent reinfection before a universal vaccine is possible.
We will wait with interest and hope for the results of this DNA vaccine.
A new study is raising concerns about the effectiveness of the monkeypox vaccine being used in the United States and other parts of the world.
The work, which has not yet been peer-reviewed, found that two doses of the vaccine induced relatively low levels of neutralizing antibodies against the monkeypox virus, and those antibodies had poor neutralizing capacity.
The researchers noted the so-called correlates of protection what is needed, in terms of immune system weaponry, to be protected against monkeypox are not known. Still, the evidence of low levels of neutralizing antibodies raises questions about how much protection is generated by two doses of the vaccine, marketed as Jynneos in the U.S. and made by the Danish manufacturer Bavarian Nordic.
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At this moment it is unclear what the relatively low [monkeypox virus] neutralizing titers mean for protection against disease and transmissibility, the researchers, from Erasmus Medical Center in Rotterdam, the Netherlands, wrote.
But one of the senior authors of the paper said what is clear is that people being administered this vaccine ought to be cautious about assuming they are protected against infection.
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The expectation is not that this will provide sterilizing immunity, said Marion Koopmans, who heads Erasmus department of viroscience, referring to the type of immunity that will block infection.
Koopmans added that controlling the outbreak will require a suite of transmission-reducing tools, including isolation of cases, tracing and quarantining of contacts, and vaccination of people who have been exposed to the virus or are at high risk of exposure.
Inger Damon, who heads the division of high-consequence pathogens and pathology at the Centers of Disease Control and Prevention, said that studying how much protection the vaccine offers is critical, especially given that many of the people contracting it may be becoming infected via exposure of mucus membranes to infectious lesions. Mucus membranes are more delicate than skin, potentially allowing a larger dose of virus to infect an exposed individual.
I think this is something that we have to very carefully follow, and we need to really be very forthright in helping the community who is at risk to understand what the limitations of our knowledge is, Damon told STAT earlier this week in an interview.
On Friday, she said Koopmans had shared the data in the study with the CDC before it was posted online.
Foundational to all of this will be to understand the progression of disease and the immune response to disease with the different routes of infection that we believe we are seeing, Damon said in an email. This is complicated, and will require concerted, coordinated, and collaborative efforts to find the right solutions to stop the spread of disease. Good health communications, and effective harm reduction messages are going to be integral.
The Erasmus study suggests, among other things, that a one-dose regimen seems to be inadequate to induce protection.
The second vaccination is important for reaching detectable antibody levels, as individuals in a single-shot regimen hardly developed antibody responses four and eight weeks after vaccination, the researchers wrote.
The study also casts a shadow over the recent decision by the U.S. government and others to stretch vaccine supplies by giving people one-fifth of a regular dose and to do so by intradermal (into the skin) rather than subcutaneous (under the skin) injection. Intradermal administration, which requires smaller doses to be protective, has been shown to be effective in other disease outbreaks with other types of vaccine.
The decision to use this dose-sparing approach which allows up to five people to be vaccinated with the amount of vaccine normally used for one was largely based on a small study that compared immune responses generated by two fractional doses given intradermally to two full doses given subcutaneously. They were deemed to be comparable.
But Koopmans and her colleagues saw another result in an earlier Erasmus study that tested fractional doses of a bird flu vaccine using the same vaccine backbone as the Bavarian Nordic product.
Jynneos uses a modified vaccinia virus called MVA, the same attenuated virus formerly used to vaccinate against the now-eradicated smallpox to teach the immune system to be on guard for monkeypox, a related virus.
The same MVA backbone was used in an experimental vaccine to protect against H5N1 bird flu. There, the two fractional doses generated lower amounts of antibodies than the full doses did, the researchers reported.
This same trial indicates that dose-sparing has a negative effect on the serological outcome of vaccination, they wrote.
It should be noted that in that trial, the fractional doses were administered by intramuscular injections, not intradermal. Koopmans said the group is planning to test whether intradermal vaccine administration would improve results, once it has been cleared to conduct the study.
Asked if she thought public health authorities should rethink giving fractional doses of monkeypox vaccine, she wrote: I think it requires testing.
So does Michael Osterholm, director of the University of Minnesotas Center for Infectious Diseases Research and Policy. Osterholm thought the move to fractional dosing was made too quickly, based on too little data.
I realize in a public health crisis, sometimes you have to make decisions with imperfect information, he said after reading the Erasmus study. But this is the kind of data that I think everyone needs to take a step back now and say: What does this mean for what were doing right now?
They dont have a lot of other tools, he acknowledged. But at the same time, if the tool youre using isnt adequate to do the job, then you have to consider that. Do we need to go back to full dose?
Osterholm and others expressed concern that people getting the vaccine will conclude they have a level of protection that they may not have.
Second doses will be available by appointment only at least 10 weeks after receiving their first doses
City will also open eligibility to sex workers, and those forced to engage in survival sex, and begin accepting walk-ins for first doses at City-run sites on Friday, September 2nd, though appointments are still recommended by going to at vax4nyc.nyc.gov/monkeypox and by calling 877-VAX-4NYC (877-829-4692)
8,000 new first dose appointments open to public at 4 p.m. on Friday, September 2
September 1, 2022 New York City has announced that it will begin making second doses of the monkeypox vaccine available by appointment only. People who received their first dose at least 10 weeks earlier will be notified by email or text that they are eligible for their second doses so that they can make appointments online or by phone. Second doses will only be available at least 10 weeks after the first dose and not earlier. The City will also begin welcoming walk-ins for first doses at City-run sites, though making an appointment in advance is still recommended, and there will be 8,000 public appointments available for reservation on Friday, September 2 at 4 p.m. The citys Vaxfinder will indicate which sites offer walk-ins. In addition, to reach more New Yorkers who may be at-risk, the city will expand eligibility to people engaged in sex work.
While our strategies have been constrained by scarcity, our goals have always been expansive, and that is to get vaccine to New Yorkers who need it, including second doses, said Health Commissioner Dr. Ashwin Vasan. Now that weve gotten first doses to more than 70,000 New Yorkers, people can get their eagerly awaited second shots by appointment and were making vaccination even more convenient by welcoming walk-ins for first doses.
On July 15, the city announced a first dose strategy to offer protection to as many New Yorkers as possible and to help stop the spread given the extremely constrained vaccine supply. A 28-day interval between doses is indicated in the FDA prescribing label. There is no concern about the immune response to the vaccine by waiting 10 weeks. Second doses will be provided at 10 weeks to ensure adequate supply and capacity for administration of vaccines to all eligible New Yorkers who need their first and second doses.
The City will continue to work with community-based organizations serving New Yorkers at higher risk to offer direct referrals for their clients.
Eligibility has so far been limited to people who meet all of the following conditions:
Starting immediately, New York City will now open eligibility to sex workers and anyone engaging in survival sex or any other type of transactional sex (e.g., sex in exchange for shelter, food, money, and other goods) of any sexual orientation or gender identity.
It is crucial to seek care as soon as a rash or sore is identified. New Yorkers should call their health care provider immediately. For those who do not have one, they can call 311 to get connected to an NYC Health + Hospitals location or to access H+H Virtual Express Care. New Yorkers can also visit the NYC Health Map to find a nearby provider. Care is available in New York City regardless of immigration status, insurance coverage, or ability to pay.
For more on MPV, visit our Monkeypox page.
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MEDIA CONTACT: Patrick Gallahue/Victoria Merlino, pressoffice@health.nyc.gov
JaBaris Swain paced a gymnasium at a monkeypox vaccination clinic this week, weighing whether he had enough shots to meet the need in a vulnerable community in North Philadelphia.
Forty-seven people already had come in for their first shot of a two-dose vaccine thats been in short supply in an outbreak that is significantly impacting Black men who have sex with other men.
With at least five more appointments scheduled, Swain would not be able to vaccinate all and guarantee second shots, too. He still decided to tap into supplies intended to be held back for second doses.
If you look at it from a utilitarian perspective, you make sure that the most people have at least one line of protection, said Swain, medical director at the Dr. Ala Stanford Center for Health Equity.
More than half of Philadelphias monkeypox cases have been reported in Black residents, but they have received just 24% of the vaccine doses. White residents have received 56% of shots, and account for 24% of infections.
Monkeypox can spread through close physical contact. Although the current national outbreak is mostly infecting men who have sex with men, cases also have been reported in women and children. Wednesdays clinic was among the first in Philadelphia hosted in a predominantly Black neighborhood in response to the current outbreak.
READ MORE: Black Philadelphians are at higher risk of monkeypox but get just a fraction of vaccine doses
Similar disparities occurred during the COVID-19 pandemic, which took the heaviest toll on Black Philadelphians. But the initial vaccine rollout saw more white residents getting shots. Black residents continue to have lower vaccination rates.
Advocates say outreach has been lacking in the neighborhoods where many at-risk Philadelphians live. Expanded effort is needed, said Elle Lett, who established Philly MPX Action with a small group of health professionals to do outreach around the virus.
We need to have vaccine clinics in Kensington, North Philly, the Northeast, in Southwest Philadelphia, said Lett, a medical student and social epidemiologist at the University of Pennsylvania, who is a Black trans woman. Philly is a very queer-person-of-color city.
City health officials said their efforts have been hindered by a lack of federal funding that was anticipated when monkeypox was declared a health emergency last month.
The health department said on Thursday it was seeking local applicants for 10 grants of $50,000 or $25,000 to improve access and outreach. The health department is drawing on $375,000 from its budget to fund the grants, hoping to eventually be reimbursed with federal money.
Community partners can play an important role in closing the vaccination equity gap, according to the health department, and the grants are intended to kick-start the effort.
Vaccine is currently available at Bebashi -- Transition to Hope, a health provider focused on people with HIV, health officials noted. Black patients have received the majority of their doses, said Nackea Bachman, a physicians assistant who is involved in the providers weekly vaccination clinics held on Thursdays at the centers building near 13th and Spring Garden Streets.
The health department is also working with Philly Pride to reach gay Black men and has plans for clinics in West Philadelphia through September with Action Wellness, a health center for people with HIV and other chronic illnesses.
Fewer new monkeypox cases have been reported in Philadelphia in recent weeks, according to data maintained by the Philadelphia Department of Public Health, but city officials say its too soon to determine whether the outbreaks spread is coming under control. There have been 327 cases of the virus reported so far in Philadelphia.
About 53% of doses administered at the Ala Stanford health centers pop-up clinic on Monday and Wednesday went to Black patients, according to the clinics medical director.
Staff there is careful to protect the anonymity of the people going there for monkeypox vaccine doses. One factor complicating the monkeypox vaccination effort is that some men who have sex with men may be less likely to identify as gay, experts note, and they could be averse to visiting a clinic established specifically for monkeypox vaccine.
We are being discreet, " said Doris Cush, director of nursing. Its total anonymity.
The clinic is working to reach deeply into the local LGBTQ community. For example, it is coordinating with a party planner to share vaccination information at an alternative lifestyle party this weekend.
A local resident who was vaccinated this week, Sarah Craig, said getting a shot there added to their comfort.
Theyre very friendly and informative here, said Craig, who is Black and nonbinary. They wanted to get vaccinated because working as an acupuncturist involves close contact with other people.
READ MORE: Philly sex workers finally have access to the monkeypox vaccine
But supplies are still tight in Philadelphia. Federal authorities allocating the vaccines had suggested the new strategy could yield up to five doses from each vaccine vial, but Cush said she has struggled to get more than four. The city health department said three to four doses per vial is typical.
By Wednesday afternoon, Swain learned that he could order more vaccine, though he wasnt sure when, and decided to dip into the second dose supply to give shots to every person with an appointment.
Later Wednesday, he received confirmation that the health center would receive 200 more doses.
If supplies hold up, he plans to host monkeypox vaccination clinics at least weekly at the center. Just this week, shots went to gay men, transgender women, and sex workers, most of them Black.
We have to keep reminding the city, there are pockets of the city that dont have access, he said.
The human papillomavirus (HPV) belongs to the Papillomaviridiae family and is a DNA virus most commonly implicated in causing sexually transmitted diseases. Until now, more than 40 HPV subtypes have been isolated that have the potential to cause infection in the genital areas of both genders. Different subtypes of the human papillomavirus affect different areas of our body. But among all the subtypes, a total of only 15 human papillomavirus subtypes are related to the development of cervical cancer. Among the subtypes causing cervical cancer, the HPV 16 genotype accounts for the causative organism in 70% of cases [1].
The contribution of risk factors like alcohol consumption, cigarette smoking, exposure to the sun, and other radiation for a prolonged period to the causation of cancer is well-documented. But the general public is less aware that a significant amount of the world's cancer burden is linked to infectious diseases [2]. Epidemiological studies suggest that socioeconomic factors like education and income, sexual and reproductive factors, and other lifestyle factors and specific health behaviours mentioned above contribute to the development of cervical cancer [3]. HPV 16, which belongs to the high-risk HPV group, is a major risk factor in developing invasive cervical cancer. Therefore, there could be a significant decrease in the incidence of cervical cancer by preventing persistent HPV infection. This can be achieved through health care promotion, education, and counselling about safe sexual practices, delaying first intercourse, male circumcision, and early diagnosis and treatment of any vaginal infection [4].
The incidence of cervical cancer is highest among 50-to 55-year-old females, and the highest mortality is seen in females aged 75 years and over. This suggests that there is a slow progression of cancer after acquiring an infection at a younger age [5]. Low socioeconomic status is among the important risk factors for developing cervical cancer. This is reflected by the fact that around 85% of all cervical cancer cases are reported in underdeveloped countries [4]. India, where 16-17 per cent of the world's women live, is home to 27 per cent of all cervical cancer incidences worldwide [6]. Among India's 60,000 annual deaths, nearly 33 per cent of all cervical cancer deaths worldwide are attributed to India, along with 100,000 newly diagnosed cases [7]. According to Globocan 2020, there were 6,04,100 new cases found worldwide in 2020, and cervical cancer was responsible for 341,831 deaths, as shown in Figure1 and Figure 2.
In 2020, cervical cancer accounted for 18.3 per cent (123,907) and 9.4 per cent of all cancer cases in India. It is one of the more prevalent malignancies in India and is the main factor in the death rate from cancer among women in underdeveloped nations [8,9]. Therefore, cancer prevention techniques are required to lessen financial strain and human suffering. In addition to being a part of tertiary prevention for cancer patients who have already had curative therapy to prevent a recurrence, vaccinations are a part of primary prevention to lower the incidence of premalignant and malignant cancer [10]. A target for eliminating cervical cancer globally has been set by the World Health Organization (WHO), which is defined as having an annual incidence of less than 4 per 100,000 women [11]. Three crucial pillars and their accompanying goals are necessary to achieve that target. They are:
Vaccination - 90% of girls are fully vaccinated with the HPV vaccine by the age of 15; Screening: 70% of women are screened using a high-performance test by the age of 35 and again by the age of 45; Treatment: 90% of women with pre-cancer are treated, and 90% of women with invasive cancer are managed.
Reaching the 90-70-90 target by 2030 will put each country on the path to eradicating cervical cancer within the next century [12].
The National Cancer Control Programme (NCCP) was established in 1975 to provide the best cancer hospitals and institutes with the appropriate equipment to treat the disease. The national programme was altered in 1984, with a greater emphasis placed on the primary prevention of disease occurrence and early cancer case identification. The agenda was further expanded in particular districts with medical college hospitals from 1990-1991 and the District Cancer Control Programme was launched. In the 2000s, it experienced additional alterations. The National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Illnesses, and Stroke (NPCDCS) project, initiated in 2010 to prevent and control serious non-communicable diseases, now includes cancer control [13].
A)Vaccination as a Tool to Prevent Cancer
In India, asymptomatic female screening is seldom done. Hence, immunisation against HPV is a promising method of preventing cervical cancer. Both HPV vaccines, Cervarix and Gardasil, are equally effective against recurrent HPV 16 and 18 infections [4]. HPV vaccination offers primary prevention against HPV types 16 and 18 [14,15]. The dissemination of the vaccine to underdeveloped nations has been uneven, even though vaccination with Cervarix and now, Gardasil, has demonstrated its effectiveness in the immunoprevention of cervical cancer. Vaccine uptake has encountered several difficulties, even in nations where the vaccine is widely available [16].
B)Vaccines Available in India
Since 2007, four prophylactic vaccines, namely, Gardasil, Cervarix, Gardasil 9, and Cecolin, have been approved for use against HPV infection. As shown in Table 1, the number of HPV strains each vaccine is designed to prevent varies. As a result, not all HPV-related cancers can be avoided by the current vaccines [2].
The first commercially available vaccinations to prevent HPV infection were Cervarix, a bivalent HPV vaccine that protects against two subtypes of HPV, and Gardasil, a quadrivalent HPV vaccine that targets four subtypes of HPV, as given in the above table. The Gardasil 9 vaccine, commonly known as the nonavalent HPV vaccine, provides defence against both high-risk and low-risk HPV strains [18]. The vaccines provide long-term protection against primary HPV vaccine-type infection and a minimal level of cross-protection, and they seem to be safe [19]. The HPV vaccine is crucial for public health. In India, there is little compliance with cervical Pap smear screening. The vaccines that are currently available are reliable and effective. The HPV vaccine is now widely accepted and a part of immunisation programmes in many nations. The vaccine should be given before the first sexual encounter because protection occurs only when given before HPV infection. Ideally, parents should first learn about the vaccine as a cervical cancer prevention vaccine rather than a sexually transmitted disease vaccine [20].
C)Vaccine Dose and Schedule
The 0.5 mL intramuscular dose, which can be given in either the anterolateral thigh or deltoid muscle, is available as a single-dose vial of sterile suspension for injection or as a prefilled syringe, both of which need to be thoroughly shaken before use. It is important to adhere to the manufacturer's recommendations for vaccine storage and administration [21]. The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) concluded that the mounting scientific evidence shows single-dose schedules are just as effective as two- or three-dose regimens. The vaccine offers reliable protection against HPV, the virus that causes cancer of the cervix, and is comparable to 2-dose schedules, according to SAGE's evaluation.
SAGE suggests changing HPV dosage schedules as follows: One or two doses for the primary target of girls aged 9-14; one or two doses for young women aged 15-20; two doses separated by six months for women over the age of 21.If possible, immunocompromised people, including those with HIV, should receive three doses; if not, they should receive at least two doses [22].The first dose must be given between 9 and 12 years of age and should be completed before 26 years of age. The hepatitis B and tetanus, diphtheria, and pertussis (Tdap) vaccines can be administered alongside the HPV vaccine [23,24].
D) The Mechanism of Vaccine Action
Given that HPV exclusively affects humans, it is difficult to determine how the nonavalent HPV vaccination works. However, it is thought that the humoral response is what causes the vaccination to work. Nonavalent HPV vaccines are created using the L1 virus-like particles (VLP) of the carcinogenic protein subunit(CPS) component of the HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. According to 2016 immunogenicity research, the vaccine's inactive HPV L1 virus-like particles (VLPs) generate antibodies that neutralise diverse HPV strains and trigger a potent humoral immune response that protects against illnesses and dysplastic lesions brought on by HPV. According to the same study, the nonavalent HPV vaccine raised antibody titers that are 10-100 times higher than those brought on by naturally occurring infection. The effectiveness of the vaccine, therefore, seems to be mediated by humoral response mechanisms [25].
For nations like India, which have a high disease burden, HPV vaccinations can be a game-changer for cancer prevention. According to the WHO's position paper on the subject, the vaccine must be integrated into national immunisation programmes worldwide [21]. Despite the benefits of HPV vaccination, herd immunity cannot be achieved globally due to the current level of vaccine uptake. Models indicate that eliminating HPV infections will require worldwide vaccination rates of 80% to achieve the WHO Cervical Cancer Elimination Strategy's goal of promoting HPV vaccination to 90% of all adolescent girls by 2030 [2]. However, the average completion rates for all WHO areas in 2020 ranged from 29% to 60% [26].
A) Health Priorities and Vaccine Cost
Although the development of HPV vaccines has raised expectations for the future elimination of cervical cancer, the inclusion of HPV vaccination in India's immunisation programme has been hotly contested. The government's programme's inclusion of the HPV vaccine may not be at the top of the list of health priorities for India. Given that the public sector's spending on health is extremely high, without assistance from outside, it is challenging for the Indian government to incorporate a costly vaccine into the country's national vaccination programme [27].
B) Epidemiological Evidence on Cervical Cancer
Various Indian regions are underrepresented in data from overlapping sources such as the National Cancer Registry Programme (NCPR) reports, Cancer Atlas, C15, and Globocan cancer data [28]. According to a recent analysis of cancer epidemiology in India, cervical cancer, which has a burden of 17.1 per cent among females aged 30-69, is the most prevalent deadly malignancy [29]. According to another study, the age-adjusted mortality rate for cervical cancer was 7.7 per 100,000 [28]. According to earlier research, the death rate in rural areas is approximately 65.5 [30]. The epidemiological statistics from India regarding HPV and cervical cancer are inconsistent. Due to the wide range of estimates for the illness burden, which ranges from a low of 7.7 to a high of 65.5, policymakers confront significant hurdles in measuring the real disease burden for the implementation of the cervical cancer vaccination programme [4].
C) Vaccine Acceptance
According to a survey, 72% of educated urban males and females in the middle or upper socioeconomic levels who had at least one girl child had never heard of HPV. After reading a brief information sheet regarding the HPV vaccine, 80% of parents stated they would vaccinate their daughters, even though only 46% of parents intended to protect their girls against STIs [31].
D) Vaccines and Cervical Cancer Screening
Vaccination against HPV is as important as cervical cancer screening. There are several obstacles to overcome to effectively employ the vaccine to control this totally avoidable disease. These include lowering vaccine costs, receiving government and policymaker support, educating at all levels, and removing immunisation barriers. The ideal plan for prevention should include the immunisation of teenagers before the onset of sexual activity and screening for and treating precancerous lesions, a surrogate marker for cervical cancer [4].
A)Raising Public Awareness
It is important to promote the integration of cancer prevention and education into every parent and caregiver's routine and to develop a plan for the long-term monitoring of girls who have received the vaccine. It is necessary to identify the gaps and hurdles to access and delivery of HPV vaccination. The best way to influence and increase public awareness is through communication. It is crucial to inform parents and caregivers about the cervical cancer vaccine and to develop uplifting, intelligible messages that the public and the media can recognise as their own. The government's spending on cancer treatment facilities in India is very high; this, in turn, has a positive economic impact [20].
B)Impact of Education
The findings of the study showed that parents had a limited grasp of the health issues linked to HPV infection, its prevention, and modes of transmission. The HPV vaccine is readily available, and the value of taking precautions and its advantages in preventing cancer was unknown to nearly half the subject population. However, 43.75% of the respondents said they would be open to receiving an HPV vaccination. The study's findings indicated a substantial knowledge gap between before and after the intervention, but there was no appreciable change in perception. Although there is a minimally discernible change in awareness, a constructive behavioural change was seen in favour of vaccination, which might eventually influence the subject's perception. Our study and other outreach initiatives would be crucial in reducing the prevalence of genital cancer worldwide. The research even suggested that school can be a good place to educate and communicate with teenage females about getting vaccinated against HPV [32].
C)Measuring Behavioural and Social Drivers of Vaccination
The WHO formed the "Measuring Behavioural and Social Drivers of Vaccination" (BeSD) working group in 2018 to better identify the factors that influence vaccine coverage. A team of global health specialists created the BeSD framework to collect and utilise information on the behavioural and social factors that influence vaccination. The framework comprises four areas that can be changed to influence vaccine uptake [33-36]. They are practical issues, motivation, social processes, and thoughts and feelings.
Given the wide range and seriousness of illnesses brought on by infection, addressing HPV and its associated pathologies will remain a top priority in public health. Despite the advancement of immunisation for illness prevention, there is still a sizable worldwide burden from these disorders. Many benign and malignant diseases, as well as HPV infection, are possible outcomes. The HPV vaccine's untapped potential to reduce cancer risks, costs, and psychological suffering stands out, as it is the only vaccine that can prevent cancer. In order to provide effective cervical cancer screening programmes and community-level activities to increase community engagement and knowledge about cervical cancer, India must strengthen the capacity of its health system. This can only be accomplished by training a workforce of paramedical and health professionals who are informed about screening. Partnerships must be made with international businesses that make vaccines, diagnostic devices, and cancer therapies in the private sector as part of an immediate, coordinated effort. This is necessary to enable efficient intervention and stop the almost 350,000 deaths from cervical cancer predicted for 2021 and beyond. Vaccination programmes are still being developed and expanded, but public acceptance of vaccination still faces cultural hurdles, necessitating public awareness campaigns to increase vaccination compliance. Despite obstacles to worldwide vaccine distribution, the vaccine's effectiveness and effects on global public health should not be understated. Ongoing efforts are required to optimise the vaccine's benefits for the individual and the entire population. Once these objectives are met, cancer immunoprevention through vaccination will become the norm for long-term cancer treatment.
Sep 03, 2022 9:17 2 min read (Updated: Sep 03, 2022 9:18)
A Covid vaccine being developed by the Federal University of Minas Gerais and the Oswaldo Cruz Foundation, a federal biological institute, may be ready for testing in humans next year. Development of the SpiN-TEC immunizer began in March 2020 and is supported by the Brazilian Science and Technology Ministry.
Researchers say the vaccine has shown promising results in lab and animal trials. The next step, testing on humans, is expected to begin in 2023 but still needs authorization from federal health regulator Anvisa.
Experimental vaccines administered to animals proved to be effective in diminishing the effects of Covid on organisms. During animal trials, the researchers used a two-jab scheme, separated by a 21-day interval. In human trials, they will evaluate if one dose is enough.
The SpiN-TEC vaccine is reportedly made up of proteins S and N which would offer it an advantage over other vaccines that only contain protein S. According to Natlia Salazar, a researcher at CTVacinas (the vaccine development center at the Oswaldo Cruz Foundation), this technology has been used against parasitic diseases such as leishmaniasis and Chagas.
SpiN-TEC, however, is many months away from being rolled out to the general public. And over 79 percent of Brazilians have already completed their first vaccination scheme, with 47 percent already receiving booster shots.
Still, researchers expect the Brazilian-made vaccine to prove useful against possible new variants.
Treatment with AST-301 will be explored in patients with HER2-low breast cancer in the phase 2 Cornerstone-011 study.
Treatment with the novel HER2-hICD vaccine, AST-301, will be assessed in patients with HER2-low breast cancer in the phase 2 Cornerstone-001 trial (NCT05163223) following the FDAs clearance of an investigational new drug application.1
According to an announcement by Aston Sci. Inc., the launch of FDA clearance and the launch of the study comes after the approval of the agent in Australia and Taiwan.
"It is a remarkable milestone that is definitely a leap forward for us in the cancer vaccine clinical development field. Based on the significant regulatory value of the phase 1 clinical trial, including more than 10 years of long-term survival data, we have reinforced regulatory-required data which complies to the latest guidelines of therapeutic cancer vaccine, and the United States FDA has fully reviewed and approved it, said the regulatory affairs director of Aston Sci. Inc., in a press release.
Cornerstone-001 is a placebo-controlled, randomized study designed to evaluate the efficacy and safety of AST-301 in patients with HER2-low breast cancer that is hormone-receptor negative and who have residual disease after neoadjuvant therapy.
Patients in the study will be randomly assigned 1:1 to receive either AST-301 with recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM CSF) and standard adjuvant therapy in the experimental arm or placebo with rhuGM CSF and standard adjuvant therapy in the control arm.1,2
Standard adjuvant therapy consists of pembrolizumab (Keytruda) and capecitabine. Adjuvant therapy in the study will be given 3 times every 3 weeks with a booster at 24 weeks in accordance with the guideline recommendations. AST-301 and rhuGM CSF will also be administered every 3 weeks for 3 cycles with a booster at week 24.
The primary end point being assessed in the study is 2-year invasive disease-free survival. The secondary end points include AST-301-specific T-cell immune response, change in central memory T-cell populations, distant recurrence-free survival, and the number of patients with treatment-related adverse events.2
The eligibility requirements for the study state that patients must have residual invasive disease that is stage I-III, HER2-low expression without gene amplification, an ECOG performance status of 0 or 1, and adequate organ function. Patients are excluded from the study is they have a history of hypersensitivity to rhuGM CSFm, history of invasive malignancy with 5 years before first administration of investigational study treatment, history of autoimmune disease or inflammatory disease, active infection, or pregnancy. The study also excludes those who are receiving immune suppression therapy or have within 4 weeks before the first administration of investigation study treatment.
REFERENCES:
1. Aston Sci. receives IND approval from U.S. FDA for phase 2 clinical trial of the therapeutic cancer vaccine AST-301 in patients with HER2 1+/2+ breast cancer. News release. Aston Sci., Inc. September 1, 2022. Accessed September 2, 2022. https://bit.ly/3CNjodI
2. Therapeutic cancer vaccine (ast-301, pngvl3-hicd) in patients with breast cancer (Cornerstone001). ClinicalTrials.gov. Updated May 5, 2022. Accessed September 2, 2022. https://clinicaltrials.gov/ct2/show/NCT05163223
