Category: Covid-19 Vaccine

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

FDA announced on Oct. 19, 2023 that it had issued the final guidance, Development and Licensure of Vaccines to Prevent COVID-19, to help sponsors with the clinical development and licensure of COVID-19 vaccines. The document does not address every consideration for satisfying requirements because some vaccines may need specific data, according to the agency. The final guidance reflects FDAs current thinking on the issue.

Given the need to ensure that sponsors are aware of our current recommendations to facilitate timely development of vaccines to prevent COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 371(h)(1)(C)), and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agencys good guidance practices, the agency stated in the document.

The final guidance explains key considerations for chemistry, manufacturing, and controls including facilities and inspections; nonclinical data, such as toxicity studies; clinical trials, such as trial populations and trial design; post-licensure safety evaluations; and diagnostic and serological assays. In addition, the guidance discusses other safety considerations that should be addressed including demonstrating effectiveness, surrogate endpoints, and adequate datasets. If it is no longer possible to demonstrate vaccine effectiveness by way of conducting clinical disease endpoint efficacy studies, the use of a controlled human infection model to obtain evidence to support vaccine efficacy may be considered. However, many issues, including logistical, human subject protection, ethical, and scientific issues, would need to be satisfactorily addressed, FDA stated in the guidance.

Source: FDA

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FDA Finalizes Guidance on Development of COVID-19 Vaccines - Pharmaceutical Technology Magazine

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Updated Pfizer vaccine now available through the Health Department - Columbia Missourian

The season of flu, colds and COVID-19 is upon us, and its time for people to stay up-to-date on vaccines to stave off the severity of sickness.

We believe these inoculations have saved lives by reducing the severity of symptoms and curbed the spread of viruses. The pandemic unfortunately and unsafely turned trusted science into politicized tests. But, to prevent escalating illness, people who can get the vaccines ought to consider keeping their shots updated.

The U.S. Centers for Disease Control and Prevention recommends updated COVID-19 vaccines for those 5 and older. For children 6 months to 4 years, the vaccines can be dispensed in multiple doses. For influenza, the CDC recommends a vaccine for everyone 6 months and older. The CDC states it is safe to get the vaccines at the same time.

For people at high risk for serious illness from these diseases, getting the vaccines is particularly important, as stated in a press release by Tulsa Health Departments Interim Associate Director of Preventive Health Ellen Niemitalo.

This includes people who are 65 years of age and older, people with underlying health conditions and pregnant women. Vaccines are safe and effective, and they have been proven to help prevent serious illness, hospitalization and death. COVID-19 vaccines also reduce the chance of suffering the effects of Long COVID, which can develop during or following acute infection and last for an extended time.

Though the emergency measures of the pandemic arent necessary, COVID-19 still poses danger to vulnerable populations.

A recent CDC report shows the over-65 age group represents 63% of all COVID-related hospitalizations from January through August. The vast majority of these patients had two or more underlying health conditions, including obesity, diabetes, asthma or chronic lung disease, sickle cell disease and immunocompromised disorders.

Notably, only 24% of those hospitalized were fully up to date on their coronavirus vaccinations, including boosters. So far this year in the U.S., nearly 90% of people who have died from COVID-19 were over 65. Also, this age group makes up 61% of intensive care unit admissions.

The flu doesnt get as much attention, but it affects millions annually with deadly possibilities for at-risk groups.

Being vigilant about vaccinations will keep our greater community healthy. Consistent handwashing is always important, and masks are another option for people with concerns about spreading viruses. Everyone plays a part in keeping others safe.

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Immunizations keeping community safe: Opinion - Tulsa World

Why do some people experience reactions to a vaccine while others dont? Everybodys immune system has unique characteristics, and that can influence how people may respond to a vaccine. What people are experiencing can be multifactorial. It can be a function of what else is going on in their lives. Maybe theyre more tired or stressed, or maybe they had another recent infection that their immune system is already responding to.

Age also can play a role. In larger COVID-19 vaccine studies, people below the age of 55 tended to have more reactions like fever, fatigue, headache, and muscle aches, and that may have to do with how vigorous the immune system is. As you get older, your immune system tends to quiet down a bit.

With this current vaccine, what we are hearing is that for the vast majority on a large population level, the side effects are on par with previous doses and people arent feeling any worse from the updated shot.

Its also important to remember that we are in flu season, along with other respiratory viruses circulating in addition to COVID-19. If symptoms last longer than a day or two, people may think the vaccine is the reason theyre getting sick or testing positive for COVID, but its likely a separate infection or theyre developing symptoms concurrently.

Do more vaccine symptoms mean more protection? Id caution against the idea that there is no protection if there is an absence of symptoms like pain, mild fever, or fatigue.

There are some studies that show that people have higher antibody levels when they have strong symptoms after vaccination, but the majority of people make antibodies after the vaccine. The differences that we see are not substantial enough to make us worry about lack of protection.

Should you take a pain reliever before the vaccine to prevent any symptoms? I dont recommend taking a pain reliever like ibuprofen or acetaminophen prior to the vaccine as a standard process, but would rather someone take one afterward if theyre feeling any pain or headache.

How can you treat COVID-19 vaccine side effects at home?

When should someone see a doctor if theyre experiencing any vaccine-related symptoms? Typically, someone can expect to experience symptoms for a day or two. But if the pain isnt going away or its getting worse after that time frame, get in touch with a healthcare provider.

Allergic reactions are very rare, but if someone has trouble breathing, persistent pain or pressure in their chest after getting the vaccine, they should contact their physician.

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Common Side Effects of the Updated COVID-19 Vaccine - Health Matters

Suffolk County reported the following information related to COVID-19 on October 19, 2023

According to CDC, hospital admission rates and the percentage of COVID-19 deaths among all deaths are now the primary surveillance metrics.

COVID-19 Hospitalizations for the week ending October 14, 2023

Daily Hospitalization Summary for Suffolk County From October 19, 2023

NOTE: HOSPITALS ARE NO LONGER REPORTING DATA TO NYSDOH ON WEEKENDS OR HOLIDAYS.

Fatalities occurring in Suffolk County (Data showing fatalities by place of residence is archived as of 10/12/23 and is no longer being updated)

COVID-19 Case Tracker October 17, 2023

Note: As of May 11, 2023, COVID-19 Community Levels (CCLs) and COVID-19 Community Transmission Levels are no longer calculatable, according to the Centers for Disease Control and Prevention.

* As of 4/4/22, HHS no longer requires entities conducting COVID testing to report negative or indeterminate antigen test results. This may impact the number and interpretation of total test results reported to the state and also impacts calculation of test percent positivity. Because of this, as of 4/5/22, test percent positivity is calculated using PCR tests only. Reporting of total new daily cases (positive results) and cases per 100k will continue to include PCR and antigen tests.

COVID-19 Vaccination Information

Last updated 5/12/23

Vaccination Clinics

As of September 12, 2023, the Suffolk County Department of Health Services is not authorized to offer COVID-19 vaccines to ALL Suffolk County residents.

The department will offer the updated vaccine to only uninsured and underinsured patients through New York State's Vaccines for Children program and Vaccines for Adults program, also known as the Bridge Access Program.

Those with insurance that covers the COVID-19 vaccine are encouraged to receive their vaccines at their local pharmacies, health care providers offices, or local federally qualified health centers.

The department has ordered the updated COVID-19 vaccine and will announce when the vaccine becomes available.

FOR HEALTHCARE PROVIDERS

New York State Links

CDC COVID Data Tracker Rates of laboratory-confirmed COVID-19 hospitalizations by vaccination status

For additional information or explanation of data, click on the links provided in throughout this page.

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COVID-19 update 10-19-23 - Suffolk County Government (.gov)

Imran Mirza, a health specialist and global lead for UNICEFs COVID-19 Program, applauded the expedited vaccine rollout, but said the pandemic exposed many health systems weak infrastructure to handle patient overflow and mitigate burnout for health workers.

This is the time to build up those systems and whats required such as human resources, Mirza said, noting the world is still in a pandemic. We need to start thinking about this now. All the risk is not gone, its still there.

But the speedy arrival of COVID-19 vaccines, which were developed in less than one year, also holds lessons for future vaccine rollouts, the panelists noted. Wenhui Mao, Ph.D., assistant director of programs for the Duke Global Health Innovation Center, says the expediency of the vaccine allowed it to reach vulnerable populations much sooner. On average, some vaccines can remain in the research and development stage for up to a decade.

Imagine if we could reduce this time by years, she said. It could save lives and protect people. Lots of innovative practice was used to promote the COVID-19 vaccine.

Chizoba Wonodi, Ph.D., an associate scientist of global disease epidemiology and control at the Johns Hopkins Bloomberg School of Public Health, focused on where people received vaccine doses. In addition to hospitals, public health leaders turned facilities such as stadiums into vaccination sites and deployed mobile vaccination clinics to provide access for rural patients.

Fixed posts are important to get people to vaccination sites, Wonodi said, adding theres still room for flexibility in that area. Solutions for this can be more options for walk-in shots and arranging internet access [to make appointments] for those who need it.

Udayakumar highlighted the importance of discussing COVID-19 holistically, through all phases of testing, treatment and immunization, as a guide for how the world can respond to future health crises.

Understanding what happened from an end-to-end perspective will allow us to take some of these lessons to heart, he said. And be better in everything we do moving forward.

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Lessons From the COVID-19 Vaccine Rollout - Duke Global Health Institute

Although it hasnt felt much like fall around the desert just yet, the cooler temperatures will surface eventually. To prepare for the flu season, the Coachella Valley Unified School District is hosting their annual flu and COVID-19 vaccine clinic, open to the public.

According to the California Department of Public Health, the 2023-2024 flu season started on October 1st, and with COVID-19 still lingering around, CVUSD wants to make sure that all residents are prepared.

Well, we feel its important that everybodys safe during the flu season. The flu is expected to hit hard this year, so we want to offer this again to everybody so that they remain safe during the flu season. Lawrence Luna says, the Director of Risk Management for the Coachella Valley Unified School District.

The district is partnering with Desert Healthcare to help make this flu and COVID-19 vaccine clinic, free of charge, and open to all.

This is open to students, staff and the entire community. The flu is expected to hit hard this year, so we want to offer this again to everybody so that they remain safe during the flu season. Luna says.

The clinic takes place at the Thermal Senior Center, October 21st, from 9 a.m. to 12 p.m.

As far as what to bring to the clinic, They bring their insurance card if they have insurance, be there on time, please be patient. We do expect a good crowd for this, so if they come just bring your right or left arm and be ready to roll your sleeves up and get your vaccination. Luna adds.

Overall, CVUSD wants all Coachella Valley residents safe, this flu season.

We feel its extremely important for everybody to be vaccinated. We want to invite the entire community out here. Please come and get vaccinated in preparation for the flu season. We want everybody to be safe. We want our students in school, we want our staff in classrooms in front of the teacher, and we want our community safe as well. Luna says.

Again, everyone is welcome to the vaccine clinic at the Thermal Senior Center, with most services free for those without insurance.

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CVUSD To Host Flu and Covid-19 Vaccine Clinic At Thermal Senior ... - NBC Palm Springs

Evidence suggests that protective antibodies against SARS-CoV-2 can pass from mother to fetus.

Evidence suggests that protective antibodies against SARS-CoV-2 can pass from mother to fetus.

In a study funded by the National Institute of Allergy and Infectious Diseases (NIAID), researchers found that people who received a primary COVID-19 vaccine dose or an additional booster dose while pregnant generated protective antibodies against SARS-CoV-2 in both their own blood and the umbilical cord blood, which suggests that the protective antibodies reached the fetus.

The Multisite Observational Maternal and Infant Study for COVID-19 (MOMI-VAX) launched in June 2021 to research how COVID-19 vaccination affects the immune systems of pregnant people. The study includes the results from 240 participants: 167 who received the two-dose primary series of an mRNA COVID-19 vaccine while pregnant and 73 who also received a booster dose. (At the time of the study, only one booster dose was recommended. The study closed in early 2022.)

To measure protective antibody levels, the researchers analyzed blood samples gathered before participants received the primary vaccine series or an additional booster, after the vaccination or booster, and at the time of delivery. A sample of umbilical cord blood was also gathered at delivery to measure antibodies that crossed the placenta.

The researchers found that pregnant people who received the COVID-19 vaccines generated antibodies against SARS-CoV-2 variants, including Omicron. Antibodies were also found in the cord blood, which suggests that the newborns also received protection against SARS-CoV-2. Study participants who received a booster dose had more antibodies in their blood and cord blood samples than those who received the primary series.

Research has shown that COVID-19 vaccination is safe and effective for pregnant people. Pregnant people are more likely to have severe COVID-19, and the disease increases their risk for preterm birth. Infants under 6 months of age are also at increased risk for severe COVID-19, and they are not eligible to get vaccinated.

This research supports COVID-19 vaccination, especially with booster doses, during pregnancy for the protection of pregnant parents and newborns. Future research can examine the best time during pregnancy to receive their first COVID-19 vaccine dose or a booster dose for the most protection.

More Evidence That COVID-19 Vaccination While Pregnant Likely Protects Children

COVID-19 Vaccination and Boosting During Pregnancy Benefits Pregnant People and Newborns

COVID-19 Vaccines While Pregnant or Breastfeeding

Munoz, F. M., Posavad, C. M., Richardson, B. A., Badell, M. L., Bunge, K. E., Mulligan, M. J., Parameswaran, L., Kelly, C. W., Olson-Chen, C., Novak, R. M., Brady, R. C., Pasetti, M. F., Defranco, E. A., Gerber, J. S., Shriver, M. C., Suthar, M. S., Coler, R. N., Berube, B. J., Kim, S. H., , & DMID 21-0004 Study Group. (2023). COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn. Vaccine, 41(36), 5296-5303. https://doi.org/10.1016/j.vaccine.2023.06.032

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SARS-CoV-2 Antibodies From Vaccination During Pregnancy May ... - National Institutes of Health (NIH)

Moha El-Jaw / iStock

A new Centers for Disease Control and Prevention-led study finds that people with HIV (PWH) have higher COVID-19 reinfection rates than those without HIV (PWOH).

The study, published yesterday in Emerging Infectious Diseases, involved 453,587 adults in Chicago infected with SARS-CoV-2 from their first infection through May 2022. The investigators matched COVID-19 test results and vaccination data to Chicago's Enhanced HIV/AIDS Reporting System.

"HIV can compromise the immune system; persons with HIV (PWH), especially those not receiving antiretroviral therapy (ART), might be vulnerable to SARS-CoV-2 infection," the researchers wrote. "Understanding how COVID-19 affects PWH is important because approximately half of PWH are>50 years of age and have higher rates of medical comorbidities, compared with persons without HIV (PWOH)."

A total of 5.3% of the 453,587 COVID-positive residents were reinfected, including 192 of 2,886 (6.7%) PWH and 23,642 of 450,701 (5.2%) PWOH. Reinfection rates among PWH were 66 per 1,000 person-years, compared with 50 of 1,000 person-years among PWOH. PWH had a higher adjusted rate of COVID-19 reinfection (1.46 per 1,000 person-years) than PWOH.

Among reinfected residents, PWH were older (median age, 43 years) than PWOH (36 years). Relative to PWOH, PWH were more likely to be men (79.3% vs 40.9%) and Black (53.7% vs 27.0%) and to have received a primary COVID-19 vaccine series and booster (31.8% vs 22.1%). Of those reinfected, PWH were less likely than PWOH to be unvaccinated at their first infection (87.5% vs 91.0%).

PWH should follow the recommended COVID-19 vaccine schedule, including booster doses, to avoid SARS-CoV-2 reinfections.

Of 131,682 residents vaccinated before their first SARS-CoV-2 infection, 54.2% had completed a primary Pfizer/BioNTech vaccine series. Of 23,834 reinfected residents, 39.6% (9,444 of 23,834) had completed a primary series but had not received a booster before reinfection.

Regardless of variant wave and calendar quarter, PWH consistently had a higher rate of reinfection than PWOH. The highest incidence for PWH occurred during Omicron strain predominance (50 cases per 1,000 person-years). Overall, an excess of 16 reinfections per 1,000 person-years were reported among PWH.

"PWH should follow the recommended COVID-19 vaccine schedule, including booster doses, to avoid SARS-CoV-2 reinfections," the authors wrote.

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COVID-19 vaccine uptake in pregnancy linked to previous vaccine ... - University of Minnesota Twin Cities