Researchers around the world have been racing to develop new vaccines, antivirals, and other therapies to blunt SARS-CoV-2s attack, even while the virus evolves to become an endemic problem.
While existing vaccines are capable of reducing severe cases of COVID-19, at least with a recent booster, continued mutations and the difficulty of maintaining high booster rates mean that better defenses will need to be developed.
Vaccines are making a huge difference, but vaccines are not universal, and there is still a tremendous need for other approaches, Anders Nr, a professor of metabolic biology at UC Berkeley, said.
While existing vaccines are capable of reducing severe cases of COVID-19, continued mutations and the difficulty of maintaining high booster rates mean that other defenses will need to be developed.
Nr and his Cal colleagues approach uses inhalable, DNA-like molecules to throw a wrench into the coronaviruss replication machine.
A nasal spray that is cheaply available everywhere and that could prevent someone from getting infected or prevent serious disease could be immensely helpful, Nr said.
Gumming up the works: The Berkeley teams nasal spray, published in Nature Communications, uses short snippets of synthetic DNA called antisense oligonucleotides or ASOs for short.
ASOs can be programmed to glom onto specific strings of RNA blocking them from being copied or turned into proteins.
Nr has been studying the use of ASOs for over a decade, trying to figure out how to use them to affect RNA involved in conditions like type 2 diabetes, Duchenne muscular dystrophy, and fatty liver disease.
But when the pandemic hit, they set their sights on a different type of RNA virus RNA.
The SARS-CoV-2 genome is single-stranded RNA, similar to messenger RNA or microRNA, Nr said. We thought perhaps we could use these ASOs to stick onto the viral RNA and prevent it from working.
The nasal spray uses DNA-like molecules to gum up SARS-CoV-2s replication.
The hairpin bend: Working with the Innovative Genomics Institute and Berkeley researcher Sarah Stanleys lab, the team sicced hundreds of different ASOs all designed to attack different parts of the genome on SARS-CoV-2.
One target in particular proved effective: a non-coding portion of the virus RNA that forms a hairpin and seems to play a key role in replication. With an ASO stuck to its hairpin, the virus was unable to replicate.
The ASOs stopped the coronavirus from replicating in human cells in the lab, and in animal experiments, it both prevented infection, when given early, and treated COVID-19 after infection.
We showed that if you bind an ASO to this hairpin, it dissolves the hairpin, and the RNA forms a straight line instead of a bubble structure, Nr said. We think that this prevents the virus from effectively translating and replicating, and we found that it was incredibly effective at preventing viral replication in human cells.
When sprayed in the noses of mice and hamsters, the ASO protected against and treated COVID-19, but just as importantly, it did not spark an immune response of its own suggesting it likely wont cause toxic side effects in people.
The hairpin is found in all known variants of SARS-CoV-2, and the teams ASOs were shown to be effective against variants of concern, including Delta and Omicron.
A nasal spray that is cheaply available everywhere and that could prevent someone from getting infected or prevent serious disease could be immensely helpful.
Next steps: ASOs are stable and relatively cheap to produce at scale, the researchers said, making them a potential boon for fighting the virus around the world.
Theyre also a promising way to attack other RNA viruses, like influenza, RSV, and other respiratory viruses, since they can be designed to stick to any RNA genome. The team has already found an ASO which sticks to a target in SARS-1, and they have begun preliminary work on influenza.
More research will be required before human clinical trials can begin, though.
Its very clear that this virus is not going away, Nr said. We need a lot of different avenues to tackle it, and therapeutics like ours that are agnostic to the variants could play a major role.
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(NEXSTAR) In case we didnt have enough viruses to worry about, reports of a tomato flu outbreak in India started to surface this month. The virus, named for the bursting red blisters it causes, has infected at least 100 children.
The virus was first identified in Kerala in May, where it infected 82 children all under the age of 5 by the end of July, according to The Lancet medical journal. At least 26 more cases were also confirmed in neighboring states of India.
The most common symptoms appear to be fever, joint pain and the rash that gives the virus its new nickname. Tomato flu gained its name on the basis of the eruption of red and painful blisters throughout the body that gradually enlarge to the size of a tomato, The Lancet reported.
News outlets started to report on the disease as a new virus, but new testing out of the United Kingdom seems to indicate the tomato flu isnt new at all nor is it a type of flu.
Viral swabs were taken from two children who had recently returned from India showing the bright red rash, reports the British medical journal BMJ. The test came back positive for Coxsackie A16, a pathogen commonly associated with Hand, Foot, and Mouth Disease (or HFMD).
According to the Centers for Disease Control and Prevention, HFMD is very common among children, even here in the United States, because of how contagious it is. The symptoms including fever, mouth sores and skin rashes last seven to 10 days for most kids.
When there is a rash with HFMD, the rash usually is not itchy and looks like flat or slightly raised red spots, sometimes with blisters that have an area of redness at their base, says the CDC.
This common disease may have been initially mistaken as a new tomato flu virus because the blisters observed in India were larger.
Doctors in Kerala told BMJ that even in the cases they have seen over the past few months, they have yet to admit any children to the hospital. All of the patients have recovered on their own thus far.
DENVER New COVID-19 boosters that target the most prominent omicron strains of the novel coronavirus currently spreading throughout the country will soon be available in Colorado.
While the current vaccines still offer strong protection against hospitalization and death, immunity against infection has dropped significantly as more immune evasive variants have emerged over the course of the pandemic.
The arrival of the BA.4/5 COVID-19 boosters is good news for those looking for added protection, but how much of it they will create remains to be seen.
Denver7 spoke with Heather Roth, the Colorado Department of Public Health and Environment's immunization branch chief, to talk about their efficacy, how they were approved, what the new boosters mean for families looking to vaccinate their kids as we enter a new school year, and more.
Please note: This interview has been edited for time and clarity.
1. The CDC has approved the bivalent COVID-19 BA.4/5 boosters, meaning the vaccine has components from the wild type strain (the original Wuhan strain of the novel coronavirus) and the BA.4/5 sublineages of the omicron variant.
What do we know about the efficacy of these boosters against severe disease, and, more importantly, against transmission and infection, given that no human neutralization data was submitted and only mice data was used, as it is done with the flu vaccine each year?
I think the important thing to know is that the updated vaccines were developed and manufactured using the same process as the original vaccines, except that they now contain a second component, right? And that is a component targeting the omicron BA.4 and BA.5 subvariants.
In kind of reviewing the data in making this decision, both the FDA and CDC looked at the safety and effectiveness data from the original mRNA vaccines that have been administered to hundreds of millions of people in the U.S. alone. They also looked at safety and immune response from the bivalent booster studies of about 1,400 people that included the original strain and what had been the BA.1 variant. And then, as you mentioned, data from a study of the new omicron vaccines in mice. Based on all of that kind of taken together, the vaccines are expected to increase protection against the currently circulating omicron BA.4/BA.5 subvariants.
2. Many people skeptical of COVID-19 vaccines and the virus itself will say its just a cold or its just a flu. First of all, is COVID-19 the same as the flu?
No, they're obviously two different viruses and they cause different severe effects if you end up getting sick.
There's no such thing as long flu but there is such a thing as long COVID, right? There are two separate things and they're both quite real, and we're heading into the fall; they're both going to be circulating at the same time.
3. Knowing that COVID is not the same as the flu, should it concern people that the CDC is applying a flu-like approach to these boosters before humantrial data is complete? After all, flu shots typically arent very effectiveso wouldnt we want to know how effective these COVID boosters are going to be before rolling them out?
I think comparing development of flu vaccines to really any other vaccine is like comparing apples to oranges. The science the data that kind of the guessing game that goes behind flu vaccine development is very different than what we're talking about with COVID, where we know exactly which subvariants are circulating predominantly in the U.S. and in Colorado right now.
Back to the mice study, youre asking about how effective these are going to be. Those mice studies suggest that these new vaccines will be about 20 times more protective against Omicron than the original vaccines that we've been having for more than two years now, and about 5 times more protective than the manufacturers first attempt at Omicron-specific bivalent vaccines with that BA.1 component.
I will add that human clinical trials are going on right now with the BA.4/BA.5 components and so we'll have more data in another month or two on that particular piece (of the puzzle).
3. When are the updated booster shots arriving to Colorado and when will I be able to get one?
So actually, the first shipment started arriving yesterday and we're going to have about 294,000 doses available on our first two waves of shipments. I think the majority of the doses will be arriving after Labor Day next week.
You'll be able to find a vaccine appointment at many of the same providers that have been offering COVID vaccines, again, for two years now so your retail pharmacies, your primary care providers, local public health agencies, and then our state-run clinics too so our mobile buses and our community vaccine sites that will be coming online very soon.
4. Is the state going to host a news conference when these boosters are available or is there going to be some sort of statewide communication via text telling Coloradans that these updated boosters are here and its time to go and get yours?
We haven't quite gotten to the point where we'll be doing direct outreach. I can see that happening after the first couple of weeks of rollout as that initial demand might decrease where we do some performed outreach to people to make sure they're aware of this change and this new vaccine.
5. The updated boosters are only available for people 12 and older (Pfizer) and 18 and older (Moderna). When will kids under the age of 12 be able to get these updated boosters?
I think that the manufacturers have said that it's going to be another month or two before they have the data that they would need to submit an application to the FDA for omicron-containing booster doses for kids under the age of 12.
6. Should parents wait until theyre approved, or should parents get their kids a booster from the original COVID-19 vaccine instead, even though the variant currently circulating in the state right now is omicron?
The guidance that has been in place for a long time hasn't changed. If you are due for a booster dose now, you should get it now. There is still some protection offered, particularly against severe disease and severe outcomes that come through the original vaccine for those younger age groups.
So if youre due I would get it now, knowing that something's coming along the way and in a month or two that you would be eligible for as well.
7. Where do we stand as far as children and their overall vaccination requirements.We saw the vaccination rates fall at the start of the pandemic for children.Has that percentage increased?If not, is the state looking at any programs to increase overall vaccination rates?
So you're right that COVID has disrupted just kind of our routine wellness child visits, our routine regular vaccine visits, and we've seen some increases over the last couple of years where we've kind of climbed out of that valley and out of that decrease.
But we are seeing continued, sustained decreases in other vaccines, in other age groups. One of the things the Colorado Department of Public Health and Environment has done recently is actually doing direct text and email outreach to families whose children are overdue for you know, required school vaccines for example, making sure that they're aware that their kids are missing one or more vaccines, and then linking them up with resources to get them back on track.
8. Should there be any hesitation about combining shots (i.e.: COVID and flu shots or COVID and monkeypox)?
I would say overall, no. If we're talking about flu and a new omicron dose, now is a perfect time to actually roll up both sleeves and get the flu in one arm, your omicron dose in the other, and that really has to do with timing: September and October are the best months to get your seasonal flu vaccine, it gives your body enough time to build protection before that flu virus is circulating widely and it's completely safe and effective to get multiple vaccines on the same day.
There are some special considerations for monkeypox. I don't have the data at hand, but I know it has to do with monkeypox and COVID mRNA vaccines and the theoretical risk of increased myocarditis or pericarditis if those are given on the same day.
(Editor's note: Myocarditis is an inflammation of the heart, whereas pericariditis is an inflammation of the pericardium - a two-layered, sac-like membrane that surrounds the heart.)
9. What about whooping cough (also known as pertussis). Theres reports that cases are on the rise in certain parts of the country. Are we seeing a rise? What is the real concern? Should people get vaccinated against whooping cough?
I don't know what our pertussis case rates look like right now. I'm unaware of any concerning equal increases, but I can say that based on data that we collected from schools and childcare centers for last school year, that we have seen some decreases in vaccine uptake that prevent pertussis from spreading.
Pertussis is a really contagious communicable disease and we want to make sure that we keep our rates high, to keep that out of out of communities and out of schools.
Editors note: Pertussis is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis. The illness is known for uncontrollable, violent coughing which often makes it hard to breathe. A CDC fact sheet states pertussis can affect people of all ages, but can be very serious, even deadly, for babies less than a year old.
10. The BA.5 variant is the predominant in Colorado, but infections, hospitalizations and the states positivity rate are all trending downward. The COVID-19 modeling team even estimates immunity from infection and hospitalization has increased over the past two months: Colorado has upwards of 60-65% immunity against infection and around 85-90% immunity against severe disease. Is it worth getting the BA.4/5 booster at this point for the fall if immunity from the BA.5 variant is this high?
I think it's a personal decision that someone can make and have conversations with their healthcare provider, but as the virus has evolved, so has the vaccine.
This is really exciting that we have science kind of closer to where variants are, that we're not chasing variants quite as much as we have been over the last couple of years. It's the latest and greatest vaccine that's available and getting this updated vaccine is really the safest and easiest way to be protected at maximum levels through the fall and winter.
Those wanting to get the bivalent omicron COVID-19 boosters should get them at least two months after their most recent dose of the COVID-19 vaccine. If you were recently infected, the CDPHE says you should wait at least three months after your SARS-CoV-2 infection before getting a BA.4/5 booster.
Seventy-two people in Maharashtra have died from swine flu in the past three months. The viral infection, which is caused by the H1N1 virus, is seeing a resurgence in western India this year, with Maharashtra alone recording 1,870 cases till August 23.
The caseload across India is likely to have crossed at least 2,800 so far this year, a threefold jump from the previous year. In contrast, H1N1 deaths for the entire country in 2021 stood at 12.
Does the resurgence of the H1N1 virus have anything to do with Covid-19 on the verge of turning endemic or is the virus following a cyclic pattern? Scroll.in spoke to doctors and scientists to understand why H1N1 cases plunged during the past two years only to bounce back this year.
H1N1 is a viral infection with symptoms involving cold, fever, sore throat, body ache and headache. In severe cases, it leads to pneumonia and acute respiratory distress syndrome.
The H1N1 pandemic first broke out in April 2009 and, unlike Covid-19, subsided quickly by 2010. The World Health Organization had declared the end of the H1N1 influenza pandemic by August 2010.
Since then it has been endemic, occurring in the form of a seasonal flu. Epidemiologist Dr Jayaprakash Muliyil, chairperson of the Scientific Advisory Committee at the National Institute of Epidemiology, said that once 40% of the population had attained herd immunity in the 2009-10 outbreak, the virus transmission slowed down.
Note that H1N1 is not as transmissible as coronavirus, he said. Each virus has a different threshold. According to Muliyil, even though 60% of the population was unexposed, the number of H1N1 cases began rapidly declining.
Swine flu made a reappearance in 2012, with a high number of cases in Maharashtra, Karnataka, Kerala, Tamil Nadu, Andhra Pradesh and Rajasthan. Because the susceptibility to infection increased in the population over a period of time, he said.
Since then, H1N1 has maintained a cyclic pattern. Cases spike around monsoon and winter, with the monsoons recording a larger share of cases than winters in India. Its susceptibility builds up over a year or two and then cases rise in the following year, Muliyil said, explaining that herd immunity against the virus wanes.
Before vaccination was rolled out, the measles epidemic too occurred once in two to three years, and rubella once in six to seven years. While a vaccine against influenza to prevent H1N1 was introduced in late 2009, its uptake in India remains low.
In the last decade, H1N1 cases surged in 2015 then 2017 and then in 2019. Since the past two years, however, the number of H1N1 cases have been at an all-time low. Cases in India dropped from 28,798 in 2019 to 2,752 with 44 deaths in 2020. In 2021, there was a further decline to 778 cases and 12 deaths.
But this year, cases are rising again. Data provided by the National Centre for Disease Control for H1N1 till June 30 showed that India recorded 424 cases and 12 deaths in the first half of this year. By July-end, the figure rose to 1,455 cases. At least 17 deaths were recorded in July alone. Trends indicate these figures are expected to rise further in August.
Gujarat and Karnataka are also seeing a rising trend in cases. In 2021, Karnataka had recorded 13 cases but as of July-end, it had 283 cases of H1N1. Gujarat had recorded 33 cases in 2021 and by July-end this year it had 205 cases.
Some medical experts say the lull in H1N1 over the past two years may have been related to the outbreak of the Covid-19 pandemic in early 2020. For one, Covid-19 appears to have diverted testing resources, which may have led to an underdetection of swine flu cases.
But some medical experts believe Covid-19 may have contributed to low H1N1 circulation as well. Dr Rajesh Karyakarte, Professor and Head of Microbiology Department at BJ Government Medical College, said whenever Covid-19 waves rose, other viruses sort of disappeared.
We saw this with all the three waves, he said. Now that Covid-19 is ebbing, H1N1 rise is not surprising. According to Karyakarte, when a virus infects a person, the body releases interferons. These are signalling proteins released by the bodys immune system to fight infection and other diseases.
Karyakarte noted that Covid-19, due to its high transmissibility, infected almost the entire population. When an H1N1 virus tried to infect the same person, the interferons would respond making it difficult for H1N1 to cause infection, he said.
Dr Pradeep Awate, Maharashtra state epidemiologist, also said that coronavirus managed to wipe out other viruses during the peak of the pandemic.
But Muliyil and Dr Gagandeep Kang, professor at the Christian Medical College, Vellore, said there is no scientific evidence to suggest that a dominant virus drives away other viruses.
According to Muliyil, what may have happened is that when two viral infections occur simultaneously in a body, one virus may modify the clinical outcome, duration of infection and severity caused by the other virus. That may have been the fate of H1N1 infection these past two years, he said.
Kang said that in the same family of a virus, a dominant variant may replace a weaker one, as seen with the Omicron variant of Covid-19. But there is no evidence to suggest that the coronavirus replaced H1N1 in 2020 and 2021. Influenza is not as transmissible as Covid-19. Mask adherence may have deterred its transmission further, she said.
An analysis of the 72 deaths in Maharashtra showed that 85% of the deceased were 40 years of age or older while 65% had another illness or suffered from a comorbidity.
In 30 to 35% deaths, oseltamivir medicine was started for the patient within two days of symptoms, Awate said. Oseltamivir is an antiviral used to treat H1N1. Awate added that the high fatality cannot be attributed to only the delay in treatment.
In Maharashtra, the current case fatality rate, or number of people dying out of those diagnosed, stands at 3.8%. Awate said that not all symptomatic cases are being tested, hence the base pool to calculate fatality rate is small.
There are four categories of patients those under A and B have mild symptoms such as a cold and low-grade fever that can be managed at home. Doctors and hospitals may or may not recommend a test for them.
In category C, patients develop pneumonia or have lung involvement leading to breathlessness while in category D, the symptoms are severe. Category C and D require hospitalisation and they are being actively tested, Awate said.
There are also few government laboratories in India that are testing H1N1 as of now. Some laboratories have raised concerns about the lack of sufficient testing kits. At private facilities, the cost per test is between Rs 4,000-Rs 5,000. In Maharashtra, senior health officials have urged the state government to cap the rates of H1N1 testing. The state government is yet to announce a price cap.
Kang, from the Christian Medical College, said 72 deaths in just three months in one state is a high figure. This is just the apex of the pyramid, she said. Essentially, it is telling you there is a lot of virus circulating.
Globally, the death rate of H1N1 is less than 1%. A higher fatality rate in India indicates a lack of adequate diagnosis. Kang said that compared to the issue of not diagnosing all H1N1 cases, a bigger concern is the complete lack of diagnosis of other influenza-like illnesses. It is like looking under a lamppost where there is light, said Kang. There are other influenza [viruses] which are in the dark and not even getting detected.
This reporting was supported by a grant from the Thakur Family Foundation. Thakur Family Foundation has not exercised any editorial control over the contents of this article.
National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci attends the daily coronavirus task force briefing at the White House in Washington, on April 13, 2020. File Photo / Reuters
Washington: President Joe Bidens medical adviser Anthony Fauci warned that the US should be prepared for "pretty bad flu season coupled with continued Covid-19 cases this winter when hell be stepping down from his post as the nations top infectious disease official.
The Southern Hemisphere, which annually sees new strains of flu appear before the North, has already experienced a more severe season than usual, Fauci said on Wednesday in an interview, and Americans should get flu shots when they become available.
An early uptick in influenza cases has alarmed Australian public health officials, where the flu season runs from April to September. They expect the season could be similar that of 2019, which saw record-setting levels of infections. That set off warning signals for the US about a potentially severe seasonal influenza this fall and winter, Fauci said.
"We should be prepared for that superimposed upon what I hope is the residual and not another spike of Covid, said Fauci, whos also director of the National Institute of Allergy and Infectious Diseases. "We better pay attention.
Fauci spoke with Bloomberg about his expectations for the nations continued fight against Covid, flu and other threats with pandemic potential just over a week after he announced plans to step down in December. His departure will end a historic career in which he advised seven presidents over nearly four decades on outbreaks ranging from HIV to Ebola and now monkeypox.
Earlier on Wednesday, the US Food and Drug Administration cleared new Covid-19 boosters from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE that are tailored to the latest omicron variants, a move toward additional protection as concern grows about potential new waves in the fall and winter. The clearance, which was based on animal data rather than human studies, is similar to the process in which flu shots are approved, Fauci said.
"Im comfortable with that decision, he said.
He added that the new boosters could help stymie a double-whammy of Covid and flu this winter, while acknowledging concern about low vaccination rates in the US. Looking ahead, Fauci hopes that the US continues to innovate and improve existing vaccines and therapeutics as the virus evolves.
"One of the mistakes weve made is that we concentrate on the problem thats right in front of you, and put of focusing on what might be a problem in the future, he said.
Fauci helped launch the Antiviral Program for Pandemics last year with the aim of developing and discovering next-generation treatments for Covid and other infectious diseases. He said he sees promise in a Covid therapeutic candidate from Japanese drugmaker Shionogi & Co. and believes that combination therapies will soon be necessary to counter resistance that can occur as the virus learns to evade more drugs.
Fauci said hes been in touch with drugmaker Pfizer Inc. and its Chief Executive Officer Albert Bourla about the need to test combinations of drugs including Paxlovid, the companys Covid antiviral. These studies could include collaborations with the National Institutes of Health, he said.
"Sooner or later, youre going to get resistance to Paxlovid, he said.
Faucis upcoming exit will cover all his government posts, wrapping up an NIH career spanning more than a half century, including 38 years leading NIAID. As infectious diseases chief, he leads the second-largest of the NIHs 27 institutes and centers, with a $6.3 billion budget.
Even if the pandemic takes a turn for the worse, hell go ahead with his plans to step down, he said. Biden has been "extraordinarily supportive of his decision, Fauci said.
While long one of the most visible US scientists, Covid-19 propelled him into the spotlight, where he became a household name. Hes been both lionized and vilified amid increasingly political divisions over public health measures such as masking.
Despite the divisions and vitriol, "I believe his enduring legacy as a physician-scientist and humanitarian is assured, Francis Collins, the former longtime NIH director and acting White House science adviser, said in an email. He called Fauci "the most dedicated public servant I have ever known.
Fauci said hell continue his work advancing public health and science outside of the government while mentoring the next generation of scientists, particularly those focused on HIV.
"Im not going to re-establish my laboratory, but I will be advising from a scientific standpoint because I do have a lot of experience in vaccinology and in HIV, he said. "I will be making input probably in advisory panels and on boards of scientific councils and things like that to go for a vaccine.
For Immediate Release: August 09, 2022
Espaol
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection. This will increase the total number of doses available for use by up to five-fold. The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection; in these individuals JYNNEOS is administered by subcutaneous injection.
In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand, said FDA Commissioner Robert M. Califf, M.D. The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.
JYNNEOS, the Modified Vaccinia Ankara (MVA) vaccine, was approved in 2019 for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. JYNNEOS is administered beneath the skin (subcutaneously) as two doses, four weeks (28 days) apart. For individuals 18 years of age and older determined to be at high risk of monkeypox infection, the EUA now allows for a fraction of the JYNNEOS dose to be administered between the layers of the skin (intradermally). Two doses of the vaccine given four weeks (28 days) apart will still be needed. There are no data available to indicate that one dose of JYNNEOS will provide long-lasting protection, which will be needed to control the current monkeypox outbreak.
Data from a 2015 clinical study of the MVA vaccine evaluated a two-dose series given intradermally compared to subcutaneously. Individuals who received the vaccine intradermally received a lower volume (one fifth) than individuals who received the vaccine subcutaneously. The results of this study demonstrated that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way. Administration by the intradermal route resulted in more redness, firmness, itchiness and swelling at the injection site, but less pain, and these side effects were manageable. The FDA has determined that the known and potential benefits of JYNNEOS outweigh the known and potential risks for the authorized uses.
To support the FDAs authorization of two doses of JYNNEOS administered by the subcutaneous route of administration in individuals younger than 18 years of age, the FDA considered the available JYNNEOS safety and immune response data in adults as well as the historical data with use of live vaccinia virus smallpox vaccine in pediatric populations.
JYNNEOS has been tested in individuals with immunocompromising conditions and has been found to be safe and effective in the trials that were performed to support approval. It was initially developed specifically as an alternative for use in immunocompromised individuals in the event of a smallpox outbreak.
On the basis of the determination by the Secretary of the Department of Health and Human Services on Aug. 9, 2022, that there is a public health emergency, or the significant potential for a public health emergency, that has a significant potential to affect national security or the health and security of United States citizens living abroad, and the declaration on Aug. 9, 2022, that circumstances exist justifying the emergency use of vaccines, the FDA may issue an EUA to allow emergency use of unapproved vaccines or unapproved uses of approved vaccines.
The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures. More information can be found on the agencys monkeypox webpage.
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Boilerplate
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
08/09/2022
As of Aug. 1, the CDC has confirmed 5,811 cases of monkeypox in the US. Several states have now declared the spread a public health emergency, including California, New York, and Illinois, which have 827, 1390, and 520 cases, respectively.
Many people are left wondering how to protect themselves from monkeypox and if another vaccine is in order. The good news is, unlike with COVID-19, a vaccine for monkeypox already existed prior to the global outbreak. Additionally, because scientists and health officials have known about monkeypox in humans since the first case in 1970, doctors have a better handle on how it spreads and how to prevent contracting it.
While the monkeypox vaccine supply is limited, an additional 786,000 were recently made available for use in the US with more supply expected in the coming weeks and months. Today, President Biden named FEMA's Robert Fenton as the White House National Monkeypox Response Coordinator and Demetre Daskalakis, MD, MPH, (a leading CDC official in HIV Prevention) as the White House National Monkeypox Response Deputy Coordinator. The new appointments will lead the Administrations's monkeypox strategy and, according to the announcement from the Biden Administration, "equitably [increase] the availability of tests, vaccinations and treatments."
If you're hoping to get a monkeypox vaccine or simply what to know what your options are, the following info will help you understand everything you need to know about getting vaccinated against monkeypox.
There are two FDA-approved vaccines currently available for monkeypox: JYNNEOS (also known as Imvamune or Imvanex) and ACAM2000. Both vaccines were recommended for use in the US prior to the monkeypox outbreak: JYNNEOS was licensed in the US in 2019 and ACAM2000 was recommended for use by the Advisory Committee on Immunization Practices in 2015.
JYNNEOS is manufactured specifically for monkeypox, while ACAM2000 is for use against smallpox and was made available for monkeypox under the Expanded Access Investigational New Drug application, as the monkeypox virus is closely related to smallpox. Even though it's not the exact same virus, the smallpox vaccine can indeed protect people from getting monkeypox; past data suggests that the smallpox vaccine is at least 85 percent effective in preventing monkeypox, according to the CDC. (Note: If you've been previously vaccinated for smallpox, it does provide some protection, but it may not necessarily be lifelong, according to the CDC.)
There's a larger supply of ACAM2000 available in the US compared to JYNNEOS, but the CDC does not recommend the ACAM2000 vaccine for those who have a weakened immune system, eczema or other exfoliative skin conditions, heart disease, or those who are pregnant or breastfeeding. Additionally, if you're living with anyone who falls under those categories (and cannot isolate from them), the CDC notes that you should not receive the ACAM2000 vaccine. That's because the vaccine contains a live virus called vaccinia, which can spread to other people from the vaccine site, according to the New York State Department of Health.
For JYNNEOS, two shots are necessary and the FDA recommends a 28-day wait period between doses. After the second shot, you'll reach maximum immunity at 14 days. For ACAM2000, there is only a single shot and maximum immunity is reached after 4 weeks.
At this time, the World Health Organization is not recommending vaccination for the general population. The CDC only recommends getting vaxxed if you've had a known exposure to monkeypox or if you're more likely to get monkeypox due to certain risk factors.
The at-risk group includes some healthcare or laboratory workers whose job may expose them to orthopoxviruses (the set of viruses that include smallpox, monkeypox, and cowpox); people identified by public health officials as having been in contact with monkeypox; people who've had a sexual partner diagnosed with monkeypox in the last two weeks; and people who've had multiple sexual partners in the last two weeks in an area with known monkeypox outbreak.
Exact eligibility also depends on where you live and your state's policies on vaccination access. For example, in San Francisco, men and trans people who have sex with men and had more than one sexual partner in the last two weeks, sex workers of any sexual orientation or gender, and people who were at a social event within the past two weeks where monkeypox was suspected or confirmed are all eligible for vaccination. In New York, you're eligible for the vaccine if you meet all of the following criteria: if you are a man or trans person who has sex with men, are age 18 or older, and have had multiple sex partners in the last two weeks. The best way to know if you're eligible for a monkeypox vaccine is to look at the specific requirements listed on your state's official website.
Wondering what your sex life has to do with your risk of monkeypox? While monkeypox is not an STI and anyone not just LGBTQ people can get monkeypox, the majority of cases so far have been amongst men who sleep with men. Monkeypox is spread through skin-to-skin contact, exposure to clothing, towels, and bedding infected with the virus, and through respiratory droplets or oral fluids (i.e. sneezing, coughing, or kissing). So while physical intimacy (read: skin-to-skin contact) is a definite way to spread the virus, it's not the only way.
If you fall into one of the above categories or meet the criteria necessary for vaccination in your city or state, your best bet for finding a monkeypox vaccine is to talk to your doctor, visit a clinic, or search for monkeypox vaccine providers in your area.
Two weeks ago, I received one of the Districts more than 20,000 doses of Jyennos monkeypox vaccine.D.C. has received the ninth highest number of vaccines in the United States with 24,175 doses shipped to the city as of Aug. 29. Because I am not a man who has sex with other men, I did not think that I would qualify for the vaccine. But after further research, I found out that those who qualify for the monkeypox vaccine in D.C. include people of any gender and sexual orientation who have had more than one sexual partner in the past two weeks, sex workers or staff members at establishments where sexual activity occurs. I was excited to play my part in preventing the monkeypox disease, but getting my first dose of the vaccine was an uncomfortable experience, both emotionally and physically.
Before my appointment, I assumed only gay men had access to the vaccine because of homophobic language surrounding the spread of monkeypox.To prevent other people from believing in the same misinformation, it is vital to avoid stigmas and stereotypes that fuel lies instead of slowing the disease, like blaming monkeypox on gay men. Other people like myself may qualify for the monkeypox vaccine but do not know it. While I am very thankful to qualify and receive the vaccine, I was misgendered several times at the appointment and continue to wait outlonger-than-expected sideeffects, which made my whole experience unenjoyable altogether.
The firstdisappointmentcame whenI got immediately misgendered while walking into the monkeypox vaccination site. My heart dropped into my stomach. Can we see verification of your appointment ladies, the police officer said in front of the D.C. Department of Health building. After showing them my QR code, the officer showed me to a waiting room full of chairs where the volunteers and doctors began to add maam to every phrase directed at me. Because monkeypox is mostly reported among men who have sex with other men in the United States, I thought I would be surrounded by a queer community that understood my non-binary identity. Healthcare establishments are typically stressful to me because of the heteronormativity that seeps through them. It is impossible to go to the doctor without discussing my queer identity because of questions about sexual activity and discussions about my body. I found myself in a similar situation at themonkeypox vaccination site, which felt unsafe, unwelcome and overwhelming.
Even after disclosing my gender identity and use of gender-neutral pronounson the forms that all patients fill out, the staff working at the vaccination site continued to misgender me. Being misgendered is exhausting because it is a constant self reminder that society categorizes me as a woman before anything else. Even when filling out the forms, I had to specify which gender I was assigned at birth, and while that information is necessary, it still stings to repeatedly be considered female. Getting my monkeypox vaccine showed me how even in predominantly queer spaces, LGBTQ+ people are still misunderstood and discriminated against. But nothing will change the fact that I got misgendered. Instead, my desire to practice safe sex and protect others from the spread of monkeypox outweighed the discomfort.
When the time came to receive the dose,confusion and panic set in the injection wasthe mostpainful vaccine that I have ever received. The Jynneos vaccine was injected through intradermal administration, a superficialinjection that doesnt reach the fat of the forearm as most vaccines do, creating a red, irritable lump right under the surface of the skin. The insertion itself was more painful than I anticipated.I was not prepared for the sheer discomfort that would come with the shot, making the physical side effects extra stressful.
Now two weeks out from vaccination, irritation from the shot has lingered. My forearm is still itchy, and the punctured patch of skin still hurts when touched symptoms known to last up to a month. Other side effects include headaches, muscle pain, fatigue and nausea, which are all common with other vaccines as well, but the extended periodof discomfort tied to the vaccine has been a first for me.
The initial and enduring pain and itching has definitely been manageable but also unexpected uncertainty that has generated unnecessary panic that I was not prepared to handle. All people planning to receive the vaccine should know what to expect about the shot and its side effects well before getting it not right before the needle enters their forearm.
Ultimately, getting the vaccine and avoiding monkeypox was worth the experience, but I wish D.C. Health informed me better ahead of time.The department could have included videos or pictures to explain the vaccination process in emails they sent about my appointment. Health care professionals at the site should also communicate better about the experience and what it entails. I left the vaccination sight jarred in both an emotional and physical sense, not looking forward to returning in a month for my second shot. Since no one told me, Ill tell you be aware of misgendering and lack of queer knowledge at D.C. Health. The injection might also hurt, and side effects can last up to a month.
Heres to a second dose that goes better than the first.
Riley Goodfellow, a sophomore majoring in political science, is the contributing opinions editor.
This article appeared in the September 1, 2022 issue of the Hatchet.
If you haven't been able to get a monkeypox vaccine, they'll be offered to anyone who's at least 18 this weekend during the three-day event.
GALVESTON, Texas Free monkeypoxvaccines are being offered to anyone 18 and over this weekend at Pride Galveston, according to the Galveston County Health Department.
You don't need an appointment and you don't have to be a resident of Galveston County. You can fill out a registration and screening formonline in advance.
Free monkeypox vaccines schedule
The vaccines will be available each day during the three-day event.
Galveston County Health Authority Dr. Philip Keiser said they only have five monkeypox cases there, but they want to keep those numbers low by vaccinating as many people as possible.
He said the Biden administration recently asked health departments to do outreach events like this one to help control the spread.
Now we wanted to do it, but we didnt have enough vaccine to really do it. So, we called up our colleagues at the state department of health services and ended up working with Fort Bend County, Harris County, City of Houston. And theyve all donated vaccines for this effort," Kaiser said.
He said they have enough doses for about 2,000 people.
They're also offering free HIV and syphilis testing and free condoms at Pride Galveston, which takes place Friday through Sunday.
Harris County Public Health is urging those eligible to receive the monkeypox vaccine to make an appointment as soon as possible.
This comes after the health department confirmed a patient who was presumptive positive for monkeypox, and also had other severe illnesses, died Sunday.
The Centers for Disease Control and Prevention is working to confirm the positive status of the test sample. The cause of death of the patient is unknown.
During a press conference Tuesday, Dr. Ericka Brown said those who are severely immunocompromised should get the vaccine.
Those wanting a vaccination can call the Harris County Public Health hotline at 832-927-0707 to make an appointment.
As of Tuesday, the health department reported a total of 563 monkeypox cases with 455 of those cases in Houston.
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.
