Category: Vaccine

New monkeypox vaccine plan may stretch nation's limited supply

The U.S. will use smaller doses of the monkeypox vaccine in order to stretch its supply.

Scott L. Hall, USA TODAY

About 600 doses of a monkeypox vaccine have been administered to Wisconsinites as of Tuesday, the state Department of Health Services said in a press conference Wednesday.

About 200 doses were given at the start of this week and another 300 over last week.

Health officials have confirmed 32 cases of monkeypox in the state as of Tuesday, according to DHS.

So far, the federal government has allocated 5,986 vaccine doses to Wisconsin and 3,286 have arrived in the state so far. The state health agencywill be able to order additional doses on Aug. 15.

Each vial of the vaccine can now be used to vaccinate up to five people from a single dose, following an announcement from the Food and Drug Administration on Tuesday.

The Jynneosmonkeypox vaccine is now available for adults as anintradermal injection, which penetrates only the top layerof skin. Previously, the vaccine was given only as a subcutaneous shot, which is a deeper shot that is delivered to the fat layer under the skin.

RELATED: Monkeypox has spread to Wisconsin. Here's what you need to know about the disease and how to avoid it.

RELATED: Demand for monkeypox vaccine outstrips limited supply of doses available in Wisconsin

Authorization of the alternate method of delivery of the shot stretchessupply of the vaccine fivefold because it uses less of the dose.

"Given the studies that we have, both vaccines the high-dose or low-dose seem to have the same beneficial effect on the immune system," said Dr. Ryan Westergaard, chief medical officer for the state Department of Health Services.

Following the FDA's authorization, DHS is working with vaccinators to provide them with the equipment and training to deliver the vaccines intradermally to extend the state's supply.

There are five monkeypox vaccine hubs forthe state: Medical College of Wisconsin, SSM Health, Mayo Clinic Health System in Eau Claire,the state agency's headquarters in Madison and Prevea Health.

As of this week, 40 clinical and public health siteshave placed orders for the monkeypox vaccine, Westergaard said, but the health departmenthopes to open more vaccination sites as the state gets more doses of the vaccine.

Monkeypoxspreads by closecontact with an infected person's fluids and lesions for a period of time, respiratory droplets from an infected personor by touching items contaminated with those fluids.

"Anyone with skin could be infected by this," Westergaard said.

Doses of theJynneos monkeypox vaccine are available in Wisconsin for prioritized groups:those who have had sexual relations in the last two weeks with someone diagnosed with monkeypox, people who have attended an event or venue with known monkeypox exposure and, notably, gay and bisexual men, trans men and women, gender nonconforming peopleand any man who has had sex with menin the last 14 days.

To reduce spread:

Contact Benita Mathew atbmathew@gannett.com. Follow her on Twitter at @benita_mathew.

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600 in Wisconsin receive monkeypox vaccination, says health department - Green Bay Press Gazette

Participants

This study enrolled adults aged18years living in Miyagi Prefecture who had a history of recent close (high-risk) contact with COVID-19 cases and had provided their nasopharyngeal swab specimens at a drive-through outpatient clinic for the testing of COVID-19 (Tohoku University Medical Office) at a location away from Tohoku University Hospital in Sendai City, Japan, managed by the local governments and Tohoku University, between January and May 2022. This period corresponded to the sixth nationwide wave of the COVID-19 outbreak, exclusively caused by the Omicron variant. During the study period, a sampling test of the viral genome revealed that more than 99% of the infections in the locality were caused by the Omicron variant. Because the main objective of this study was to evaluate vaccine effectiveness in those who had completed three vaccine doses (three-dose group) compared with those who were not vaccinated (no-vaccine group) or had completed two doses (two-dose group), those who had completed only the first vaccine dose (one-dose group) at the time of the nasopharyngeal swab test were excluded from subsequent analyses. This study was conducted before the fourth dose of COVID-19 mRNA vaccines became available in Japan. A flowchart of the study design is shown in Fig.1.

Flow diagram of the study design. Among the overall individuals tested by reverse transcription-polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples at a large screening test center in Japan between January and May 2022, (1) adults aged<18years, (2) those without a certain contact history, (3) those who had completed only one vaccine dose, and (4) those who were less than 7days after the last vaccination were excluded. Consequently, 767 adults were eligible for subsequent analyses.

From these tested individuals, information regarding the demographics (age and sex), detailed situation of the contact, vaccine completion status (number of completed vaccine doses and manufacturer of the vaccines), elapsed time from the last vaccination at the time of swab test, and results of nasopharyngeal swab reverse transcription-polymerase chain reaction (RT-PCR) test for SARS-CoV-2 were collected. The timing of nasopharyngeal swab sampling in most enrolled cases was scheduled 45days after contact with COVID-19 cases. Individuals who had already passed more than 14days from the last contact history were not tested at the testing center. To evaluate the effectiveness of the vaccine against COVID-19-associated symptoms 45days after the infection, the presence of symptoms including cough, dyspnea, fatigue and a body temperature37.5 was recorded at the time the PCR swab was taken.

To detect the virus in the sampled swab specimen, RT-PCR was performed to detect the viral nucleocapsid protein set no. 2 (N2) gene. A primer/probe set designed by the National Institute of Infectious Diseases in Japan (NIID_2019-nCoV_N_F2, R2, and P2) was used11. The details of the thermal cycling conditions have been previously reported12.

The closeness of contact with COVID-19 cases was judged using the criteria defined by the government. More specifically, fulfillment of all of the following four criteria was considered to be a close contact history: (1) contact with a patient with COVID-19 from 2 to 14days after the onset of symptoms or positive RT-PCR test results, (2) not wearing masks, (3) contact involving<1m distance, and (4)15min of contact. All other contact patterns with patients with COVID-19 were regarded as lower-risk contacts. The closeness of the contact in each of the tested individuals was assessed in advance before the RT-PCR test by the local government staff in public health centers.

The distributions of non-normally distributed variables were described as the median and interquartile range (IQR; 2575 percentiles). Comparisons of non-normally distributed variables between the two groups were performed using the MannWhitney U test, and those between the groups were performed using the KruskalWallis test, followed by the Scheff post-hoc test. The RT-PCR test positivity rate was used as the marker of the risk of infection in each subgroup, and the rates between those who were not vaccinated (zero-dose group), those who had completed only two doses (two-dose group), and those who had completed all third doses (three-dose group) were compared using the chi-square test. Risk ratios (RR) and 95% confidence intervals (CI) for RT-PCR test-positive participants between those with no vaccination and those who had completed the third booster vaccination were also evaluated. RR was calculated as the risk of infection in the three-dose group divided by the risk in the no-vaccine group. Vaccine effectiveness (%) and 95% CI were estimated as (left(1-RRright)times 100). Sample size calculation was performed before performing the chi-square test, which revealed a required sample size of n=32 in each group for a large effect size of =0.50, (alpha ) = 0.05, and power (i.e., (1-beta ))=0.80. Statistical significance was set at P<0.05. Adjustment for multiple testing was not performed because of the nature of the subgroup analyses in this study. To visually confirm the relationship between the elapsed time from the last vaccination and RT-PCR test-positivity rate in the two- and three-dose groups, the rolling average (5days) of the RT-PCR test positivity rate in these groups was depicted. Statistical comparisons and sample size calculations were performed using R Statistical Software (version 4.0.5; R Foundation, Vienna, Austria).

All methods were performed in accordance with relevant guidelines and regulations. All study protocols were approved by the institutional review board of the Tohoku University Graduate School of Medicine (approval number: 2020-1-535). Informed consent was obtained from all the participants.

Link:

Effectiveness of third vaccine dose for coronavirus disease 2019 during the Omicron variant pandemic: a prospective observational study in Japan |...

For the third summer in a row, school leaders are facing the question of what if anything theyre going to do to stop the spread of Covid-19 when students return to classrooms.

One thing is clear: Almost none of them will be requiring vaccines.

Just 31 percent of children between 5 and 11 in the US have been fully vaccinated, and 61 percent of 12- to 17-year-olds have been. (Only about 3 percent of children under 5 had received a first dose by July 20.)

Still, no state in the country is planning to require student vaccinations, a marked turnaround from where things seemed to be headed last winter, when multiple states and school districts suggested vaccine mandates were coming soon. Only Washington, DC, has announced a mandatory school vaccine policy this fall, for students 12 and older.

Other mitigation measures from masks to ventilation may also be on their way out. The Centers for Disease Control and Prevention will likely soon recommend easing school testing, quarantine, and social distancing requirements, CNN reported last week. (Many schools often disregarded CDC guidelines, but the update is a sign of how expectations have shifted.)

Burbio, a company that specializes in aggregating school calendars, reported that so far, the vast majority of school districts it tracks nationwide will not be requiring masks this fall. And a June CDC study found just under 40 percent of American public schools had replaced or upgraded their HVAC systems to provide improved ventilation.

For the last three years, school requirements closed or open? masks on or off? have been a battleground in the culture war over Covid-19. Fear of wading back into the polarized fights over vaccination is one reason school leaders have backed away from requiring the shots. So is the fact that vaccines for children under 12 are not yet fully approved by the FDA.

But an even bigger factor might be mass indifference: American adults are more hesitant to vaccinate their kids, especially younger kids, than they were to get shots themselves. And no influential health group or federal agency is pushing states to require them to do so.

In October 2021, Californias Democratic Gov. Gavin Newsom was the first in the nation to announce a planned Covid-19 vaccine mandate for K-12 students once the FDA had fully approved the shots. He said at the time that it could take effect as early as January.

Some school districts in the state tried to impose vaccine mandates that would take effect even earlier. Los Angeles Unified School District, the second largest in the nation, announced in September 2021 that students 12 and older must be fully vaccinated by December 19, or switch to online schooling. In Oakland, California, the school board passed a similar vaccine requirement in late September for eligible students, with a deadline of January 1. The Pfizer vaccine for 16- and 17-year-olds had been fully approved in August, while the shots for 12- to 15-year-olds were still under FDAs emergency use authorization.

By December 2021, facing both political and legal pressure, school leaders pushed back the vaccine mandates to the start of the 2022-23 school year. LAUSD board president Kelly Gonez has said their decision was not about conceding to a vocal minority of anti-vaxxers, although those who oppose mandatory Covid vaccines hailed the delay as a victory.

But as 2022 continued, pressure for youth Covid-19 vaccines declined. A state lawmaker in California who had introduced a bill to require Covid-19 vaccines for K-12 students withdrew it in April, saying that focus needed to be on ensuring access to the vaccine. The same week, the California Department of Public Health announced it would no longer add the Covid-19 vaccine to its list of mandated childhood vaccines for public schools because they had not all yet received full FDA approval. The earliest the requirement would take effect, they said, was July 2023. Individual school districts like Los Angeles followed suit.

A California health department spokesperson told Vox that the state was waiting to ensure sufficient time for successful implementation of new vaccine requirements. As of last month, the vaccines are now fully approved for ages 12 and up, but not yet for younger children. The California health agency also said even after all the shots receive full approval, officials would still take into consideration other health group recommendations before issuing a new mandate.

Louisiana, likewise, retreated on a student vaccine mandate Democratic Gov. John Bel Edwards announced last November. New Orleans Public Schools is the only district in the state to require students to be vaccinated against Covid-19, though policy enforcement has been mixed. New York City Mayor Eric Adams, who said in January he was considering a student vaccine mandate for the fall, quietly dropped the idea, scaling it back to a requirement for students participating in certain sports and other high-risk extracurriculars like choir.

The California situation illustrates the several factors at play in schools reluctance to require vaccines.

One issue is the lack of full FDA approval for vaccines for younger children. The US Supreme Court has endorsed states authority to require student vaccines, but many policymakers were wary of testing that legal authority for Covid-19 shots that had only received emergency use authorization. (The Justice Department issued a memo last summer saying schools could legally do this, but the threat of defending those decisions in court was both real and unappealing.)

As a result, even once youth vaccines became available, leaders hesitated to require them without full FDA approval. But now the FDA has fully approved vaccines for teens and adolescents, and that still hasnt led states or districts to require the shots for older kids.

Policymakers are also wrestling with the fact that the virus is much less deadly for children compared to adults. (Approximately 1,180 of the more than 1 million Americans who have died of the virus were 17 or younger, though health experts stress vaccination can still help protect against these rare outcomes.) Kids can also catch the virus in school and spread it back at home to their more vulnerable parents and grandparents, but that risk became easier to tolerate once adult vaccines were approved.

Most school districts were wary of igniting another public school culture war battle at a time when students were still struggling to regain academic and social skills lost during the pandemic. On the eve of the anniversary of the January 6 riot, former President Donald Trump blasted President Joe Biden for supposed talk that his administration might enforce a vaccine mandate for school children and urged MAGA nation to rise up against any such requirements. (The Biden administration has not publicly discussed any student vaccine mandate.)

Conservative law firms were also helping to mount legal challenges against proposed Covid-19 vaccine requirements, and groups fighting mask and vaccine mandates have insisted there is no reason to vaccinate kids to protect more vulnerable populations.

Polling also indicated that many parents were not eager to have their kids get the shots, and administrators felt hesitant to impose any rules that could keep vulnerable students particularly Black and Latino students out of in-person learning for even longer than they already endured.

The Covid-19 Vaccine Monitor, run by the Kaiser Family Foundation, reported recently that parents intentions to vaccinate their older children have remained relatively steady since the start of the year: About six in 10 parents of those aged 12-17 say their child has been vaccinated (57 percent); about 30 percent say they will definitely not get their teen vaccinated. Eight percent said they will only vaccinate their child if required.

Covid vaccination uptake is even lower among children ages 5-11, and nearly half of parents of that age group either say they will only get them vaccinated if required to do so (10 percent) or say they definitely wont (37 percent).

While all demographic groups in the KFF study expressed concerns about long-term effects and side effects, Black and Hispanic parents also voiced more concerns over the logistics of getting their kids vaccinated.

Jeremy Singer, an education policy researcher who has been studying Covid-19 school reopenings, said its notable that resistance to youth Covid-19 vaccine requirements is present in nearly all school districts. One reason why, he said, may be what school districts are hearing from parents and community members.

District leaders may still be feeling risk-averse, but at this point the riskier thing for them could be to impose an unpopular mandate, he said.

In January 2022, Singer and his colleagues surveyed Detroit parents on whether they supported or opposed various health measures. Parents expressed overwhelming support for almost every measure ... except vaccine mandates for staff and especially students, for which there was a lot more ambivalence, he said of their findings, which are not yet published.

Back in February, Education Secretary Miguel Cardona wrote in a letter to schools, The #1 tool we have available right now to make sure our schools remain safe and open for all students is vaccination, and encouraged schools to provide information and host clinics. But the department has stopped short of encouraging schools to require the shots. Elaine Quesinberry, a spokesperson for the Education Department, referred Voxs questions about student Covid-19 vaccines to the CDC, and the CDC did not return a request for comment.

The CDCs last updated schools guidance, posted in late May, does not recommend schools require the shot, though encourages schools doing targeted outreach to promote it. A White House spokesperson declined earlier this year to say if Biden would support schools requiring Covid-19 vaccines for students if the vaccines had received full FDA approval.

Susan Martin, a spokesperson for the American Academy of Pediatrics, referred Vox to their policy statement recommending Covid-19 vaccines for all eligible children, and their interim guidance on safe schools, which says Covid vaccination and boosters should be encouraged.

Even teacher unions which were influential in shaping school reopening decisions in the 2020-21 school year have not staked out youth vaccination as a dealbreaker for safe in-person learning. An NEA spokesperson said, Our position on vaccines have not been changed or updated at this point and referred Vox to a position statement published in December 2020, which said parents should follow vaccine guidelines from the CDC and the American Academy of Pediatrics.

Back in October 2021, the last time the American Federation of Teachers released a formal statement on youth vaccines, president Randi Weingarten said vaccine approval will be critical to keeping our kids safe and healthy, and making sure our schools stay open and remain safe and welcoming for all. In a statement to Vox, Weingarten said the group is awaiting full authorization by the FDA to inform requirements for kids but in the meantime we must ensure the other guardrails, including revamped ventilation, are in place.

The big exception is in the nations capital. In late December, Washington, DC, councilmembers voted overwhelmingly in favor of legislation requiring all eligible students to get vaccinated against Covid-19.

The bill set a vaccination deadline for March 1, 2022, though enforcement was delayed until the start of the 2022-23 school year, a concession to help keep students in school. At the time, just over 60 percent of DC young people ages 12-17 had received their two shots.

Last month the city announced it would move forward with its back-to-school vaccination policy, requiring Covid-19 vaccines for all students ages 12 and older within the first 20 school days. DC is also ramping up outreach and enforcement for its other required youth vaccinations like measles and mumps which the city didnt enforce strictly last year, and students fell behind on.

I think one thing that is important to know in terms of how DC is moving forward is were not just talking about the Covid vaccination, we are having a conversation about routine child immunization, and the Covid vaccine just happens to be a part of the series where kids need to get caught up, said Christina Henderson, a DC councilmember and the lead sponsor of the bill requiring Covid-19 vaccines for students.

Henderson said their effort this year involves more concerted help from pediatricians, school leaders, and public health officials, to stress the importance of vaccination and to relay the evidence that millions of young people by now have safely received the shots.

Henderson pointed to the recent case of an unvaccinated 20-year-old with polio, and stressed that this is not the time to waver on the importance of pediatric vaccination. We also know mandates work, she added, noting that while many teen athletes were initially ambivalent about getting vaccinated, following DC Mayor Muriel Bowsers vaccination requirement to participate in sports last September, even hesitant students got their shots.

The Washington Post reported in late July that about 85 percent of DC students ages 12-15 have been vaccinated against Covid-19, but just 60 percent of Black children in that age range have been.

If one school has a high unvaccinated rate of students, then we will bring a mobile vaccine clinic there, Henderson said. We are not going to assume that parents are purposely saying I dont want to get my child covered. It might just be they were away all summer and didnt know about it, or didnt have time.

Kathryn Lynch-Morin, a spokesperson for DCs Office of the State Superintendent of Education, told Vox that city agencies have been coordinating closely with schools to support them with technical assistance, guidance, and outreach to families.

Our children belong in school with their friends and teachers who care about them, she said. But, we know if an outbreak of one of these serious or deadly diseases were to occur, it could have a harmful impact on our children, families, and staff. We also know that vaccinations save lives.

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Vaccines for Covid-19 arent required in schools this fall - Vox.com

The global monkeypox outbreak is occurring in the gay, bisexual and other men who have sex with multiple male partners. Currently, the risk of contracting monkeypox for the public remains very low.

Vaccination is an important prevention strategy to contain the outbreak. Nonetheless, the supply of monkeypox vaccines continues to be low compared to demand nationwide. However, the region does continue to receive its allocation of monkeypox vaccine from the California Department of Public Health.

Currently, the Centers for Disease Control and Prevention primarily recommends the monkeypox vaccine for people exposed to someone who has been diagnosed with confirmed or probable monkeypox infection and persons with immunocompromising conditions who are at greater risk of developing severe disease or complications if they contract the virus.

The 1,550 vaccine doses distributed this week reflect the vaccines allocated, not what remains in stock. Vaccines can be found at the following healthcare systems, federally qualified health centers and clinics by appointment only:

County Public Health Centers and STD clinics also have about 300 doses of vaccine available by appointment only, as well.

Of the 1,550 doses being distributed this week, almost all are to the healthcare providers and clinics above, as well as a county reserve for close contacts of confirmed or probable cases.

Testing is widely available through healthcare providers and involves using a swab to sample suspect skin lesions. People with no healthcare provider, who need testing, can call 2-1-1 to be referred to a provider. 2-1-1 is not presently providing vaccination appointments.

The monkeypox vaccine is a two-dose series, administered 28 days apart. Following guidance from the California Department of Public Health, given the low supply of vaccine, the County is presently recommending that first doses be administered to as many eligible people as possible. One dose of the monkeypox vaccine is 80% effective. Second doses will be administered when more vaccine is available.

Our goal is to get one dose into as many peoples eligible arms as possible, said Wilma Wooten, M.D., M.P.H., County public health officer. When we get more vaccine, we can start giving second doses for even higher efficacy.

Since late May, the County has received 4,687 doses of monkeypox vaccine. Of those, 3,251 have been distributed and 2,267 have been administered. The number administered might be higher because it takes a few days for the vaccine registry to be updated. As more doses are allotted to the region, the County will expand distribution.

For more information about monkeypox, visitthe Countys monkeypoxwebsite, which is updated at about 4 p.m. each weekday afternoon. To receive text messages about monkeypox, text COSD MONKEYPOX to 468-311.

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Monkeypox Vaccine: Where to Get It - countynewscenter.com

Eyegene said on Tuesday that it signed an agreement to develop a Japanese encephalitis virus gene-recombinant vaccine with financial support from the Korea Health Industry Development Institute (KHIDI).

The research and development cost is estimated to be 200 million won ($150,000), and the state agency will provide 150 million won, it said

This is not the first time that KHIDI has selected EyeGene to develop a Japanese encephalitis vaccine. The company conducted the immune-enhanced pentameric gene-recombinant Japanese encephalitis vaccine development study with the Catholic University of Korea from October 2020 to March 2022.

"Through this project, we will derive candidate substances for the gene-recombinant Japanese encephalitis virus vaccine, including the immune enhancer system, produce non-clinical prototypes, and evaluate the non-GLP non-clinical toxicity and effectiveness, a company official said.

The official added that the company would conduct follow-up studies to establish mass-production processes, good manufacturing practice (GMP) production, and good laboratory practice (GLP) non-clinical tests."

The vaccine immune enhancer system developed by this study is a technology applicable to various vaccines. According to the company, it can be further developed in combination with various vaccine antigens using recombinant protein antigens.

EyeGene said the company has also been conducting a study on the efficacy and effectiveness of its shingles vaccine, EG-HZ, with the governments support of 100 million won since July.

"Recently, vaccinations for shingles prevention are recommended both at home and abroad, and the need for homegrown vaccines to replace imported treatments is increasing, the company official said. We plan to strengthen competitiveness in this field by performing additional efficacy, safety, and stability assessment of our shingles vaccine."

EyeGene is pushing to license its shingles vaccine (EG-HZ) with foreign vaccine companies.

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EyeGene to conduct vaccine projects with government support - KBR

Japan from mid-October plans to administer a new type of vaccine in booster shots designed to protect people from the Omicron variant of the novel coronavirus, the health ministry said.

The bivalent vaccine will be made available to people who have received two doses of existing vaccines, starting with elderly people and those with underlying health conditions, according to the Ministry of Health, Labor and Welfare.

The central government, working together with local governments, will start preparations to eventually provide bivalent vaccine inoculations to the entire population.

The policy to use the new vaccine was approved at a ministry meeting on Aug. 8.

The ministry, based on the opinions of an advisory panel on responding to COVID-19, also decided to issue a recommendation in early September at the earliest that parents should make utmost efforts to vaccinate their children aged 5 through11 under the Preventive Vaccination Law. But the ministry will not make such inoculations compulsory.

The bivalent vaccine is designed to defend against BA.1, an Omicron subvariant, and an early strain of the novel coronavirus.

Pfizer Inc. and Moderna Inc. have been developing their versions of the bivalent vaccine.

Trial runs reportedly showed that the new vaccine is more effective than existing vaccines in producing neutralizing antibodies that can defend against an array of Omicron variants.

The U.S. companies said their new vaccines also offer better protection against BA.5, the Omicron subvariant that is now the dominant strain in Japan.

According to the results of clinical trials, the ministry estimates that the inoculation interval for the bivalent vaccine is about five months.

Pfizer on Aug. 8 applied for Japanese government approval for its bivalent vaccine. If granted regulatory approval, the new vaccine could be imported starting in September, according to the ministry.

Ministry officials said they expect no problems in securing enough doses of the new vaccine for all people who have received two shots of existing vaccines.

Japan is currently providing booster shots for certain segments of the population, including second boosters for health care workers and those 60 or older.

Some members of the expert panel urged the ministry to advise the population not to pass up the available vaccines because of the anticipated arrival of the new vaccine.

The existing vaccines now provide a certain degree of protection against the spread of the novel coronavirus, one of the members said. People should be fully informed not to shun them when they come at hand.

The ministry approved inoculations of children 5 through11 after it became clear that current types of vaccines can help to defend this age group against the Omicron family to some extent.

Data presented to the panel meeting on Aug. 8 showed that children in this age group have a low likelihood of developing serious symptoms during the two months after their second doses.

In addition, about 80 percent of infected children could avoid hospitalization if they are vaccinated, the panel said.

The panel also said no signs have been detected that raise concerns about the safety of the vaccines as long as their possible side effects are monitored.

Many panel members endorsed the ministrys recommendation to vaccinate this age group, noting that the number of infections among children has increased in recent months, and some are being listed in serious condition.

Children, in fact, represented a significant percentage of new COVID-19 cases in July, according to the ministry.

Children under 10 accounted for 14 percent of the new infections, while those aged 10 to 19 made up 16 percent of the total last month.

See the article here:

Japan plans booster shots of Omicron vaccine in October | The Asahi Shimbun: Breaking News, Japan News and Analysis -

Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative case-control study  The Lancet

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Vaccine effectiveness of two-dose BNT162b2 against symptomatic and severe COVID-19 among adolescents in Brazil and Scotland over time: a test-negative...

As concern about how to curb monkeypox continuesat a global level, the first few thousand vaccines against the disease have reached Victoria.

Unlike COVID-19 jabs, uptake of the monkeypox vaccine is not being widely encouraged, but rather directed at particular groups who are at highrisk of contracting the virus.

So far, there have been 22 cases of monkeypox in Victoria, with seven of those remaining active.

Most have been returned travellers, but one case resulted from local transmission.

Here's what we know about how the rollout will look.

Victoria has been allocated 3,500 doses of the third generation JYNNEOSsmallpoxvaccine, which is one of two smallpox vaccines approved for use in Australia.

Due to high demand for the vaccine globally, supply is quite limited.

A complete vaccination requires two doses, delivered at least 28 days apart via injection, preferably into the upper arm.

Advice from Australia's federal health department suggests that, although the vaccine is most effective when given prior to infection, vaccination within 14 days of exposure to monkeypox is expected to reduce the severity of the illness.

Receiving the vaccine within four days of exposure provides the highest chance of avoiding monkeypox altogether.

A similarrollout of the vaccine has begunin New South Wales this week, with the state allocated 5,500 doses.

Although the vaccines are being organised by the Commonwealth, it is up to individual states and territories to decide how to allocate doses based on local risk factors.

Victorian Health Minister Mary-Anne Thomas said the arrival of thefirst trancheof vaccinesfrom the Commonwealth was welcome, and the delivery of more was due later in the year.

Monkeypox can be picked up by anyone who has prolonged contact with another person with the virus, but at the moment the outbreak has disproportionately been affecting men who have sex with men.

Initial symptoms of monkeypoxcan include:

Symptoms are usually followed by a distinctive rash that may appear on the face, genitalia, inside the mouth, palms of the hands and soles of the feet.

The disease spreads between peoplethrough skin-to-skin contact, contact with infected surfaces oritems and respiratory droplets.

While health authorities wait for more supply, strict eligibility criteria for the vaccine have been decided.

MsThomas said vaccines would be "distributed to the people who need them most as quickly as possible".

Thismeans that, at this stage, those eligible are high-risk close contacts of existing monkeypox cases, lab workers analysing specimens from monkeypox cases,sexually active HIV positive or negative gay or bisexual menas well as sex workers with high-risk clients.

Men who have sex with men including cis and transgendermen who fulfil additional criteria set out by the health department will also be eligible.

The vaccine will be rolled out at a handful of Melbourne health clinics, and the Victorian health department's advice for those eligible in regional areas is that the vaccine may be available via a local public health unit.

Thoseclinics earmarked to be part of the rollout are the Melbourne Sexual Health Centre, Thorne Harbour Health, Northside Clinic, Collins Street Medical Centre and Prahran Market Clinic.

Those people eligible to be vaccinated due to their exposure to a confirmed monkeypox case will have their vaccination organisedby health authorities.

At the end of July, Australia's Chief Medical Officer labelled the increasing presence of monkeypox in the country a "communicable disease incident of national significance".

That move followed the World Health Organization's declaration that the spread of the virus to more than 70 countries represented a global "public health emergency".

The disease has beenassociated with west and central African countries since it was first detected in but, since May, it has spread around the world.

There have been more than 26,000 cases reported across the world, with the majority in the US and Europe.

See more here:

Monkeypox vaccines have arrived in Victoria. Here's how the rollout will work - ABC News

The University of Houston-Downtown (UHD) is the second-largest university in Houston and has served the educational needs of the nations fourth-largest city since 1974.

As one of four distinct public universities in the University of Houston System, UHD is a comprehensive, four-year university led by President Loren J. Blanchard. Annually, UHD educates more than 15,000 students, boasts more than 61,000 alumni, and offers 46 bachelors degrees, 11 masters degrees, and 17 fully online programs within four colleges: Marilyn Davies College of Business, College of Humanities & Social Sciences, College of Public Service, and College of Sciences & Technology.

For the fourth consecutive year, U.S. News & World Report ranks UHD among universities across the nation for Best Online Criminal Justice Programs(No. 27and No.15 for Veterans) and Best Online Bachelors Programs.

UHD has the most affordable tuition among four-year universities in Houston and one of the lowest in Texas. U.S. Newsranked the University amongTop Performers on Social Mobilityand awarded UHD aNo. 1 rankingas the most diverse institution of higher education in the southern region of the U.S.The Universityis noted nationally as a Hispanic-Serving Institution, Minority-Serving Institution, and Military Friendly School. For more on the University of Houston-Downtown, visitwww.uhd.edu.

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UHD, H-E-B Offering Students Bacterial Meningitis Vaccine On Campus With Deferred Payment Option - UHD News

Introduction

The pandemic impulse generated due to the infectious agent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) resulted in millions of infections and around six million deaths globally.1,2 As late as May 9, 2022, there were 755,415 cases reported and 9103 deaths in KSA at the hand of SARS-CoV-2.2 Vaccination is regarded the at most survivor from the pandemic. However, keeping with the data collected as late as May 4, 2022, 11,562,157,794 inoculations are reported to be administered worldwide.3 The earliest COVID-19 vaccine manufactured and approved was Pfizer-BioNTech/BNT162b2 which has the goal to hold off the pandemic. The experimental studies were completed in a short duration and were given Food and Drug Administration (FDA) approval just after a few months following its I or II clinical trials that were held in May 2020. The EUA (emergency use authorization) for this vaccine was granted in the last month of the year 2020. It received 23 August 2021 the full FDA approval, after passing all safety and efficacy requirements.4 Three approved companies whose doses are presently available in Saudi Arabia include Pfizer-BioNTech/BNT162b2, Moderna, and Oxford/AstraZeneca COVID19 vaccines.5,6 Among the currently approved COVID-19 vaccines, Pfizer-BioNTech/BNT162b2 and Moderna mRNA-1273 are based on mRNA technology.710

With the detection of novel viral variants, like Omicron, Delta, and Coronavirus Mu variant, there is a worry that the decline in immunity over time will diminish the potency; therefore, the third dose called booster may be required to boost immunity in fighting against new strains.8 After getting FDA approval, the CDC (Centre for Disease Control and Prevention) recommended a third dose for all aged 65 and above, and later the eligibility was expanded to other groups. The WHO-World Health Organization is also emphasizing an additional dose of the vaccine, to emphasize vaccine efforts to decrease the death rates and turn down the severity of disease, to protect the general maintenance of health.11 In Saudi Arabia, an additional dose was suggested for all who crossed the age of 16 and had completed their 2 doses. The Ministry of Health (MOH) Saudi Arabia created cognizance of the third dose booster dose through a campaign called Maintain Your Level with Booster Shot so as to achieve maximum immunity in the community.5

Vaccine hesitancy (VH), the biggest challenge to overcome and managing the pandemic, is elucidated as refusal or delaying its acceptance despite its availability.12 A research in the Kingdom of Saudi Arabia (KSA) has reported that the driving factor in hesitancy in accepting the inoculations of the vaccine was the concern over its efficacy and safety. It was revealed in a review that the inclined awareness about safe vaccines and being honest in reporting adverse effects could help in tackling the delay faced in vaccine acceptance and improving the uptake of immunization.13

Several studies from various other areas of the world reported fewer side effects after administrating the first or second dose, such as pain at the site of injection, swelling, tenderness, redness, warmth, itch, and swollen armpit glands, headache, fever, fatigue, night sweats, chills and shivering, joint pain, muscle pain, nausea, vomiting, and loss of appetite.1419 Despite the reality that the clinical studies assured the vaccine was safe and effective, it had limitations, such as a few participants recruited in the clinical studies and a healthier than real-world sample. This may neglect some less frequent deleterious effects that may happen. The vaccine developed in a short span and using new technology triggered a worry among people regarding its safety. Post-marketing evaluation is necessary to increase the public confidence in the vaccine and motivate them to accept the vaccine.10,2023

Keeping the limitations of clinical studies in mind, further epidemiological studies are important to evaluate the short-term COVID-19 side effects and to increase public trust in the safety and efficacy of the vaccine. Health professionals are recruited in the present study with the hope that the unwanted effects being reported by health practitioners will be accurate in comparison to the non-health professionals. Therefore, this research objective is to identify the short-duration side effects after receiving the Pfizer-BioNTech/BNT162b2 COVID-19 vaccine in health practitioners in the Eastern Province of the Kingdom of Saudi Arabia.

A descriptive cross-sectional study, conducted in the Eastern Province of Saudi Arabia, used a self-administered online survey to look for adverse reactions reported by healthcare workers (HCWs) who have received the booster dose of Pfizer-BioNTech/BNT162b2 vaccine. All vaccinated respondents who had taken their booster dose of Pfizer-BioNTech/BNT162b2 vaccine were requested for online surveys wherever the respondents stayed requested to selfreport some mildtomoderate indications that they developed post-vaccination. The target people of the current study HCWs (aged 18 to more than 55 years) were working in the Eastern Province, Saudi Arabia. The entitled respondents were to have taken their booster dose of the COVID19 vaccine prior to participating and filling in the survey questionnaire. Clinical (physicians, nurses, medical technicians, and pharmacists) and nonclinical (administrative and medical record professionals, and nonmedical technicians) HCWs serving at private and public hospitals in Eastern Province during the study time were the target populations of the current study. Respondents who had not taken booster doses as well as not HCWs were excluded from the study. The survey team identified the respondents (HCWs) from their professional and personal contact. Information was collected about those who were entitled and eager to participate in the survey. We followed STROBE guidelines for cross-sectional studies.24

In this study, we calculated the minimum sample size according to Lwanga and Lemeshow.25 Due to the absence of previous data on post-vaccination side-effects of COVID-19 booster dose among HCWs in Saudi Arabia, the <0.50 presumed quantity was used,26 through a 5% margin of error and 95% confidence level. A total of 384 participants were deemed necessary for this study based on the minimum number. However, as this study was based on an online survey disseminated via social media, it was decided to decrease the sampling bias in our method. We increased it to include 577 participants, which is near about 1.5-fold of the required size. During the study period, 580 eligible respondents participated in the study.

An appraisal of literature, including PubMed, Google Scholar, and other databases, was conducted with the goal of identifying short-term and potential sideeffects that might occur after the Pfizer-BioNTech/BNT162b2 vaccination. The questionnaire was designed using Google Forms and was written in English and Arabic. The final versions were reviewed by four different experts in the field to check for face and content validity. It was initially distributed to a pilot sample consisting of 10 participants to check for any technical misunderstandings or contraindications. The final data analysis did not include the pilot survey response. The survey was made as short in length as possible. It was clarified that the information would be used only for medical research purposes, as the participants were not identified and had the right to withdraw at any stage. An online survey using choice randomization displays answer options at random to the participants to avoid selection bias. Multiple sections were included in the questionnaire. A brief description of the purpose of the study is contained in the first section, along with contact details for the investigators, and an agreement for participants to consent to participate. The second section of the questionnaire was designed for the purpose of gathering general information about the respondents comprising age, sex, educational qualification, occupation, chronic diseases such as hypertension, diabetes mellitus, asthma, and others, in addition to whether they had, previous infection history with SARS-CoV-2 infection. The third section of the study focused on the COVID-19 vaccine, specifically sideeffects experienced after Pfizer-BioNTechs/BNT162b2 COVID-19 vaccine, their timing, and duration. Participants were able to leave the box unchecked if no symptoms were reported. There is a subsection with a list of the most frequently sideeffects reported in other studies,21,2729 redness at the site of the injection, pain at the site of the injection, body pain, fatigue, other, fever, chills, delayed menstruation, headaches, skin rashes, swelling at the site of the injection, nausea, and vomiting. Moreover, a section was provided for reporting other possible unpublished sideeffects. The study participants may have experienced. Further-more, participants were asked to report visits to doctors and any hospitalizations after vaccination, as well as any medications taken after vaccination. The target group for this study are HCWs working in the Eastern Province of Saudi Arabia. The survey team identified the respondents for the survey. The surveys link was disseminated to the respondents via WhatsApp, SMS, or e-mail and in individual to set a meeting. Survey/data collection has been performed from 7 March 2022 to 20 April 2022. Since all participants were asked to conduct the survey, members of the survey team identified and verified the responses of those who did not participate. Survey responses were provided by eligible participants based on their willingness to participate in the research.

Data for only those who had taken a booster dose of the Pfizer-BioNTech/BNT162b2 vaccine, respondents adherence with the inclusion and exclusion criteria and submitted a complete questionnaire. Of 577 participants, 74 (12.82%) individuals were excluded due to incomplete survey. Thirteen (2.25%) participants received the Moderna COVID-19 vaccine and were excluded from this study. In total, 490 (84.92%) respondents were included in the final analysis.

For conducting this study, we obtained ethical approval from the standing ethical review committee at Mohammed Al-Mana College for Medical Sciences (Reference number: SR/RP/80). We obtained the consent of all study participants before participation in the study. The study omitted responses with no informed consent, incomplete responses, those who failed to take a booster dose, respondents other than HCWs and those who taken a COVID-19 vaccine booster dose other than the Pfizer-BioNTech/BNT162b2 vaccine.

Statistical analysis was conducted using the data spread from Google Forms (Mountain View, California, USA) and Microsoft Excel (Version 2016), and then exported into Statistical Package for Social Sciences (SPSS) version 26.0 (IBM, Inc., Armonk, NY, USA). To depict the distribution of categorical variables, we used descriptive statistics such as occurrence, percentage, and mean standard deviation (SD), and to represent quantitative variables, we used median (interquartile range, IQR), respectively. ShapiroWilk tests were performed before the analysis to determine the normality of all quantitative variables. We cast off Pearsons chi-square (2) for examining the connotation amongst COVID-19 post-vaccination sideeffects and the independent variables (demographics and background features). MannWhitney U-tests and KruskalWallis tests were used to evaluate the number of COVID-19 post-vaccination adverse effects reported by the respondents as an ordinal dependent variable corresponding to the independent variables.

Additionally, a multivariate logistic regression investigation was conducted to determine the factors related to a complaint about sideeffects subsequent to administration of the PfizerBioNTech/BNT162b2 COVID-19 vaccine, which was coded as a replica reliant on variable (yes = 1 and no = 0). A multivariate ordinal logistic regression exploration was conducted to determine whether certain factors are associated with sideeffects following vaccination. A multivariate logistic regression model was created based on all variables that were associated with p 0.25 in univariate investigations.30 Odds ratios were calculated and intervals of confidence were calculated for all analyses. P-values were amended for multiple evaluations using the consecutive Bonferroni method (Bonferroni-Holm). Statistical significance was defined as p-values less than 0.05.31

Table 1 shows the general demographic characteristics of 490 vaccinated HCWs with the Booster dose of Pfizer-BioNTech/BNT162b2 vaccine participated in the study.

Table 1 General Demographic and Health Characteristics of the Participants (n = 490)

The mean SD age of the contributors was 33.836.91; more than half (56.74%, n = 278) of them were females, and 43.26% were males. Nurses were accounted for the majority of HCW group at 25.51% (n = 125), followed by Pharmacist (Medical) (18.37%, n = 90). Among all the HCW 29.18% (n = 143) have experienced between 1 and 2 years. Participants who had been previously diagnosed with COVID19 made up 32.86% (n = 161), most of whom were females (56.52%, 91/161). Only 8.37% (n = 41) of participants had reported suffering from a chronic disease.

As a result of this study, 81.84% (401/490) of the HCWs who took part described at least one post-vaccination side effect of COVID-19. There were 3 (14) reported side effects (median (IQR). Amongst the 401 HCWs who experienced postvaccination sideeffects of COVID19, Figure 1 displays that body pain (89%) and pain at the site of injection (88.73%) were the utmost frequent reported sideeffects, followed-by headache (28.68%), joint or bone pain (27.18%), muscle pain (26.43%), nausea or vomiting (21.2%), fever (18.95%), skin rashes (10.22%). On the other hand, the smallest often reported unwanted effects were redness at the site of injection (8.23), chills (7.98%), fatigue (7.73%), and swelling at the site of injection. However, 11.93% of the female respondents also reported delayed menstruation.

Figure 1 The frequency of COVID19 vaccine sideeffects reported among the participants (n = 401).

Participants who developed COVID-19 post-vaccination side effects were grouped according to their gender (Table 2). The results displayed that female HCWs had a meaningfully higher occurrence of side-effects of body pain (90.12% vs 87.34%; 2 = 18.37; p<0.001), pain at the site of the injection (89.30% vs 87.97%; 2 = 17.08; p = 0.001), swelling at the site of the injection (5.35% vs 2.53%; 2 = 4.76; p = 0.03), headache (89.30% vs27.85%; 2 = 6.33; p = 0.01), muscle pain (28.40% vs 23.42%; 2 = 9.66; p<0.001) and skin rashes (11.11% vs 8.86%; 2 = 6.33; p = 0.01) compared to male HCWs. On the other hand, the male HCWs had an ominously higher frequency of wholebody pain/fatigue (67.8%, 61/90) related to their female peers (50.0%, 80/160) (2 = 4.12; p = 0.04). Nonetheless, these significant differences were not retained when the BonferroniHolm adjustment was applied.

Table 2 Distribution of COVID19 Vaccine Sideeffects Reported Among the Healthcare Worker Participants According to Gender (n = 401)

In Table 3, we explore how COVID-19 vaccine side effects are associated with participant demographics and health background characteristics. HCWs developed side-effects at comparable frequencies (p = 0.001) among females (87.41%, 243/278) and males (74.52%, 158/221). There was substantial variance in the frequency of sideeffects consistent with participants age (<0.001) except >55 years age group. Interestingly, medical HCWs had a significantly lower frequency of unwanted effects than nonmedical HCWs (61.67% vs 80.73%; p = 0.001). Similarly, more than 5 years of experience significant side-effects (86.08%; p = 0.04) compared to another experience group of HCWs. There is no significant relationship between the history of comorbidities of COVID19 infection and side-effects experienced with the booster dose of vaccination. After BonferroniHolm correction, only two variables, sex, and occupation (medical) displayed a substantial link with the reporting of sideeffects.

Table 3 Associations of the Reported COVID19 Vaccine Sideeffects with the Participants Background Characteristics (n = 490)

In Table 4, we display the changes in the number of COVID-19 post-vaccination adverse effects stated by the deliberate HCWs according to self-governing variables. Medical HCWs have far fewer side effects (median = 4; IQR = 2, 3) as compared to nonmedical HCWs (median = 1; IQR = 1, 2) (U = 4148; p = 0.05) based on the MannWhitney U-test. Nevertheless, the KruskalWallis test did not show any significant differences in the number of side effects between age groups (H = 2; p = 0.36). As well, there were no significant differences in the number of side effects across variables (p > 0.05).

Table 4 Number of Sideeffects Reported by the Participants Following the Booster Dose of COVID19 Vaccine According to the Participants Background Characteristics (n = 401)

In Table 5, we present the results of multivariate logistic regression analysis for the factors accompanying reporting side-effects following the booster dose of the COVID19 vaccine among the HCWs. All variables that displayed relations with p 0.25 in the univariate analysis are available in Table 3. HosmerLemeshow test, cast-off for the inferential goodness-of-fit test, indicated the model fitted the data well (2 = 13.584; p = 0.317). The results revealed that a history of chronic diseases had a 0.44fold increased risk of side-effects compared to no history of chronic diseases health care workers (adjusted odds ratio (aOR) = 0.44; 95% CI = 0.224, 0.880), and a significant association of occupation with side-effects was also 1.61-fold increased risk compared to nonmedical ((aOR) = 1.61; 95% CI = 1.037, 2.513). Though, the substantial connotation of the year of experience with side-effects was not maintained in the multivariate analysis (p = 0.418).

Table 5 Multivariate Analysis of Factors Associated with Reporting of Sideeffects Following COVID19 Vaccine Among the Participants (n = 401)

Moreover, Table 6 provides the multivariate ordinal logistic regression analysis results for the factors prompting the number of COVID-19 vaccine side-effects described by the studied health care workers. Table 4 presents a univariate analysis that showed differences with a probability of p 0.21; all variables that showed a difference were included in the model. The model had a good fit and was statistically significant (2 = 19.254, p < 0.001). In the current study, the rate of stated side-effects was meaningfully predisposed by HCW gender and history of COVID-19 infection. The results indicated that holding other variables unchanged, a history of COVID-19 infection was fewer expected to report a greater number of side-effects than no history of COVID-19 infection (aOR = 17.410; 95% CI = 0.575, 1.974; p < 0.001). Likewise, female respondents were less likely to report a greater number of side-effects than male contributors (aOR = 5.164; 95% CI = 0.116, 1.576; p = 0.023).

Table 6 Results of Ordinal Logistic Regression for the Factors Associated with the Number of Reported Sideeffects Following the COVID19 Vaccine (n = 401)

Period and controlling of the described COVID19 vaccine sideeffects among the health care workers who developed COVID19 post-booster dose vaccination sideeffects, 77.81% (312/401) of the testified sideeffects happened on the day of getting the vaccine (Day 0). In contrast, 16.21% and 5.49% of the stated sideeffects happened on Day 1 and Day 2 post-vaccination (the second and third postvaccination days of booster dose), correspondingly. However, only 0.50% HCWs reported side effects appeared after day 2 of a post-booster dose of vaccination. The period of informed sideeffects was 12 days for 58.35% (n = 234) and 35 days for 25.94% (n = 104), while the sideeffects lasted for more than 5 days for only 7.73% (n = 31) of the subcategory of members who reported unwanted effects. Furthermore, 3.0% (n = 12) of those who experienced sideeffects go to a doctor, and medicine for a post-booster dose of vaccination sideeffects was taken by 83.79% (n = 336). Only 1.5% HCWs (n=6) were admitted to the hospital for less than 24 hours; however, only 0.50% (n = 2) were admitted to the hospital for 2436 hours (Table 7).

Table 7 The Onset, Duration, and Management of COVID19 Vaccine Sideeffects Were Reported Among the Participants in the Study (n = 401)

Presenting transparently the possible side effects post-vaccine administration is an approach to keeping trust in the vaccines and maximizing the benefits of vaccines safely. Subsequently, populations fears against vaccines could be dissipated. In this context, the current research sheds light on the prevalence of Side-Effects related to mRNA-based COVID-19 Vaccine booster dose among HCWs in the Eastern Province of Saudi Arabia.

The outcomes of the current study revealed a high incidence of side effects among the respondents where 81.84% of them have stated the minimum of one side-effect post-COVID-19 vaccine booster dose. This is consistent with data from other studies examining the safety of booster dose.32 However, compared to a previous study for first and second doses in which short-term sideeffects of Pfizer-BioNTech/BNT162b2 in individuals age span between 18 and 70 years old were investigated, fewer overall sideeffects (40%, n = 208) were recorded.33

Our findings show that body pain (89%) and injection site pain (88.73%) were typically indicated sideeffects by the HCW respondents, similar to the data publicized by Phase 3 clinical trial with the Pfizer-BioNTech/BNT162b2 vaccine revealed that pain at the injected site was the prevalent complication (7183%). However, in contrast to findings of the stated clinical trial where fatigue was the second reported side-effects (3447%), our data show fatigue was among the least frequently reported side effects (7.73%).34 We found higher values for delayed menstruation indicated by female participants (11.93%) than those reported by Edelman et al in the USA (4.3%).35

Our results corroborate with previous studies where a genderrelated variance in describing adverse events after numerous vaccines. It was detected a vigorous inflammatory and immune responses to vaccines in females as opposed to males, which could elaborate the genderbased variances response toward vaccinations.36 Additionally, behavioral, genetic, and hormonal elements could trigger the divergence in adverse events after vaccination between genders.37,38

Remarkably, the contemporary paper revealed that medical profession participants showed an important connotation with the reporting of sideeffects, which concurs well with the findings of a study done by Darraj et al in Saudi Arabia.39 Medical HCWs were more likely than nonmedical HCWs to detail a higher figure of side effects. These could be related to the medical and scientific background of medical HCWs about vaccine safety, which would improve their capacity to recognize and distinguish manifestations.39

Contrary to several earlier reports indicating that people with prior exposure to COVID-19 infection detailed more side effects, our results do not seem to confirm their observation.20,34,40 In fact, no significant relations with history of COVID19 infection and side effects experienced with the booster dose of vaccination were noted in our study. However, a noteworthy link between increased reporting side effects and participants having a history of chronic diseases was noted and also confirms previous findings in Germany.41

In this study, 77.81% of the reported sideeffects happened on vaccination day (0 day), which is in agreement with the results stated in other comparable studies.33,42 In the present investigation around 83.79% of the respondents were on medications (chiefly analgesics) to lessen the side effects. Analgesics are commonly used by Saudi Arabians both currently working in healthcare and those not in healthcare to ease the COVID-19 vaccines side effects.43 Moreover, just 3% of the respondents necessitated seeing a physician owing to sideeffects from the vaccines, and only 2% of the respondents were hospitalized. This will fully endorse the vaccines safety.

As a result of the present study, we can add more social confidence related to the safety of the COVID-19 Pfizer-BioNTech/ BNT162b2 vaccine, allowing to speed vaccination coverage. The transparent reporting of side effects by health care workers is especially central for accepting vaccinations for the general public. This is because people are more likely to be vaccinated when directed by a healthcare professional.44

However, our study is not without limitations. First, a self-administered online survey was used to assemble the data, which could result in a reporting bias and quite a small sample size. We chose an online study because we wanted to guarantee participants safety, due to the COVID-19 pandemic, SARS-CoV-2 viruses, and the recommendation to continue social distancing as a precaution measure in Saudi Arabia. In addition, conducting community-based surveys would be difficult during this pandemic. Thus, we collected our data online through a self-reported survey, and it was distributed based on the authors networks. Another limitation of the current study is that it observed the vaccines short-term side-effects (from day 0). Vaccine effects on our cohort are still unknown in both the short- and long-term. Likewise, side effects subsequent to the booster dose of the vaccine were investigated, whereas the side-effects post the first and second dose of the vaccine were not studied. Additionally, the participants were only Pfizer-BioNTech/BNT162b2 recipients. Therefore, more multicentred investigations with bigger sample sizes are necessary to confirm the different COVID-19 vaccines safety profiles permitted in the country as well as, forthcoming studies to assess other rare events such as thromboembolic profiles and myocarditis and to confirm the immunogenicity of the booster doses are also important.45

The current research comes up with relevant information regarding the side effects that can occur post-COVID-19 vaccine administration amongst HCW in the Eastern Province of Saudi Arabia. The outcomes indicated that most respondents had body pain and site injection pain, whereas fatigue is among the least reported side-effects post-booster dose. The female respondents also report delayed menstruation, but it would be necessary to collect extensive data from a large number of vaccinated populations to assess any significant association between delayed menstruation and the COVID-19 vaccine. Additionally, occupations related to healthcare were highly connected with more reporting of sideeffects. Self-medication practice to alleviate side-effects due to the vaccination is clearly manifested in the. Overall, the outcomes pointed to entirely tolerable mild to moderate reported COVID19 postbooster dose vaccination sideeffects. Consequently, the existing studys findings reinforce the vaccines safety and offer main standard facts to rise healthcare workers and the general communitys awareness of the predictable sideeffects subsequent COVID19 vaccines. This could convince the reluctant, refusal persons and pessimists to receive the booster dose COVID19 vaccine.

There is no funding to report.

The authors have no conflicts of interest to declare in this work.

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