Category: Covid-19 Vaccine

Groundbreaking University of Limerick, Ireland research has revealed for the first time that loneliness and social stresses can have a negative impact on our antibody response to COVID-19 vaccines.

In a world's first, a group of UL researchers have found that lower neighborhood cohesion is associated with antibody response to COVID-19 vaccines.

This is important as the more antibodies a person makes, the better the level of protection against hospitalization and death from COVID-19.

The research team have demonstrated in a study published in the prestigious journal Brain, Behaviour and Immunity, that lower social cohesion also made people feel lonelier, and this was an additional factor in reducing COVID-19 vaccine responses.

Social cohesion is the degree of social connectedness and solidarity among different community groups within a society, including levels of trust and connectedness between individuals and across community groups.

Professor Stephen Gallagher, lead author and director of the study of anxiety stress and health lab at UL, said that low social cohesion was "a social stressor and we have known for a long time that these psychosocial stressors can have damaging effects on immunity in general but also antibody responses following vaccination, which we have demonstrated previously. Thus, it made sense to explore antibody responses to COVID-19 vaccinations".

Using data from over 600 people who took part in the UK's Understanding Society COVID-19 antibody study in March 2021, the researchers examined whether factors such as social cohesion and loneliness had a negative impact on people's antibody responses to the COVID-19 vaccine.

The authors found that lower social cohesion was predictive of a lower response to a single-shot of the COVID-19 vaccine; that those who felt less connected to their neighborhood, had lower trust in their neighbors, and felt unsupported or less similar to their neighbors, made fewer antibodies in comparison to those who reported higher social cohesion.

In addition, those who reported lower social cohesion also tended to report that they felt lonelier, and this, in turn, reduced their antibody response.

Professor Orla Muldoon, who was a member of the Irish National Public Health Emergency Team (NPHET) advisory group on behavior and communication and was a co-author of the paper, said that these results highlight once again the relevance of public trust and social cohesion to the success of our pandemic response.

"Public and neighborhood trust, social cohesion, and loneliness have all come to the fore during the pandemic," explained Professor Muldoon.

"For example, during the initial lockdowns a sense of being in it together was an oft used mantra. We had 'clap for carers' in the UK, Italians singing from balconies, Dubliners playing bingo in the flats, all of which increased social cohesion and public trust.

"These feelings of social cohesion and trust were short-lived; something UK researchers now call the 'Dominic Cummings effect'. Similar diminishing levels of trust were also seen in the US during these periods. Along with this, lockdowns brought social risks such as less social interaction and an increased risk of loneliness.

"As well as the findings of this study showing their role in antibody responses, trust and cohesion have also been shown to drive compliance with public health guidelines and vaccine uptake," added Professor Muldoon.

Dr Siobhn Howard, a co-author on the study, added that loneliness was a "well-established risk factor for several health conditions, with immune suppression a likely underlying pathway. Thus, this study adds to the growing body of evidence linking loneliness to poor health".

Source:

Journal reference:

Gallagher, S., et al. (2022) Social cohesion and loneliness are associated with the antibody response to COVID-19 vaccination. Brain Behavior and Immunity. doi.org/10.1016/j.bbi.2022.04.017.

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Loneliness and social stress can have negative impact on COVID-19 vaccine antibody response, study reveals - News-Medical.Net

(Stacker) - The vaccine deployment in December 2020 signaled a turning point in the COVID-19 pandemic.

By the end of May 2021, 40% of the U.S. population was fully vaccinated.

But as vaccination rates lagged over the summer, new surges of COVID-19 came, including Delta in the summer of 2021, and now the Omicron variant, which comprises the majority of cases in the U.S.

The United States as of May 27 reached over 1 million COVID-19-related deaths and nearly 83.8 million COVID-19 cases, according to Johns Hopkins University.

Currently, 66.6% of the population is fully vaccinated, and 46.6% of vaccinated people have received booster doses.

Stacker compiled a list of the counties with highest COVID-19 vaccination rates in Kentucky using data from the U.S. Department of Health & Human Services and Covid Act Now.

Counties are ranked by the highest vaccination rate as of May 26, 2022.

Due to inconsistencies in reporting, some counties do not have vaccination data available.

Keep reading to see whether your county ranks among the highest COVID-19 vaccination rates in your state.#50. Simpson County, KY

- Population that is fully vaccinated: 50.9% (9,451 fully vaccinated)

--- 11.6% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 512 (95 total deaths)

--- 43.8% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 30,729 (5,707 total cases)

--- 1.6% more cases per 100k residents than Kentucky#49. Logan County, KY

- Population that is fully vaccinated: 51.1% (13,859 fully vaccinated)

--- 11.3% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 469 (127 total deaths)

--- 31.7% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 31,001 (8,402 total cases)

--- 2.5% more cases per 100k residents than Kentucky#48. McLean County, KY

- Population that is fully vaccinated: 51.2% (4,718 fully vaccinated)

--- 11.1% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 587 (54 total deaths)

--- 64.9% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 28,706 (2,643 total cases)

--- 5.1% less cases per 100k residents than Kentucky#47. Mason County, KY

- Population that is fully vaccinated: 51.2% (8,741 fully vaccinated)

--- 11.1% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 621 (106 total deaths)

--- 74.4% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 29,678 (5,066 total cases)

--- 1.8% less cases per 100k residents than Kentucky#46. Muhlenberg County, KY

- Population that is fully vaccinated: 51.3% (15,714 fully vaccinated)

--- 10.9% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 402 (123 total deaths)

--- 12.9% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 33,496 (10,257 total cases)

--- 10.8% more cases per 100k residents than Kentucky#45. Washington County, KY

- Population that is fully vaccinated: 51.4% (6,213 fully vaccinated)

--- 10.8% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 513 (62 total deaths)

--- 44.1% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 33,055 (3,998 total cases)

--- 9.3% more cases per 100k residents than Kentucky#44. Magoffin County, KY

- Population that is fully vaccinated: 51.4% (6,255 fully vaccinated)

--- 10.8% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 428 (52 total deaths)

--- 20.2% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 32,654 (3,971 total cases)

--- 8.0% more cases per 100k residents than Kentucky#43. Grayson County, KY

- Population that is fully vaccinated: 51.7% (13,659 fully vaccinated)

--- 10.2% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 511 (135 total deaths)

--- 43.5% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 30,548 (8,073 total cases)

--- 1.0% more cases per 100k residents than Kentucky#42. Henderson County, KY

- Population that is fully vaccinated: 51.7% (23,355 fully vaccinated)

--- 10.2% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 372 (168 total deaths)

--- 4.5% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 31,079 (14,051 total cases)

--- 2.8% more cases per 100k residents than Kentucky#41. Fleming County, KY

- Population that is fully vaccinated: 52.0% (7,587 fully vaccinated)

--- 9.7% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 418 (61 total deaths)

--- 17.4% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 27,474 (4,006 total cases)

--- 9.1% less cases per 100k residents than Kentucky#40. Hopkins County, KY

- Population that is fully vaccinated: 52.0% (23,253 fully vaccinated)

--- 9.7% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 571 (255 total deaths)

--- 60.4% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 33,717 (15,067 total cases)

--- 11.5% more cases per 100k residents than Kentucky#39. Estill County, KY

- Population that is fully vaccinated: 52.1% (7,353 fully vaccinated)

--- 9.5% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 362 (51 total deaths)

--- 1.7% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 29,370 (4,143 total cases)

--- 2.9% less cases per 100k residents than Kentucky#38. Rowan County, KY

- Population that is fully vaccinated: 52.4% (12,829 fully vaccinated)

--- 9.0% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 286 (70 total deaths)

--- 19.7% less deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 27,792 (6,798 total cases)

--- 8.1% less cases per 100k residents than Kentucky#37. Caldwell County, KY

- Population that is fully vaccinated: 52.5% (6,696 fully vaccinated)

--- 8.9% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 479 (61 total deaths)

--- 34.6% more deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 32,745 (4,174 total cases)

--- 8.3% more cases per 100k residents than Kentucky#36. Nelson County, KY

- Population that is fully vaccinated: 52.5% (24,288 fully vaccinated)

--- 8.9% lower vaccination rate than Kentucky

- Cumulative deaths per 100k: 335 (155 total deaths)

--- 5.9% less deaths per 100k residents than Kentucky

- Cumulative cases per 100k: 31,770 (14,688 total cases)

--- 5.1% more cases per 100k residents than Kentucky#35. Leslie County, KY

- Population that is fully vaccinated: 52.6% (5,191 fully vaccinated)

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Counties with the highest COVID-19 vaccination rate in Kentucky - WBKO

Jefferson Health New Jersey was awarded a $574,503 grant from the New Jersey Department of Health.

The grant will be used to establish an outreach program to provide education, as well as COVID-19 vaccinations and boosters, to a wide array of community members in southern New Jersey. It will also be used to fund and train a team of social workers and community health workers to connect with various segments of the population throughout Camden and Gloucester counties and provide education and needed vaccinations.

Although New Jersey has one of the highest COVID-19 vaccination rates in the nation, there are still communities and subpopulations where rates remain under 70%.

Only 53.2% of residents of Gloucester County and 50.4% of residents of Camden County have received a booster shot.

The grant will fund education and vaccinations for more than a dozen communities in Camden and Gloucester counties. Specific areas of attention will include children ages 5 and up; women who are planning to become pregnant, are pregnant or are breastfeeding; people with intellectual or developmental disabilities; and homebound community members.

Jefferson Health New Jersey is proud to lead outreach efforts to engage vulnerable, undervaccinated communities in Camden and Gloucester counties, Amanda Kimmel, vice president of ambulatory operations for the Jefferson Medical Group in New Jersey, said. By ensuring equitable access to vaccines, we can help to lessen the disproportionate impacts of the pandemic for underserved populations, and prevent widening disparities while achieving broader population immunity.

Jefferson Health said it anticipates administering some 1,340 vaccines at hospital-based sites, outpatient locations and pop-up clinics. As the program expands, it is expected that flu shots will also be provided.

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Jefferson Health NJ awarded $574,503 grant to expand education and access to COVID-19 vaccines - ROI-NJ.com

American Rescue Plan Act Covid-19 relief funds

$24 billion is promised to New York state and local governments through the American Rescue Plan Act

Peter Carr, Rockland/Westchester Journal News

New York's statewide COVID-19 case countfell by 36.5% last week, signalingthat a spring wave caused by severalomicron subvariants is subsiding.

The state added45,469 new cases in the week ending Sunday, down from the previous week's tally of 71,647 new cases of the virus that causes COVID-19.

New York ranked 22nd among the states where coronavirus was spreading the fastest on a per-person basis, a USA TODAY Network analysis of Johns Hopkins University data shows.

The trends in New York casesin recent weeks suggested that a COVID-19 wave, which began in early April and was fueledbyhighly contagious omicron subvariants,wasrecedingin upstate counties and movingdownstate, causing upticks there.

Now, cases are fallingstatewide, with both urban and rural regions showing double-digit declines.

Still,32out of New York's 62 countiescountiesfellintothe high-risk COVID-19 category, of as Thursday,due to local infection rates and strains on hospitals, according to the Centers for Disease Control and Prevention. That's down from 54counties deemed high risk a week ago.

State and federal health officials urged people to wear masks indoors in public spaces in all counties within the high-risk category, regardless of vaccination status,to help curb the virus' spread.

"It is important that we don't let our guard down and continue to use the tools we have available to us to stay safe and healthy,"Gov. KathyHochul said in a statement Friday."The best way to protect yourself and your loved ones from serious illness is to get vaccinated and keep up to date with your booster doses."

Regulators have taken several steps in recent weeks to strengthen vaccination and booster rates nationally, including recommending a booster earlier this monthfor ages 5-11,at least five months after their initial vaccination series.

Meanwhile, Pfizer-BioNTech's COVID-19 vaccine appears to be safe and effective for children ages 6 monthsto 5 years, according toa company study released last week.The report suggested regulators could soon approve the vaccine for the youngest age group after months of delays.

In the latest week, coronavirus cases in the United States decreased 11.3% from the week before, with 702,236 cases reported. With 5.84% of the country's population, New York had 6.47% of the country's cases in the last week.

Across the country, 32 states had more cases in the latest week than they did in the week before.

More on COVID-19 in NY: New York COVID cases up 5%. NYC, Long Island face worst outbreaks as upstate wave recedes

NY nursing homes and COVID: 35,600 nursing home complaints flooded NY amid COVID. Here's what happened to each one

Across New York, cases fell in 58 counties, with the best declines in:

>> See how your community has fared with recent coronavirus cases

New York ranked 7th among states in share of people receiving at least one shot, with 90.2% of its residents at least partially vaccinated. The national rate is 77.7%, a USA TODAY analysis of CDC data shows. The Pfizer and Moderna vaccines, which are the most used in the United States, require two doses administered a few weeks apart.

In the week ending Wednesday, New York reported administering another 172,494 vaccine doses, including 22,063 first doses. In the previous week, the state administered 215,423 vaccine doses, including 26,428 first doses. In all, New York reported it has administered 39,323,243 total doses.

Within New York, the worst weekly outbreaks on a per-person basis were in:

The Centers for Disease Control says high levels of community transmission begin at 100 cases per 100,000 per week.

Weekly case counts rose in three counties from the previous week. The worst increases from the prior week's pace were in Bronx, Kings and Richmond counties.

In New York, 150 people were reported dead of COVID-19 in the week ending Sunday. In the week before that, 168 people were reported dead.

A total of 5,414,434 people in New York have tested positive for the coronavirus since the pandemic began, and 68,955 people have died from the disease, Johns Hopkins University data shows. In the United States 83,984,644 people have tested positive and 1,004,733 people have died.

>> Track coronavirus cases across the United States

USA TODAY analyzed federal hospital data as of Sunday, May 29.

Likely COVID patients admitted in the state:

Likely COVID patients admitted in the nation:

Hospitals in 34 states reported more COVID-19 patients than a week earlier, while hospitals in 33 states had more COVID-19 patients in intensive-care beds. Hospitals in 35 states admitted more COVID-19 patients in the latest week than a week prior, the USA TODAY analysis of U.S. Health and Human Services data shows.

The USA TODAY Network is publishing localized versions of this story on its news sites across the country, generated with data from Johns Hopkins University and the Centers for Disease Control. If you have questions about the data or the story, contact Mike Stucka at mstucka@gannett.com.

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NY COVID cases plummet 36.5% as omicron wave recedes - The Journal News

--Phase 1 clinical trial will evaluate safety and immunogenicity of several formulations of SCB-2020S as a 2-dose vaccination series in adults--

--SCB-2020S to further validate the use of Trimer-Tag as a plug-and-play technology platform and bolster Clovers COVID-19 vaccine pipeline--

SHANGHAI, China, May 31, 2022 (GLOBE NEWSWIRE) -- Clover Biopharmaceuticals, Ltd.(Clover; HKEX: 02197), a global clinical-stage biotechnology company developing novel vaccines and biologic therapeutic candidates, today announced the first participants have been dosed in a Phase 1 clinical trial to assess the safety and immunogenicity of several formulations of SCB-2020S.

SCB-2020S is a second generation, potentially broadly protective COVID-19 vaccine candidate based on a chimeric Beta and prototype trimeric SARS-CoV-2 S-protein, preserving potential neutralization epitopes across multiple variants of concern (VOCs) of SARS-CoV-2, including Omicron. Clover intends to explore how the SCB-2020S constructcould further expand the breadth of vaccine-induced neutralizing antibodies to address the existing and potential new variant strains of the SARS-CoV-2 virus.

As new COVID-19 variants emerge, it is critical we continue to develop variant-adapted and potentially broadly protective COVID-19 vaccines to stay one step ahead of this highly contagious virus. The clinical evaluation of SCB-2020S will further demonstrate the proof-of-concept for variant strain change utilizing our Trimer-Tagtechnology platform, said Dr. Nicholas Jackson, President of Global Research and Development of Clover.

The Phase 1 trial is a double-blind, randomized, dose-finding study that will evaluate the safety and immunogenicity of SCB-2020S with CpG 1018/alum and CAS-1 adjuvants respectively. CAS-1 is Clovers proprietary oil-in-water emulsion-based adjuvant system developed in-house. The active comparator will be Clovers prototype COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). All vaccine formulations will be administered as a two-dose regimen, given 21 days apart to approximately 150 adults (18 to 75 years of age) in South Africa. Initial safety and immunogenicity data from the trial is expected in the second half of 2022.

Dr. Peng Liang, Founder and Chief Scientific Officer of Clover and inventor of Trimer-Tagtechnology added, We are thrilled to see the first participants dosed in this Phase 1 study, which marks another significant milestone on our journey to providing the world with much-needed solutions to address the future of this evolving COVID-19 pandemic utilizing our Trimer-Tagtechnology platform. We are also excited to bring CAS-1 our in-house oil-in-water emulsion adjuvant into the clinical trial stage and believe it could become a powerful tool used across our portfolio of Trimer-Tag vaccine candidates.

The evaluation of SCB-2020S will help inform Clovers future COVID-19 vaccine development strategy. Clover remains focused on completing regulatory submissions to the NMPA, the EMA, and the WHO for SCB-2019 (CpG 1018/Alum) as well as preparing for commercialization in China and around the world as the highest priorities and will continue to leverage the Trimer-Tag technology platform to create variant-specific and broadly protective COVID-19 vaccines.

About SCB-2020SEmploying the Trimer-Tag technology platform, Clover developed the SCB-2020S antigen, a stabilized trimeric form of the SARS-CoV-2 Spike (S) protein based on the receptor-binding domain (RBD) of the Beta variant and the N-terminal domain (NTD) of the original strain. This chimeric S-protein preserves potential neutralization epitopes across multiple variants of concerns (VOCs) of SARS-CoV-2, including Omicron. Clover will evaluate SCB-2020S with CAS-1, an in-house developed oil-in-water emulsion-based adjuvant, to further inform the development of the COVID-19 prophylaxis platform and adjuvant development programs.

About Clover BiopharmaceuticalsClover Biopharmaceuticals is a global clinical-stage biotechnology company committed to developing novel vaccines and biologic therapeutic candidates. The Trimer-Tag technology platform is a product development platform for the creation of novel vaccines and biologic therapies. Clover leveraged the Trimer-Tag technology platform to become a COVID-19 vaccine developer and created SCB-2019 (CpG 1018/Alum) to address the COVID-19 pandemic caused by SARS-CoV-2.

For more information, please visit Clovers website:www.cloverbiopharma.comand follow the company onLinkedIn.

Clover Forward-looking StatementsThis press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used in this [document], the words aim, anticipate, believe, could, estimate, expect, going forward, intend, may, might, ought to, plan, potential, predict, project, seek, should, will, would and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements.

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. Participant to the requirements of applicable laws, rules and regulations, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements contained in this document are qualified by reference to this cautionary statement.

Clover Biopharmaceuticals:

Cindy MinSVP, Public Affairsmedia@cloverbiopharma.com

Naomi EichenbaumVP, Investor Relationsinvestors@cloverbiopharma.com

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Clover Doses First Participants in Phase 1 Trial with SCB-2020S, a Potentially Broadly Protective Chimeric COVID-19 Vaccine Candidate - GlobeNewswire

10th District Legislators Introduce Resolution Urging Congress to Reinstate Military Members Discharged for Refusing COVID-19 Vaccine

Senator Jim Holzapfel and Assemblymen Greg McGuckin and John Catalano have introduced a resolution which urges Congress to reinstate U.S. service members who were forcibly discharged from duty in response to COVID-19 vaccine mandates. This resolution comes in response to several Marines from Ocean County who were discharged for opting out of the vaccine which prompted Congressman Chris Smith to introduce H.R. 7570.

Our military service members have given so much to preserve our freedoms and they should not be punished for making a personal medical decision, stated Senator Holzapfel. Our legislation is urging Congress to do the right thing and allow the brave men and women of our nation the opportunity to continue their service while receiving the benefits they rightfully deserve.

COVID-19 vaccinations became mandatory for members of the Armed Forces in 2021.Those service members who did not wish to receive a vaccine were discharged, in some cases with a general discharge under honorable conditions. These discharges may create issues for future employment, interfering with their ability to serve the country and possibly reducing their eligibility for certain benefits.

Enough with the political games that are damaging the livelihoods of our service members, added Assemblyman McGuckin. We can all agree that the promises weve made to the members of our Armed Forces should be upheld and those seeking to be reinstated have the opportunity while maintaining their benefits. In addition, taxpayers have paid billions to train our fully volunteer military branches and we should not just throw away that investment.

This concurrent resolution would reinstate service members to their previous rank and grade, upon their request and change the discharge of an individual to honorable.

We are ashamed at the lack of respect for the men and women who have sacrificed so much for the love of their country, continued Assemblyman Catalano. The vaccine mandates forced upon our Armed Forces are part of a political agenda which have ruined thousands of military careers. Those that are dismissed should be able to honorably continue serving their country and have their records rightfully restored, without question.

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10th District Legislators Introduce Resolution Urging Congress to Reinstate Military Members Discharged for Refusing COVID-19 Vaccine - InsiderNJ

Sars-CoV-2 continues to infect millions of people worldwide and cause an estimated 10,000 deaths per day, as the US alone approaches one million dead. It is widely expected to become endemic, remaining in circulation for the foreseeable future, and continuing to cause substantial numbers of hospitalisations and deaths, especially among vulnerable groups. Covid kills about tenfold more people than flu, based on historical information, says Penny Ward, professor of pharmaceutical medicine at Kings College London, UK.

Existing vaccines reduce the probability of severe disease, but do not protect against infection. Immunity also wanes within months, particularly against the newest emerging variants. This leaves room for companies to develop more effective antivirals and vaccines in the coming months or even years.

There are now three drugs to fight the virus directly: two taken orally and one intravenous. Pfizers Paxlovid (nirmatrelvir/ritonavir) inhibits a viral protease enzyme, and the tablets can reduce hospitalisation and death by around 60% when taken early. Lagevrio (molnupiravir), from Merck & Co and Ridgeback Therapeutics, mimics an RNA building block and introduces catastrophic errors in viral RNA. It can cut the risk of hospitalisation or death by around 30%.

But both have issues. Paxlovid includes ritonavir, which has pharmacogenetic boosting effects, notes Ward, but is incompatible with medications for heart disease, diabetes and other conditions. Molnupiravir cannot be given to pregnant women or children. Theyre not the perfect antivirals, says Ward. While the third option Gileads Veklury (remdesivir) might lower the risk of hospitalisation or death by 87%, it must be given intravenously. That leaves plenty of scope for new antivirals. Mortality following hospital admission is between 25 and 40%, depending on the frailty of the individual, says Ward. Rapid diagnosis and prescription is also important for the drugs to be effective, which may be problematic as countries cut down access to testing.

There are a few candidate antivirals in development. Atea Pharmaceuticals has a polymerase inhibitor, bemnifosbuvir (AT-537), that it continues to pursue, despite a setback with a phase 2 trial with mild-to-moderate patients that brought a collaboration with Roche to an end in October. They are rejigging the trial design and continuing with development, says Ward. Meanwhile, Japanese biotech Shionogi has a protease inhibitor (S-217622) in phase 2a trials.

I think omicron is going to carry us from pandemic to endemic, but we dont know how much pathogenicity an endemic Sars-CoV-2 will carry

Since antivirals target internal proteins, which do not mutate as much as the spike protein targeted by antibodies, they are expected to hold up well against new variants, and possibly even other coronaviruses. Ward expects strong demand for effective antivirals, to the point where governments would stockpile these treatments, in the same way as flu antivirals. This offers a lucrative market for anyone with large quantities of new, improved antivirals. The US government has bought around 3.1 million courses of molnupiravir, for approximately $2.2 billion, for example.

But supply is likely to continue to be an issue. Molnupiravir is formulated as a powder-filled capsule. There are relatively few capsule filling lines and these have lower production than tablet lines, says Ward. Presently, neither [Merck nor Pfizer] can produce enough of these drugs to be able to supply the world, says Ward. Most governments will retain them for use in the highest risk population.

Although the mRNA vaccines from Moderna and Pfizer-BioNTech have dominated in wealthy countries, the New York Times vaccine tracker lists 12 fully approved vaccines, 19 in early or limited use, and 38 in phase 3 efficacy trials. And there are good reasons for them to continue. There are significant limitations with the current vaccines, says Kingston Mills from Trinity College Dublin in Ireland. They dont produce sterilising immunity, meaning they dont prevent infection. He notes that antibody levels drop after each dose, although some of the vaccines seem to induce stronger long-term T-cell memory responses. There is room for the development of vaccines that have better local immunity and better immune memory, he concludes. He is optimistic that this can be done.

We have vaccines that are very effective against serious disease and stopping people from ending up in hospital and dying, but they arent very good at preventing people from getting infected

Some see the initial slow pace of vaccine coverage to poorer regions as an inevitable result of government decisions. The international Covax initiative to distribute vaccines to lower income countries has faced a barrage of broken promises, delays and logistical difficulties. All policy makers cared about was speed and innovation, says Peter Hotez, vaccinologist at Baylor College of Medicine in Houston, US. They got what they paid for: interesting vaccines for smaller populations in the northern hemisphere. Early vaccine shipments went to those willing to pay top dollar. But leaving parts of the world unvaccinated has proven risky. Hotez points to the delta and omicron variants both coming out of unvaccinated populations in India and southern Africa, respectively.

Hotez began a coronavirus vaccine programme almost a decade ago, first for Severe Acute Respiratory Syndrome (Sars) after 2012 and then for Middle East Respiratory Syndrome (Mers). When Covid-19 came along, he was ready to develop a vaccine based on the receptor binding domain on the spike. This recombinant protein plus adjuvant vaccine (Corbevax) was licensed to the Indian company Biological E in 2020, and later showed 90% efficacy in phase 3 trials, gaining emergency authorisation in India in late December 2021. It relies on standard yeast fermentation to make its recombinant protein. The technology is similar to that used to make recombinant hepatitis B vaccine, says Hotez, meaning it can be made locally in countries such as India, Bangladesh, Vietnam and Brazil. There are no patents, no strings attached, with ownership transferred to the development country vaccine manufacturer. It should be easier to store than mRNA vaccines and, being an older technology, perhaps reassure people hesitant about newer vaccines, he adds.

Other protein-based vaccines are making progress, with Novavax the first to gain approval. Sanofi and GSK began a phase 3 study of their recombinant protein vaccine last summer, announcing preliminary booster results in December and intention to file for regulatory approval this February. Recombinant protein vaccines have different manufacturing requirements than the viral vector, mRNA or live attenuated viral vaccines, which broadens the range of manufacturing facilities available to make more vaccines.

Other vaccine developers remain confident that their candidates have advantages that will earn them a place in the Covid-19 vaccine market. Canadian company Medicago is growing vaccines in Nicotiana benthamiana a close relative of tobacco. Young plants are inoculated with a modified agrobacterium that induces them to produce the Sars-CoV-2 spike protein. After a few weeks, the plants are processed to harvest virus-like particles from the leaves. They are the same shape, size and exterior appearance as the native virus, which is one of the reasons we think they are so immunogenic, says Brian Ward, medical officer at the company. The finished vaccine, dubbed Covifenz, also includes GlaxoSmithKlines immune response-boosting adjuvant ASO3.

In trials, Covifenz was around 70% effective against the delta variant in December 2021, and was approved in late February by Health Canada. Medicago sees much of its sales in the booster market and is shortly starting a trial in patients who already received other approved vaccines. However, the World Health Organization decided against accepting it for emergency use, owing to the companys links to the tobacco industry Medicago is 33% owned by Philip Morris International.

If we want to prevent symptomatic disease, then we will have to give boosters very frequently, six-monthly or perhaps even three-monthly

Other companies are also targeting boosters. US biotech firm Arcturus Therapeutics has developed an mRNA vaccine (ARCT-021) that is self-amplifying. Whereas the mRNA in approved Covid-19 vaccines makes spike protein for a day or two, Arcturus mRNA churns out spike for one to two weeks. Chief executive Joseph Payne explains that this means the dose can be significantly reduced, to 5g per dose, compared to 30g for PfizerBioNTech and 50g for Moderna.

A lower dose means less RNA is injected, meaning less of the other ingredients in the formulation as well. The key side effects with vaccines are attributed not to the mRNA but to the [other] ingredients, says Payne, so he hopes to see a more attractive safety profile. Also, production should stretch much further, in theory allowing the firm to manufacture more doses at lower cost than other mRNA vaccines. Arcturus has manufacturing agreements in place in the US, Japan and Europe, and is building a production facility in Hanoi, Vietnam. In late April, the company reported 95% efficacy in preventing severe Covid-19 in trials in Vietnam, and 55% efficacy in preventing symptomatic illness.

We have vaccines that continue to be very effective against serious disease and stopping people from ending up in hospital on ventilators and dying, says Adam Finn, immunologist at the University of Bristol, UK. But they arent very good at preventing people from getting infected. Meanwhile, Moderna and Pfizer and other vaccine companies have developed omicron-specific boosters, but it remains to be seen if these will be effective or necessary. Finn says current vaccines are tuned to the wrong virus, but you could rush to make a vaccine based on the latest variant, and by the time youve manufactured it, it is no longer the relevant variant. It might be that vaccines covering multiple variants will eventually be rolled out.

Immunologists view mixing of vaccines favourably, with the European Medicines Agency noting that combining mRNA and viral vector vaccines produces good levels of antibodies and a higher T-cell response. A booster with another platform will get a better response, says Mills.

Kings Colleges Penny Ward agrees: If we want to prevent symptomatic disease, then we will have to give boosters very frequently, six-monthly or perhaps even three-monthly. She views vaccines at a more efficient way to manage the disease than relying on more expensive antivirals.

Nonetheless, there is some opposition to the idea of continuing to boost significant numbers of people. This is not a tenable path, says Steve Brozak, biotech analyst. The speed of omicron was too fast. We can develop a prototype vaccine, but by the time you actually manufacture it, youre probably three quarters through the infection peak. Even in most wealthy countries, it will not be feasible to continue vaccinating the entire population at regular intervals. Instead of dealing with the virus, deal with the damage it does, Brozak suggests, for example using the cheap steroid, dexamethasone, which can reduce mortality in the severely ill. There are multiple efforts to dampen inflammation in severe Covid-19 with novel drugs.

Paul Offit, a vaccinologist at Childrens Hospital of Philadelphia, US, believes that boosters for young adults are not risk free and that vaccines were never meant to protect against infections or mild illnesses. Offit says that two or three doses of vaccine should suffice for most people. Immunisation can protect against severe disease for a long time, he says. He is critical of vaccine companies alluding to yearly vaccines, since theres no evidence for that yet.

The eventual fate of the Sars-CoV-2 virus remains uncertain. There is a strong suspicion that it will follow a path towards becoming a common cold coronavirus, although how long it would take to reach this destination is unknown. It might become a regular human endemic coronavirus over the next eight to ten years, says Penny Ward, and I think omicron is going to carry us from pandemic to endemic, but we dont know how much pathogenicity an endemic Sars-CoV-2 will carry with it.

Regular boosters of vulnerable groups may be needed for years to come to protect against severe disease, with Covid-19 sticking around to cause cold symptoms amongst healthy adults and severe illness among vulnerable people. Treatments for vulnerable patients will continue to be needed, especially in countries where vaccination and/or infection rates have been relatively low.

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Availability of COVID-19 vaccinations has been an issue for many regions of the world effected by the pandemic.1 Barriers to access and concerns over the vaccination continue to enable the development of viral mutations, whereas overall rates of vaccination have continued to stall.1 The need for safe and effective treatment against the various strains of COVID-19 increase, and investigators continue to assess various pharmacologic options. Antivirals and immunologic therapies that had shown efficacy in trials have continued to diminish in efficacy as mutations emerge.2 Other pharmacologic options studied have failed to show any clinical benefit for patients.3 Finding medications that have clinical efficacy continues to be of the highest importance.

Reis and colleagues evaluated the clinical efficacy of fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) and a -1 receptor agonist, at reducing the progression of COVID-19 to hospitalization.4,5 The appeal of medications in these classes include the widespread availability and affordability of these agents, alongside the well-documented safety profile.4 It is hypothesized that fluvoxamine could prove efficacious because of its anti-inflammatory and possible antiviral effects.4,5 A smaller, randomized, placebo-controlled trial found that higher-dosed fluvoxamine reduced hospitalizations and requirements in supplemental oxygen among mildly symptomatic, outpatient adults.6

The TOGETHER trial (NCT04727424) evaluated several repurposed pharmacologic therapies against COVID-19 in a multiarm, 1-to-1, placebo-controlled, double-blinded, randomized clinical trial among 11 sites in Brazil. Patients met criteria for inclusion if they were older than 18 years of age, had a positive SARS-CoV-2 diagnostic test at screening or within the previous 7 days, and had presented to an outpatient care clinic for COVID-19 symptoms, beginning within the previous 7 days. Patients were required to be unvaccinated and have a high-risk condition, including diabetes, hypertension requiring medication, cardiovascular disease, certain respiratory conditions (including asthma and smoking), a body mass index greater than 30 kg/m2, stage 4 or 5 chronic kidney disease, immunosuppression, or current or recent cancer. Patients were excluded if they required hospitalization for COVID-19, had an illness caused by other viral pathogens, had an inability to use SSRIs, or had dyspnea attributed to another acute or chronic lung disease, such as decompensated chronic obstructive pulmonary disease.4

Patients were randomly assigned to start fluvoxamine 100 mg twice a day for 10 days or matching placebo, along with standard-of-care therapies for symptom management in both arms. The primary outcome of interest was a composite end point of medical admission to a hospital setting for COVID-19, defined as an observation period lasting 6 or more hours in the emergency department or any referral for hospitalization within 28 days of randomization. Secondary end points of interest included associated times of disease progression or resolution, safety and tolerability of the trial medication, and clinical monitoring of disease severity.4

A total of 1497 participants were recruited and randomized to fluvoxamine (n = 741) or placebo (n = 756). Patients were randomized, on average, at 3.8 days of symptoms (standard deviation, 1.87). The studys intention-to-treat analysis found a significant reduction in the primary composite end point, attributed to the need for retention in the emergency setting for at least 6 hours (Table). The calculated number needed to treat (NNT) was 20 patients. All other secondary end points were unchanged compared with placebo. Rates of treatment-emergent adverse events did not differ significantly between fluvoxamine and placebo.4

The authors concluded that fluvoxamine may have a place in therapy for the management of outpatient, unvaccinated adults with COVID-19 infection to reduce the progression to hospitalization.4 The authors also call on subsequent research to establish whether these effects are a SSRI-class effect or related to fluvoxamine alone.4 Although fluvoxamine shows some statistical significance in reducing hospital setting visits, it appears this clinical benefit is limited to unvaccinated patients requiring extended stays in the emergency department, not those admitted to the hospital. Rates of hospitalization and death did not differ in the intention-to-treat population, although there was a statistical decrease in death in the per-protocol population.4 Some retrospective reviews have found reduction in mortality, but the benefit appears modest in this analysis.7 A recent commentary on outpatient therapeutics estimated that at a 5% risk of hospitalization, fluvoxamine had the lowest NNT at 80 patients and lowest total drug cost of $1122.8 There are also differences in the prescribing patterns of antidepressants in different parts of the world that would influence the generalizability of this trial.9,10 SSRIs continue to show promise for partial management of COVID-19, and ongoing clinical trials will help identify its place in therapy.11

References

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Pharmacotherapy Options for COVID-19: Does Fluvoxamine Have a Place in Therapy? - Contagionlive.com

1. COVID vaccine kids under 5: What to know about Pfizer, Moderna doses  USA TODAY
2. Pfizer COVID-19 vaccine: when could little kids get the vaccine?  NPR
3. Covid-19 roundup: Pfizer-BioNTech's Covid-19 vaccine is effective in young children  The Daily Briefing
4. Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose  Pfizer
5. Under-five COVID-19 vaccines near finish line  The Verge
6. View Full Coverage on Google News

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COVID vaccine kids under 5: What to know about Pfizer, Moderna doses - USA TODAY