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No adverse booster shot events found in LTC residents; vaccines potent against omicron, studies reveal

No adverse booster shot events found in LTC residents; vaccines potent against omicron, studies reveal



A study across 239 Genesis HealthCare nursing homes has found no evidence of adverse reactions to COVID-19 booster shots among residents. The news arrives alongside results from two new studies showing current booster efficacy against the omicron variant.

Investigators from Brown University and Genesis compared rates of adverse events between nursing home residents who had received an mRNA COVID-19 vaccine booster dose and their peers who had yet to receive a booster. The primary mRNA vaccine series was delivered at least six months before Sept. 22, 2021 and participants’ third booster doses were given between that date and February 2, 2022.  

“No safety signals were detected,” in a 14-day post-vaccination period, reported veteran nursing home researcher Vincent Mor Ph.D., and colleagues.

Quick immune response

Another study, published Thursday in the journal Nature, may help answer the question of how effective these boosters are against omicron. Study participants given three doses of an mRNA vaccine were able to quickly produce antibodies against the variant, researchers from The Rockefeller University in New York reported. 

“These data help explain why a third dose of a vaccine that was not specifically designed to protect against variants is effective against variant-induced serious disease,” they wrote.

A cohort study published Friday, meanwhile, has found a “persisting and robust” immune response to omicron mutations in patients with different vaccination histories. 

“The results mean that both vaccination and previous infection with COVID-19 likely prevent severe illness and death from the omicron strain,” reported the Center for Infectious Disease Research and Policy.

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Third Pfizer booster dose has mild side effects

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Attendance plummets at LA covid vaccination events

Attendance plummets at LA covid vaccination events

Nurse Angel Ho-king sways her head to the sound of salsa music as she waits for people willing to roll up their sleeves to get a shot. Ho-king is part of a four-person crew staffing a covid-19 vaccine table at a health fair in Rampart Village, a predominantly immigrant neighborhood about 10 minutes from Dodger Stadium.

In three hours on a recent Saturday, Ho-king and Brenda Rodriguez, a medical assistant, vaccinated 16 people — far fewer than they had anticipated. Nearly everyone who showed up at the fair, organized by Saban Community Clinic, was an adult seeking a booster shot or a young child getting a first dose (children ages 5 to 11 became eligible for a vaccine late last year).

As covid infections have declined so too has interest in covid vaccines — even though the shots are highly effective at preventing serious illness and death from the virus.

In California’s most-populous county, where more than 1.7 million people have not received even one dose, vaccination events have turned desolate. About 46,000 county residents got their first dose in March, a 79% decline from January, according to the Los Angeles County Department of Public Health.

Those who remain unvaccinated are harder to convince, telling health care workers and vaccination coordinators that they don’t feel a sense of urgency.

According to a January survey by the Public Policy Institute of California, about 1 in 10 California adults said they definitely won’t get vaccinated, which has remained consistent since January 2021, and 86% of unvaccinated adults said the omicron variant wasn’t enough to persuade them. Employers and businesses are dropping or rolling back vaccination mandates. And although proof of vaccination once offered perks like allowing people to go maskless indoors, face coverings are generally no longer required in California.

At a recent vaccination drive coordinated by an immigrant advocacy group in Palmdale, near Lancaster in northern LA County, only two people showed up over four hours, both for second doses. As of April 1, 25% of Palmdale residents ages 5 and up were unvaccinated, compared with 17% of county residents, according to county data.

Jorge Perez, Salva Organization‘s vaccine coordinator, spent a week promoting the event with his team, going door to door, visiting local businesses, and publicizing it on social media. At previous vaccine drives, “we got 42 people, then 20, then four,” said a disappointed Perez. “Now two.”

Perez reduced the number of staffers at vaccination events from five to two in February as the numbers started to dwindle.

Much work remains to be done to combat vaccine misinformation, especially given the spread of BA.2, an omicron subvariant that is highly transmissible, said Dr. Richard Seidman, chief medical officer for L.A. Care, a public Medicaid insurance plan that serves county residents. The number of covid cases and hospitalizations had been declining since February, but the county is again seeing a bump in cases, according to data released this week.

People have various reasons for remaining unvaccinated, Seidman said. “For some, it’s distrust of the government or health care providers in general,” he said. “Some are more cautious and want to take a wait-and-see approach. Others simply don’t believe the science.”

A study published April 11 by JAMA Internal Medicine shows just how entrenched views are. Many people who refused to get vaccinated early on said they were waiting for the shots to get full approval from the FDA. But when the agency’s first full approval of a covid vaccine came in August 2021, the study concluded, it did little to change people’s minds and “had little immediate impact on vaccination intentions.”

In California, unvaccinated people were nearly 14 times as likely to die from covid as people who had been fully vaccinated and received a booster dose, according to state data from March 7-13.

Perez said people getting their first shots now are doing so mainly because they feel obligated — to meet a work requirement, for example, or enter places such as restaurants, bars, and gyms that require proof of vaccination.

That was the case for Modesto Araizas, one of the two people who showed up at the Palmdale vaccine event. Despite contracting covid twice, missing work, and having a hard time breathing, he didn’t get vaccinated until he needed proof of vaccination to eat at his favorite seafood restaurant.

“I haven’t been scared,” said Araizas, 46. “I take vitamins, eat healthy food, and I work out.”

Until recently, the federal government reimbursed doctors, hospitals, and other providers for tests, treatments, and vaccines for uninsured people. But the Health Resources and Services Administration stopped accepting reimbursement claims for tests and treatments March 22, and for vaccinations April 5.

Many uninsured people now will likely need to pay out-of-pocket for tests and other services.

Perez is hoping people might become more open to vaccines if covid tests become too expensive for them. No one will want to keep paying for tests when they can just get a shot, he reasoned.

Nurse Roxanna Segovia works at a pop-up vaccine and testing clinic in front of South LA Cafe in South Central LA. She recently spent 45 minutes trying to persuade a man who had visited the clinic regularly for free tests to get vaccinated.

“He gave me all the reasons he has not been vaccinated, like his civil rights were being violated and Bible verses,” Segovia said. “His job requires it now, and he said he was losing money by missing work waiting for test results. If he continued this way, he wouldn’t be able to feed his family, but even so, he still wasn’t sure if he was making the right choice.”

At the end of their conversation, he got the shot.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.




Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Third doses of COVID-19 vaccines not associated with increase in reports of serious adverse events: study

Third doses of COVID-19 vaccines not associated with increase in reports of serious adverse events: study

A new study looking at data concerning around 48,000 people in the U.S. has found that third doses of mRNA vaccine, such as those from Pfizer or Moderna, are safe and did not cause any increase in reporting of serious adverse events.

The study, published in the journal JAMA Network Open on Thursday, found that third doses did not result in an increase in severe adverse events compared to earlier doses, but did come with an increase in low-severity adverse events, such as fatigue and nausea.

“Results from this cohort study suggest that a third dose of the same type of vaccination after a BNT162b2 or mRNA-1273 primary series is associated with safe outcomes,” the study stated.

The COVID-19 vaccines produced by Pfizer-BioNTech and Moderna were originally designed as two-dose regimes, supported by extensive clinical trials. As studies showed evidence of waning vaccine immunity, health experts began to suggest booster shots, which were found to be safe and effective. But there is still less data on these third doses than on the first and second doses, a gap in knowledge that researchers were hoping to close in this new study. 

Researchers accessed electronic medical records provided by 47,999 adults within the Mayo Clinic Enterprise, a non-profit hospital system in the U.S., all of whom who were vaccinated with three doses of the same mRNA COVID-19 vaccines between December 2020 and Oct. 17, 2021.

Around 38,000 participants received the Pfizer-BioNtech vaccine for their three doses, while around 9,900 received the Moderna vaccine.

There were more than twice the amount of immunosuppressed individuals in the group who received Moderna than in the group that received Pfizer. No adverse events specific to a certain brand was reported in the study.

The most common adverse events after receiving the third dose were fatigue, the temporary swelling of lymph nodes, nausea and headache, with these symptoms reported by around two to five per cent of participants.

Less than two per cent of participants reported other common side effects such as joint pain, muscle aches, diarrhea and fever.

These numbers, while still small, represented a significant increase in how often these same participants had reported these side effects after their first or second dose.

After the third dose, two patients had anaphylaxis, four patients had a swelling of tissue around the heart called pericarditis and one patient reported myocarditis, meaning only 0.01 per cent of participants reported one of these serious adverse events.

“Reporting of severe adverse events was rare after the third dose and was not significantly increased compared with the frequency of reporting after the second dose,” the study stated.

Researchers also monitored emergency department visits for participants within two days of receiving each dose of the vaccine, and found that there was an increase in emergency department visits after a third dose of the Pfizer vaccine compared to the second. Overall, 0.29 per cent of people visited the emergency department after a third dose versus 0.2 per cent after the second dose.

There was no difference in ER visits for different doses for those receiving Moderna.

The overall results indicate that third doses are indeed safe, as they don’t come with an increase in severe adverse events, researchers said. They added that third doses had a better safety profile in this study than receiving a single dose did.

“Individuals who received exactly [one] dose of an mRNA-based COVID-19 vaccine had greater increases in incidence of adverse events after dose [one], compared with baseline, than what was observed in the [three]-dose cohort,” the study stated.

Researchers noted that there are limitations to the study, such as the fact that people receiving mixed brands were not included and that those receiving third doses are more likely to be older and immunosuppressed, thus potentially having a reduced immune reaction to the vaccine that could show less adverse effects.

Further studies into third doses will hopefully be able to flesh out more on the safety profile of mixing vaccine brands to further narrow down how frequent rare adverse events are, the study stated. 

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Impact of SARS-CoV-2 Omicron and Delta variants on serious hospital events

Study: Serious hospital events following symptomatic infection with Sars-CoV-2 Omicron and Delta variants: an exposed-unexposed cohort study in December 2021 from the COVID-19 surveillance databases in France. Image Credit: PHOTOCREO Michal Bednarek/Shutterstock

In a recent study posted to the medRxiv* pre-print server, a team of researchers assessed the differences in risk of hospitalization in adults after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron and Delta variants of concern (VOCs).

Study: Serious hospital events following symptomatic infection with Sars-CoV-2 Omicron and Delta variants: an exposed-unexposed cohort study in December 2021 from the COVID-19 surveillance databases in France. Image Credit: PHOTOCREO Michal Bednarek/ShutterstockStudy: Serious hospital events following symptomatic infection with Sars-CoV-2 Omicron and Delta variants: an exposed-unexposed cohort study in December 2021 from the COVID-19 surveillance databases in France. Image Credit: PHOTOCREO Michal Bednarek/Shutterstock


The emergence of the SARS-CoV-2 VOCs, Delta, and Omicron necessitated extensive research about the manifestations of the variants. The varied effects of the VOCs on adult patients, including the severity of disease and COVID-19-related hospitalizations, have been comprehensively studied. However, several studies suggest significant differences in the impact of the different variants on the occurrence of serious hospital events.    

About the study

The present retrospective cohort study investigated the differences and the various factors involved in COVID-19-related hospital events occurring in adults infected with SARS-CoV-2 Omicron and Delta VOCs.

COVID-19 cases in France between 6 December 2021 and 7 Jan 2022 were recorded and grouped into two arms – Delta and Omicron arms. The cases eligible for the study were of patients over 18 years of age, who had symptomatic manifestations of COVID-19 and were reverse transcription-polymerase chain reaction (RT-PCR) positive for SARS-CoV-2. Among the eligible cases, patients suspected to be infected with the Omicron VOC and the Delta VOC were known as exposed and non-exposed individuals, respectively.

The two groups were compared based on known risk factors like age, gender, the status of vaccination, and comorbidities. The study considered intensive care unit (ICU) admission of the COVID-19 patient, requiring critical care, or, death of the patient in the hospital as a serious hospital event.  

A multiplex quantitative RT-PCR (RT-qPCR) was used to characterize the variant present in the SARS-CoV-2-positive samples. The results of the mutation screening were evaluated based on the presence of spike proteins, characteristic to either Delta or Omicron VOC. The primary outcome of the study was the number of COVID-19-related serious hospital events among symptomatic patients who had tested positive for the SARS-CoV-2 Omicron or Delta VOC.        

Results

The study results showed that a total of 149,064 patients were included in the research. A total of 36% of patients in the SARS-CoV-2 Delta VOC cohort were unvaccinated as compared to the 17% of patients in the Omicron VOC arm. A slightly higher number of comorbidities was observed in the Delta arm than in the Omicron arm.

During the follow-up period of the study, 497 serious hospital events were observed, of which the Delta arm accounted for 447 cases while the Omicron arm had 50 cases. ICU admission was the most common serious hospital event.

Within the Delta VOC arm, 92% and 97% of the serious hospital events were observed within 14 and 21 days of SARS-CoV-2 detection while in the Omicron cohort, 84% and 100% of the serious events were observed within 14 and 21 days of the positive COVID-19 test, respectively. Notably, patients who were vaccinated with the booster dose had a higher number of serious hospital events as compared to the patients vaccinated with the primary dose.

Patients belonging to the age group of 18 to 79 years were at 7.7 times lower risk of serious hospital events in the case of Omicron symptomatic patients as compared to the Delta symptomatic patients. In patients 80 years and older, Omicron-infected patients had a 3.3-fold lower risk of serious events than patients infected with Delta. It was also noted that the odds of occurrence of a serious event increased with the increasing age of the patient. Also, male patients were at a significantly higher risk of serious events than women; this risk was lesser in vaccinated individuals.

The risk of serious hospital events was lowered by 6.7 times in vaccinated patients of ages between 18 and 79 years, irrespective of whether they received the booster vaccine or not, while the same risk was lowered by 2.2 times in patients of ages over 80 years who had received the primary vaccine dose; the risk was further reduced by 4.3 times when the patients received the booster dose.  

Conclusion

The study findings showed that the SARS-CoV-2 Omicron VOC has lower disease severity and a lower incidence of serious hospital events as compared to the Delta VOC. Despite the lower vaccine efficacy reported against the Omicron VOC as compared to the Delta VOC, no significant difference was observed in the protection provided by the vaccines against severe hospital events in this study.

According to the authors, the higher risk of occurrence of serious events in the elderly can be lowered with vaccination and booster dose administration.

*Important notice

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.