- Higher buprenorphine doses associated with improved retention in treatment for opioid use disorder | National Institute on Drug Abuse National Institute on Drug Abuse
- Larger dose of existing medication eyed as response to fentanyl Washington Examiner
- What you need to know about a new type of synthetic opioids The Morning Call
- New study suggests higher buprenorphine doses could help save lives News-Medical.Net
- Higher buprenorphine doses associated with improved retention in treatment for opioid use disorder National Institutes of Health (.gov)
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Tag Archives: doses
World’s first malaria vaccine: GAVI to launch 18 million doses in 12 countries, know how India’s Bharat Biotech and Serum Institute are going to play a crucial role – OpIndia
- World’s first malaria vaccine: GAVI to launch 18 million doses in 12 countries, know how India’s Bharat Biotech and Serum Institute are going to play a crucial role OpIndia
- 9 African Countries To Receive Millions Of Malaria Fever Vaccines + More | Network Africa Channels Television
- Nine new African countries to be given malaria vaccines The Irish Times
- African Countries to Get 18 Million Doses of First-Ever Malaria Vaccine AllAfrica – Top Africa News
- Africa to receive 18 million doses of malaria vaccine Reuters
- View Full Coverage on Google News
Comparative effectiveness of third doses of mRNA-based COVID-19 vaccines in US veterans
Specification of the target trials
We designed an observational analysis to emulate a hypothetical pragmatic trial of a third dose of BNT162b2 compared with mRNA-1273 and risks of COVID-19 outcomes in the VA healthcare system. Supplementary Table 3 summarizes the key protocol components.
Eligibility criteria included veteran status; age ≥65 yr or 18–64 yr with high risk of severe COVID-19 between 20 October and 18 November 2021 (based on the presence of at least one coexisting condition listed in Table 1)8 or ≥18 yr between 19 November 2021 and 8 February 2022 (based on national guidelines for third dose deployment)9,10; receipt of the second dose of an mRNA vaccine primary series at least 6 months earlier (based on the same guidelines); known residential address outside of a long-term care facility; and known smoking status and known body-mass index within the previous year. Individuals had to have used the VA healthcare system during the previous year (defined as receiving care at a station eligible to administer the vaccines under study and having at least one primary care visit) but not within the previous 3 d (which may indicate the start of symptomatic disease).
The interventions of interest were a third dose of either the BNT162b2 or the mRNA-1273 vaccine. To ensure balance of important characteristics across groups, eligible veterans in the target trial would be randomly assigned to one of these two vaccines within strata defined by calendar date of the third dose (5 d bins), calendar month of the second mRNA vaccine dose, age (5 yr bins), sex (male, female), race (White, Black, other, unknown), urbanicity of residence (urban, not urban), geographic location (coded as 19 categories of Veterans Integrated Services Network) and number of SARS-CoV-2 tests performed in the past 12 months (0, 1, ≥2).
The five outcomes of interest were documented SARS-CoV-2 infection, documented symptomatic COVID-19 and COVID-19-related hospital admission, ICU admission and death. For each eligible individual, follow-up started on the day the third dose of vaccine was received (baseline) and ended on the day of the outcome of interest, death, 112 d (16 weeks) after baseline, or the end of the study period (15 February 2022), whichever happened first.
Our target trial evaluates comparative effectiveness of a third dose of the vaccines during a period spanning times when SARS-CoV-2 Delta- and Omicron-variants were circulating. The Delta variant had decreased to a share of 26% of circulating variants in the United States as of 25 December 2021, as it was rapidly displaced by the Omicron variant, which rose to a 100% share as of 12 February 202211. To evaluate the comparative effectiveness during a period of Omicron-variant predominance, we considered a second target trial that was identical to the first trial except that the recruitment period was 1 January to 1 March 2022, and the only outcome of interest was documented SARS-CoV-2 infection because the period was too short to accrue a sufficient number of rarer, more severe outcomes.
Emulation of the target trials
We emulated both target trials using the VA healthcare databases3. Vaccination was identified using records from the Corporate Data Warehouse and the VA COVID-19 Shared Data Resource. SARS-CoV-2 infections were identified using the VA COVID-19 National Surveillance Tool3,12, which integrates data on laboratory tests with natural language processing of clinical notes to capture diagnoses documented inside and outside the VA healthcare system. Symptomatic COVID-19 was defined as ≥1 of the following symptoms documented within 4 d of SARS-CoV-2 infection: fever, chills, cough, shortness of breath or difficulty breathing, sore throat, loss of taste or smell, headache, myalgia/muscle pain, diarrhoea and vomiting. COVID-19 hospitalization was defined as a hospitalization within 21 d after documented SARS-CoV-2 infection, COVID-19 ICU admission was defined as an ICU admission during a COVID-19 hospitalization, and COVID-19 death was defined as a death within 30 d after documented SARS-CoV-2 infection. Supplementary Table 4 provides detailed information on all study variables and their ascertainment.
We attempted to mimic the stratified randomization of the target trial by matching persons who received a third dose of BNT162b2 and of mRNA-1273 on the basis of the calendar date of the third dose, calendar month of the second dose, age, sex, race, urbanicity of residence, geographic location, and number of SARS-CoV-2 tests performed in the past 12 months, using the same matching algorithm described in our previous study3.
To explore the possibility of residual confounding (for example, by underlying health status or healthcare-seeking behaviour), we incorporated two negative outcome controls7. First, we evaluated the risk of symptomatic COVID-19 in the first 7 d after the third vaccine dose. Second, we evaluated the risk of death from causes other than COVID-19 during the follow-up period.
Statistical analyses
Covariate balance after matching was evaluated by plotting the mean differences between variable values (standardized for continuous variables) for the vaccination groups, with a difference of 0.1 or less considered to be acceptable13.
Cumulative incidence (risk) curves for the vaccine groups were estimated using the Kaplan-Meier estimator14. We then calculated 16-week risks of each outcome and compared them between the vaccine groups via differences and ratios. We conducted subgroup analyses by age (<70 or ≥70 yr), race (Black or White), time since completion of the COVID-19 vaccine primary series (6–7, 8, or ≥9 months) and vaccine type of the primary series (BNT162b2 or mRNA-1273). We conducted sensitivity analyses that excluded eligible individuals who (1) had previously documented SARS-CoV-2 infection, (2) did not receive a homologous third dose compared with the COVID-19 vaccine primary series and (3) had a third dose that could not be identified as a booster dose on the basis of procedural codes available in the ‘Inpatient’ and ‘Outpatient’ domains, to compare recipients of vaccines at known doses, as the dose of mRNA-1273 differs for booster doses (50 μg) vs third primary doses (100 μg).
We used a nonparametric bootstrapping procedure (including both matching and subsequent analyses) with 500 iterations to calculate percentile-based 95% confidence intervals for all estimates.
Analyses were performed using R software version 3.6.0 (R Foundation for Statistical Computing) and SAS Enterprise Guide version 8.2 (SAS Institute).
Reporting summary
Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article.
Even Low Doses of Alcohol Cause Changes in Brain Circuitry
The study found that even low doses of alcohol prepared the brain for addiction.
How many drinks is too much?
According to a recent rodent study, even tiny amounts of alcohol may cause epigenomic and transcriptomic changes in brain circuitry in a region that is essential for the development of addiction.
The pathways that are involved in setting the brain up for addiction, according to researchers at the University of Illinois at Chicago, are also linked to the highs that come with drinking, such as euphoria and anxiolysis, a state of relaxed but awake sedation.
Subhash Pandey, director of the UIC Center for Research in Alcohol Epigenetics. Credit: Joshua Clark/University of Illinois Chicago
“This suggests that when the brain experiences the anti-anxiety effects of alcohol and the mood lift — the relaxation and the buzz — it is also being primed for alcohol use disorder,” said the study’s senior author Subhash Pandey, the Joseph A. Flaherty endowed professor of psychiatry and director of the Center for Alcohol Research in Epigenetics in the UIC College of Medicine.
Pandey states that while the research does not, for instance, imply that one drink results in addiction in individuals, it does provide some insights into why certain people are more susceptible to alcohol use disorder.
“We’re seeing that dependent behaviors may not always be from long-term, high-quantity habits but a result of rapid epigenetic changes in the brain, which we show in this study may start happening even at low doses,” said Pandey, who is also a senior research career scientist at the Jesse Brown Veterans Affairs Medical Center.
A paper published in the journal Molecular Psychiatry details Pandey’s experiments, which studied rats under control and alcohol exposure conditions.
In the experiments, rodents were exposed to low concentrations of alcohol, and researchers watched as they navigated a maze. After that, the researchers used
Read original article here
Only 3,500 doses of monkeypox vaccine made available to Ja – Tufton
With the monkeypox vaccine being in high demand and available doses being gobbled up by wealthy countries, Jamaica is set to receive just 3,500 doses by month-end.
Minister of Health and Wellness, Dr Christopher Tufton provided the update during Tuesday’s sitting of the House of Representatives. He said the acquisition is being facilitated through collaboration with the Pan American Health Organisation (PAHO) which announced this week that it has secured 100,000 doses from the Danish manufacturers.
“We are advised that the manufacturers of the smallpox vaccine that has been shown to be effective in protecting persons from moneypox has supplied limited amounts to the market and, as such, only approximately 3,500 doses of the vaccine have been promised to us. It is to be noted that we may not receive this amount, as the supply of the vaccine is in high demand with very limited supply,” Tufton said.
He said that in order to maximise the use of the vaccine and achieve the objectives of containment, Cabinet has given approval for administering the vaccine in this phase, as a post-exposure prophylaxis.
“The vaccine, once in country, will be administered only to persons who come into close contact with a diagnosed patient. These persons would include healthcare workers involved in direct care of monkeypox patients… and household contacts of confirmed cases, to include sexual partners,” Tufton explained
He added that once the country receives more doses of the vaccine, the prioritisation method will be refined, and the public will be advised.
“We have been advised by PAHO that it is not anticipated that additional doses will be made available to Jamaica before 2023,” the minister disclosed.
Meanwhile, PAHO Director, Dr Carissa Etienne, said the organisation is finalising arrangements for the acquisition of the 100,000 doses of the monkeypox vaccines from biotechnology firm Bavarian Nordic, for distribution to Latin American and Caribbean member countries.
Etienne said PAHO secured an agreement through its Revolving Fund facility, with Bavarian Nordic, which is headquartered in Hellerup, Denmark. She said this followed requests from member countries for support in accessing doses, which were made during a special session of the PAHO Directing Council in August, noting that 12 such were submitted.
“We are receiving the final logistical details, such as estimates for freight and insurance, and the deliveries will be prioritised based on the epidemiological situation in countries. So partial delivery to countries that requested will start, now, in September… making our region the first World Health Organisation (WHO) region to make monkeypox vaccines available to member states,” Etienne further informed.
“Our effort will permit countries in this region to access the vaccine, even in small quantities, which would not have been possible otherwise,” she added.
The director was speaking during PAHO’s digital media briefing on September 7 where she noted that the region of the Americas has the unenviable distinction of recording the highest number of confirmed monkeypox cases globally, since the WHO declared the disease a health emergency of international concern in July.
“As of September 6, over 30,000 monkeypox cases have been reported in the Americas, with most cases concentrated in the United States of America, Brazil, Peru and Canada. Thus far, most confirmed cases are among men… although at least 145 cases have been reported in women, and 54 cases among people under the age of 18,” she told journalists.
Additionally, the director said four monkeypox-related deaths have, so far, been reported in Brazil, Cuba and Ecuador.
Monkeypox is a rare disease resulting from infection by the monkeypox virus. The monkeypox virus is a zoonotic disease and is part of the family of viruses known as variola virus, which causes smallpox.
The symptoms are similar to those characteristic of smallpox, but milder; monkeypox is deemed rarely fatal.
The signs and symptoms associated with the disease include fever, chills, intense headache, extreme exhaustion, muscle and backaches, swollen lymph nodes and a rash that usually appears one to three days after the onset of the fever.
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City Offering Second Doses of Monkeypox Vaccine to New Yorkers and Begin Accepting Walk-In Appointments
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 city’s 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 we’ve gotten first doses to more than 70,000 New Yorkers, people can get their eagerly awaited second shots by appointment — and we’re 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:
- People who are 18 and older who have had multiple or anonymous sex partners in the last 14 days and identify as at least one of the following:
- A man (cisgender or transgender) who has sex with cis or transgender men or transgender women
- Transgender, gender non-conforming, or gender non-binary (regardless of the gender of your sex partners)
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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#046-22
MEDIA CONTACT: Patrick Gallahue/Victoria Merlino,
pressoffice@health.nyc.gov
Biden officials accelerating monkeypox vaccine effort with 1.8 million additional doses and other steps
That includes boosting supply with an additional 1.8 million doses of the Jynneos monkeypox vaccine, accelerating the US Department of Health and Human Services’ vaccine distribution timeline. HHS is also launching a new program aimed at making vaccines available and engaging with at-risk communities at large events attracting LGBTQ communities. And the administration is pre-positioning doses of an antiviral treatment for individuals who test positive.
The details, compiled in a White House fact sheet, were shared first with CNN.
The announcements come as the latest data from the US Centers for Disease Control and Prevention says that more than 13,500 monkeypox cases have been reported in the United States, with more than 39,000 cases reported worldwide as of Wednesday evening. There have been zero deaths in the US. Most monkeypox cases in the current outbreak have been linked to sexual activity. According to CDC guidance, “monkeypox can spread to anyone” through close contact, which is often skin-to-skin, as well as intimate contact that includes sex, hugging, massaging and kissing. Men who have sex with men are at high risk of contracting the virus.
In a briefing Thursday morning alongside HHS Secretary Xavier Becerra and CDC director Dr. Rochelle Walensky, White House monkeypox response coordinator Bob Fenton announced, “We have accelerated phase four of our national vaccine strategy. Starting Monday, an additional 1.8 million doses of vaccine will be available to jurisdictions for ordering.” That accelerated allocation phase will give states and jurisdictions more visibility into how much of the vaccine to expect as they make plans to distribute it.
The Biden administration is also providing more resources to local jurisdictions to help transition to the new type of injection to stretch out vaccine supply. The administration is encouraging states to provide the Jynneos vaccine intradermally — or between the layers of the skin — rather than subcutaneously, or under the skin, which would allow providers to stretch out the supply in one standard-dose vial. Los Angeles County in California and Fulton County in Georgia have both switched completely over to the intradermal vaccine, a White House official told CNN, as the administration is “providing technical assistance, support and resources to jurisdictions in the process of adopting and expanding intradermal administration.”
The officials also unveiled a new program aimed at reaching the populations at highest risk — gay and bisexual men — who have made up a majority of the confirmed cases so far.
“HHS is launching a pilot program that will provide up to 50,000 doses from the national stockpile to be made available for pride and other events that will have high attendance of gay and bisexual men,” Fenton said Thursday, calling it an “important” and “innovative” way to bolster local efforts to mitigate spread.
One of the upcoming events is the Charlotte Pride Festival and Parade this weekend in North Carolina. Officials acknowledge that this effort will not prevent spread around these events since the vaccine does not provide full immunity until two weeks after the second dose. But it is an effort to raise awareness and meet people where they are.
The CDC is also “offering assistance and support to jurisdictions to prepare for these large events, including helping develop vaccine and testing strategies to be stood up in and around these events, developing tools for information-gathering from event participants, and providing messaging and communications resources on vaccines, testing, and strategies to reduce one’s risk of contracting the virus,” the White House fact sheet said.
And officials outlined new efforts to make the treatment for monkeypox, Tpoxx, easier to access.
“Next week, HHS will be pre-positioning 50,000 courses of Tpoxx across the country. That’s nearly five times as many treatment courses than confirmed cases in the US. These courses will be made available to jurisdictions where the outbreak is most severe so that individuals can get treatment more quickly from their healthcare providers,” Fenton said.
Dawn O’Connell, HHS assistant secretary for preparedness and response, said the new effort reflects that “this is not a static response. We are continuing to assess where we are, evaluate what we need and make improvements in real time.” The Biden administration has faced criticism that it was slow to respond to the evolving outbreak.
The allocation will rely on a formula based 75% on the number of cases in a jurisdiction and 25% on the number of individuals at risk.
“It’s important that we all take monkeypox seriously, and it’s critical that we do all we can to keep this dangerous virus from spreading here,” Becerra told reporters Thursday, adding that there was “more work to do.”
US federal health officials also said the alternative method of administering smaller doses of the Jynneos monkeypox vaccine through intradermal injection would provide some protection as the nation continues to battle the virus.
Yet on the topic of exact efficacy numbers, Walensky said: “We don’t yet know how well this vaccine will work in this outbreak.”
CNN has reported that Jynneos has been approved for emergency purposes based on studies of immune responses, not clinical outcomes, because there haven’t been smallpox or monkeypox outbreaks large enough to test it.
The US Food and Drug Administration last week issued an emergency use authorization allowing the Jynneos monkeypox vaccine to be injected into the skin, a shift that can stretch the supply of vaccines as it would require a fifth of a dose used for a subcutaneous injection. The FDA said it based the authorization on a 2015 clinical study of intradermal injection compared with subcutaneous, finding that they produced similar results.
“So, when the strategy for intradermal dosing, which we anticipate will work just as well as subcutaneous dosing, we again met closely with health departments,” Walensky said. “This has been fluid, but we have been in close touch with our state and local health departments providing them all the data and all the information that we have when we have it.”
Dr. Peter Marks, the director of the FDA’s Center for Biologics and Evaluation Research, said the shift to intradermal injection was made “very carefully” and “with a lot of thought.”
“We are working very actively to make sure that the community has the information that we reviewed and can see the thought process that we use to come to the conclusion that giving this intradermally provided the same kind of protection as giving it by the subcutaneous route,” Marks said.
Dr. Demetre Daskalakis, the White House’s assistant monkeypox response coordinator, said, “It’s safe, it’s equally effective, and also allows us to expand extend vaccine so that we can maximize protection in the community. “
This story has been updated with additional reaction.
CNN’s Deidre McPhillips contributed to this report.
Biden officials accelerating monkeypox vaccine effort with 1.8 million additional doses and other steps
That includes boosting supply with an additional 1.8 million doses of the Jynneos monkeypox vaccine, accelerating the US Department of Health and Human Services’ vaccine distribution timeline. HHS is also launching a new program aimed at making vaccines available and engaging with at-risk communities at large events attracting LGBTQ communities. And the administration is pre-positioning doses of an antiviral treatment for individuals who test positive.
The details, compiled in a White House fact sheet, were shared first with CNN.
The announcements come as the latest data from the US Centers for Disease Control and Prevention says that more than 13,500 monkeypox cases have been reported in the United States, with more than 39,000 cases reported worldwide as of Wednesday evening. There have been zero deaths in the US. Most monkeypox cases in the current outbreak have been linked to sexual activity. According to CDC guidance, “monkeypox can spread to anyone” through close contact, which is often skin-to-skin, as well as intimate contact that includes sex, hugging, massaging and kissing. Men who have sex with men are at high risk of contracting the virus.
In a briefing Thursday morning alongside HHS Secretary Xavier Becerra and CDC director Dr. Rochelle Walensky, White House monkeypox response coordinator Bob Fenton announced, “We have accelerated phase four of our national vaccine strategy. Starting Monday, an additional 1.8 million doses of vaccine will be available to jurisdictions for ordering.” That accelerated allocation phase will give states and jurisdictions more visibility into how much of the vaccine to expect as they make plans to distribute it.
The Biden administration is also providing more resources to local jurisdictions to help transition to the new type of injection to stretch out vaccine supply. The administration is encouraging states to provide the Jynneos vaccine intradermally — or between the layers of the skin — rather than subcutaneously, or under the skin, which would allow providers to stretch out the supply in one standard-dose vial. Los Angeles County in California and Fulton County in Georgia have both switched completely over to the intradermal vaccine, a White House official told CNN, as the administration is “providing technical assistance, support and resources to jurisdictions in the process of adopting and expanding intradermal administration.”
The officials also unveiled a new program aimed at reaching the populations at highest risk — gay and bisexual men — who have made up a majority of the confirmed cases so far.
“HHS is launching a pilot program that will provide up to 50,000 doses from the national stockpile to be made available for pride and other events that will have high attendance of gay and bisexual men,” Fenton said Thursday, calling it an “important” and “innovative” way to bolster local efforts to mitigate spread.
One of the upcoming events is the Charlotte Pride Festival and Parade this weekend in North Carolina. Officials acknowledge that this effort will not prevent spread around these events since the vaccine does not provide full immunity until two weeks after the second dose. But it is an effort to raise awareness and meet people where they are.
The CDC is also “offering assistance and support to jurisdictions to prepare for these large events, including helping develop vaccine and testing strategies to be stood up in and around these events, developing tools for information-gathering from event participants, and providing messaging and communications resources on vaccines, testing, and strategies to reduce one’s risk of contracting the virus,” the White House fact sheet said.
And officials outlined new efforts to make the treatment for monkeypox, Tpoxx, easier to access.
“Next week, HHS will be pre-positioning 50,000 courses of Tpoxx across the country. That’s nearly five times as many treatment courses than confirmed cases in the US. These courses will be made available to jurisdictions where the outbreak is most severe so that individuals can get treatment more quickly from their healthcare providers,” Fenton said.
Dawn O’Connell, HHS assistant secretary for preparedness and response, said the new effort reflects that “this is not a static response. We are continuing to assess where we are, evaluate what we need and make improvements in real time.” The Biden administration has faced criticism that it was slow to respond to the evolving outbreak.
The allocation will rely on a formula based 75% on the number of cases in a jurisdiction and 25% on the number of individuals at risk.
“It’s important that we all take monkeypox seriously, and it’s critical that we do all we can to keep this dangerous virus from spreading here,” Becerra told reporters Thursday, adding that there was “more work to do.”
US federal health officials also said the alternative method of administering smaller doses of the Jynneos monkeypox vaccine through intradermal injection would provide some protection as the nation continues to battle the virus.
Yet on the topic of exact efficacy numbers, Walensky said: “We don’t yet know how well this vaccine will work in this outbreak.”
CNN has reported that Jynneos has been approved for emergency purposes based on studies of immune responses, not clinical outcomes, because there haven’t been smallpox or monkeypox outbreaks large enough to test it.
The US Food and Drug Administration last week issued an emergency use authorization allowing the Jynneos monkeypox vaccine to be injected into the skin, a shift that can stretch the supply of vaccines as it would require a fifth of a dose used for a subcutaneous injection. The FDA said it based the authorization on a 2015 clinical study of intradermal injection compared with subcutaneous, finding that they produced similar results.
“So, when the strategy for intradermal dosing, which we anticipate will work just as well as subcutaneous dosing, we again met closely with health departments,” Walensky said. “This has been fluid, but we have been in close touch with our state and local health departments providing them all the data and all the information that we have when we have it.”
Dr. Peter Marks, the director of the FDA’s Center for Biologics and Evaluation Research, said the shift to intradermal injection was made “very carefully” and “with a lot of thought.”
“We are working very actively to make sure that the community has the information that we reviewed and can see the thought process that we use to come to the conclusion that giving this intradermally provided the same kind of protection as giving it by the subcutaneous route,” Marks said.
Dr. Demetre Daskalakis, the White House’s assistant monkeypox response coordinator, said, “It’s safe, it’s equally effective, and also allows us to expand extend vaccine so that we can maximize protection in the community. “
This story has been updated with additional reaction.
CNN’s Deidre McPhillips contributed to this report.
New injection method approved to stretch doses
With sky-high demand for the nation’s limited supply of monkeypox vaccine, U.S. officials approved a new injection method to stretch out doses, but that does not mean the pressure for shots in places like San Francisco will ease right away.
Bay Area officials say they still need the federal government’s playbook on changing the way shots are given, with additional training needed for many vaccination staff.
The new method will use just a fifth of the previously administered dosage, but “you have to get it just right,” and that means ensuring health providers are trained in the precision nuances, said Peter Chin-Hong, an infectious disease expert with UCSF.
“There is no other choice,” he added. “Given the anemic trickling in of vaccine doses, there are not going to be enough for many, many months.”
California health department officials projected it will take considerable time to implement the new emergency-use authorization, granted on Tuesday by the Food and Drug Administration, to administer smaller doses of the Jynneos vaccine by using an injection between layers of skin rather than into deeper fat tissue.
Studies have shown this method can trigger a stronger immune response, but it is not commonly used in the U.S., necessitating clinician training before it becomes widely available.
“It would allow a smaller dose be given intradermally,” Dr. Erica Pan, the state epidemiologist told health care professionals during a Tuesday briefing. “We’ll have to work closely with all of you and health departments to implement this.”
That makes it difficult to know when enough providers will be trained up to realize a five-fold increase in the state’s monkeypox vaccine supply.
“I hope they can do it as soon as possible,” said Chin-Hong, noting the injection method has been extensively studied for polio and yellow fever. “We’re on the steep curve of people getting ill, infected and spreading it. On the hospital side where we see the most serious cases, the number of patients has doubled in the last week.”
California reported a cumulative 1,733 monkeypox cases as of Tuesday, with nearly a third of those concentrated in San Francisco and Alameda counties. Although anyone can get monkeypox, the outbreak is still largely contained within networks of men who have sex with men and is believed to be spreading primarily through prolonged skin-to-skin contact, including sexual activity.
The San Francisco Department of Public Health said it welcomes “every possible avenue that would allow us to get more people vaccinated against monkeypox as soon as possible.”
But as of Wednesday the department was awaiting federal and state guidance on the injection changeover, including instructions on dose extraction and administration, and stated, “SFDPH needs to understand adjustments that would need to be made to operations to ensure San Francisco’s vaccine providers continue to reach as many people who need the vaccine as quickly and equitably as possible. ”
It also anticipates instructions from state health officials on how to account for and register each dose when multiple doses are taken from single vials.
“We are also aware that the intradermal method of administering the vaccine, in which a dose is injected between layers of skin, will require updated protocols and additional training for many vaccinator staff and may be slower to administer,” the California Department of Public Health said in a statement to The Chronicle.
Across California, 98% of cases where there is available demographic data have been among men, and 96% are gay or bisexual, according to state data tallied in The Chronicle’s monkeypox tracker. Monkeypox, which can produce painful lesions, is not a sexually transmitted infection, but sustained contact through intimate encounters can result in transmission. Only 3% of those infected have required hospitalization.
Alameda County’s health department also said it is awaiting state and federal guidance before making any change in how it administers monkeypox vaccinations.
“Efforts to increase access to the monkeypox vaccine are appreciated and would be implemented, pending guidance, if it is determined to be in the best interest of Alameda County communities impacted by this epidemic,” Neetu Balram, the county’s public information manager, said.
White House officials said Tuesday that the new method is a “game changer” and would allow them to stretch the 400,000 available vials of the vaccine into about 2 million smaller doses.
“It’s safe, it’s effective, and it will significantly scale the volume of vaccine doses available for communities across the country,” Robert Fenton, the White House’s monkeypox response coordinator, told reporters.
While it would not completely alleviate the current demand, they said, it will at least help ease some of the strain.
About 1.6 million to 1.7 million Americans are considered by federal officials to be at the highest risk of the disease, primarily men with HIV or men who have a higher risk of contracting it. Vaccinating that group would require more than 3.2 million shots, with full vaccination consisting of two shots per person.
“Gay, bisexual and other men who have sex with men in recent history have demonstrated significant confidence in vaccines. … I imagine that we will likely still run out of vaccines before we run out of arms,” Dr. Demetre Daskalakis, the White House monkeypox response deputy coordinator, told reporters.
Scarcity of vaccine supply has made the rollout to the eligible population frustratingly slow for many. On Aug. 4, the Biden administration declared a national monkeypox health emergency. San Francisco and California issued similar proclamations days earlier.
California has only received 109,000 vaccine doses to date, Pan said, although the state expects another allocation next week. Jurisdictions can order additional vaccine supply starting on Aug. 15 or when they have used 90% of their current vaccine allotment, according to the White House.
“One worry I have with these delays is equity,” said Chin-Hong. “You have to be electronically savvy and able to take time off to line up for vaccines. That doesn’t work for gig workers or closeted with their sexuality. Even if they do with the five-to-one vaccine, there are going to be holes they have to figure out.”
Aidin Vaziri (he/him) is a San Francisco Chronicle staff writer. Email: avaziri@sfchronicle.com
U.S. declares monkeypox a public health emergency, expedites Jynneos doses
The health secretary is also considering a second declaration empowering federal officials to expedite medical countermeasures, such as potential treatments and vaccines, without going through full-fledged federal reviews. That would also allow for greater flexibility in how the current supply of vaccines is administered, Becerra said.
Federal officials Thursday afternoon said they were still finalizing the formal declaration of a public health emergency, which would be posted on an HHS webpage.
The administration’s announcement follows similar decisions by health officials in New York, California and Illinois and global health leaders. The World Health Organization on July 23 declared that monkeypox was a public health emergency of international concern, its highest-level warning, after confirmed outbreaks in about 70 countries where the virus has not historically spread.
Health officials Thursday also said they were taking steps to improve access to Jynneos, the only vaccine approved by the Food and Drug Administration to protect against the virus through a two-dose regimen. Federal officials have identified about 1.6 million people as highest risk for monkeypox, but the U.S. has only received enough Jynneos doses to fully cover about 550,000 people. Officials said that they had expedited an additional 150,000 doses of Jynneos to arrive in September, and FDA Commissioner Robert Califf told reporters that a “dose-sparing” plan was under serious consideration.
“We’re considering an approach … that would allow health care providers to use an existing one-dose vial of the vaccine to administer a total of up to five separate doses,” said Califf, adding that the plan was “looking good” and would be finalized in the coming days.
Federal leaders had spent weeks debating whether to declare monkeypox a public health emergency, and officials said that Thursday’s planned announcement is part of a broader push to contain the virus. The announcement follows the White House’s decision this week to name Robert J. Fenton Jr., a longtime official at the Federal Emergency Management Agency, as the coordinator of the national response to the virus.
“This public health emergency will allow us to explore additional strategies to get vaccines and treatments more quickly out in the affected communities. And it will allow us to get more data from jurisdictions so we can effectively track and attack this outbreak,” Fenton said Thursday.
Thursday’s announcements were cheered by President Biden’s allies on Capitol Hill, including House Oversight Chairwoman Carolyn B. Maloney (D-N.Y.), who had pressed the administration to declare an emergency.
“This critical step will allow the Biden administration to build on the progress it has already made to expand the availability of vaccines, testing, and treatment nationwide,” Maloney said in a statement.
But public health experts called Thursday’s announcement overdue, saying that the emergency declaration had been long-needed to fast-track more funding and flexibility.
“It’s about time,” David C. Harvey, executive director of the National Coalition of STD Directors, said in a statement. “With this declaration in place, the administration must act quickly to allocate funding to state and local health departments for … clinical services” to deal with monkeypox.
The top Republican on the Senate’s health committee said that the Biden administration had failed to move quickly to contain the virus.
“I have been baffled by the degree to which the administration seems to be disconnected from the realities on the ground for health care providers, public health personnel, and, most importantly, patients,” Sen. Richard Burr (R-N.C.) wrote in a letter to Becerra, calling the government’s response “a devastating public health failure.”
More than 6,600 cases of monkeypox have been confirmed in the United States since May 18 with the vast majority occurring among men who have sex with men — a total that has doubled about every 8 days, but which experts believe is a significant undercount. Officials have also reported at least five cases of monkeypox in children, who are believed to have gotten infected through household transmission.
WHO officials last week advised men who have sex with men to temporarily reduce their number of sexual partners in an attempt to reduce transmission.
While health officials have stressed that monkeypox poses far fewer risks than coronavirus — with just a handful of deaths globally and none to date in the United States — the virus can lead to fever, swollen lymph nodes, rash and often painful lesions that can last for weeks and result in scarring. The virus also is linked to more severe complications in children, pregnant women and people with immune conditions.
The infectious-disease, which comes from the same family of viruses as smallpox, spreads primarily through close contact, and experts say they believe skin-to-skin exposure during sexual activity is a major source of transmission in the current outbreak. But they caution that the virus spreads through other forms of touch and can circulate outside the gay community, noting a handful of cases in women and children.
Some Biden officials had previously argued that declaring an emergency for monkeypox would call attention to the growing outbreak and strengthen the nation’s overall response. For instance, the emergency declaration can be used to compel hospitals to report more data about their monkeypox patients, and enable the Food and Drug Administration to expedite medical countermeasures that might otherwise take months or years to undergo traditional regulatory reviews. Many public health experts had also affirmed the WHO’s decision to declare a public health emergency, saying that a coordinated global response is “essential” to beating back the growing outbreak.
Federal officials on Thursday also circulated an “options memo” for how a public health emergency would improve the nation’s monkeypox response, according to two officials who were not authorized to comment. POLITICO first reported the existence of the memo.
But Becerra’s decision to declare monkeypox an emergency could raise political complications for the White House, which has faced calls from advocates to declare gun violence a public health emergency and climate change a national emergency. Democrats like Sen. Elizabeth Warren (D-Mass.) and reproductive health rights groups have also lobbied the administration to declare access to abortion a public health emergency in the wake of the Supreme Court’s recent ruling that overturned Roe v. Wade and led to new abortion restrictions around the nation.
The Biden administration has also continued to renew public health emergency declarations, which expire every 90 days, for opioids and the coronavirus.