Category: Covid-19 Vaccine

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mpox and COVID vaccines safe to get at same time: NACI – CTV News

May 25, 2024

The National Advisory Committee on Immunization says the mpox vaccine can be given at the same time as an mRNA COVID-19 vaccine, reversing its previous recommendation to wait at least four weeks due to safety concerns.

It said Friday that data is now available to show there is no increased risk of myocarditis or anaphylaxis for people who are given Imvamune, the vaccine for mpox, when they are also vaccinated against COVID-19.

The recommendation also says that Imvamune can be given at the same time as any other live or non-live vaccines.

The committee recommended the mpox vaccine two years ago after outbreaks in several countries, mostly among men who have sex with men as well as sex workers.

The first case in this country was reported to the Public Health Agency of Canada in May 2022, and the committee says there were 1,541 cases up to the end of last year.

Ontario had 737 cases, Quebec reported 531 cases and British Columbia had 213, the committee said.

Symptoms of the disease include a rash, fever, body aches, back pain and swollen lymph glands that appear within seven to 21 days after exposure.

Two doses of Imvamune are given at least 28 days apart to protect against the disease or as soon as possible after exposure to the virus to prevent illness or severe outcomes.

Those considered at highest risk of mpox include men who have sex with men and meet at least one of these criteria: they have more than one partner, are in a relationship where at least one of the partners has other sexual partners or they have had a confirmed sexually transmitted infection in the last year.

The committee says sex workers, regardless of gender or sexual orientation, are also at risk of infection, as are people who have had sexual contact in sex venues or work or volunteer there.

It says that while cases of mpox have declined significantly since the fall of 2022, the disease remains an important public health concern.

A spokeswoman with Toronto Public Health says the city has had 36 lab-confirmed cases so far this year compared to 27 cases for all of last year.

Toronto Public Health says the mpox vaccine will be offered by appointment at Metro Hall on June 1 and June 8 as part of Pride month awareness efforts that will also involve community organizations.

This report by The Canadian Press was first published May 24, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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mpox and COVID vaccines safe to get at same time: NACI - CTV News

Moderna, Novavax Hope for Early Launch of Covid-19 Vaccine This Year – Barron’s

May 21, 2024

U.S. vaccine makers say that the Food and Drug Administrations delay in designing this falls Covid-19 vaccines shouldnt push back the rollout of the shots, amid rapid shifts in the genetic makeup of the virus.

Vaccine makers Moderna and Novavax are hoping for an August rollout this year, earlier than last years late September debut of updated shots. Moderna CEO Stphane Bancel recently told Barrons that launching the shots in August instead of September could add three million doses to the market.

Sales of Pfizer , Moderna, and Novavax s shots fell far below expectations last year, setting off steep stock slides for all three of the companies. A better showing in the fall of 2024 could boost all three of the drugmakers.

The programs ran into a hiccup earlier this month, though, when the FDA delayed a May 16 meeting of its outside advisors to decide which strain of the virus the updated shots should address. As with the annual flu shots, Covid-19 shots are now tweaked each year to target the version of the virus currently circulating.

The virus that causes Covid-19 is a slippery target, and in recent weeks it has begun to change again. The FDA now plans to hold its strain selection meeting on June 5, a date thats still earlier than last years meeting, which was held June 15. In comments to Barrons on Monday, vaccine manufacturers seemed unfazed by the delay.

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A Moderna spokesperson said an August launch is still feasible, regardless of which strain the FDAs advisors choose. A Novavax spokesperson said that the later meeting date will not affect Novavaxs ability to deliver a Covid-19 vaccine this fall. A Pfizer spokesperson said that the company is aware of the date change, and that it is focused on working with the FDA.

The FDA, in a social media post on May 7, said it was delaying the meeting to allow more time to collect data to inform the committees recommendation. The postponement appeared to reflect the rapid changes in the makeup of the variant landscape in the U.S.

The strain that dominated in the U.S. since January of this year, known as JN.1, has begun to lose ground in recent weeks. The Centers for Disease Control and Prevention estimates that in the two-week period ending May 11, JN.1s prevalence had fallen to just 15%, as it has been surpassed by a number of its descendants. Chief among those descendants is the strain known as KP.2, which the CDC expects to have risen to 28.2% in the period ending May 11, quickly rising from just 1.4% in mid-March.

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The new variants replacing JN.1, including KP.2, share a handful of mutations scientists are calling FLiRT, which seem to give them an advantage over JN.1. CDC wastewater tracking shows that viral activity level for Covid-19 is currently minimal in the U.S.

Other global regulatory authorities have already made their decisions on which Covid strain to target. The World Health Organization said in late April said its advisory group recommended that new Covid-19 vaccines target JN.1. The European Medicines Agency made the same recommendation.

In an interview with Barrons in early May, Modernas Bancel said that his company had already begun manufacturing components for a shot targeting JN.1, but that the company was also preparing to make shots targeting one of the JN.1 descendants if necessary. We want to be a partner of the FDA from a public health standpoint, he said. They decide which strain goes into a vaccine and we will execute.

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Novavax, for its part, said at an earnings presentation May 10 that its also manufacturing a JN.1 vaccine, and that tests in non-human primates show that it induces an immune response against both JN.1 and the JN.1 descendant strains.

We have data which demonstrates good cross-reactivity between our JN.1 vaccine and KP.2, which is a JN.1 variant, the Novavax spokesperson said Monday. These data provide us confidence our vaccine has utility against the currently circulating strains.

Pfizer has not discussed its manufacturing plans for the fall Covid-19 shot.

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The question looming over the companies is how large the Covid-19 vaccine market will be this year, and whether an earlier launch will help with uptake. If the FDA and CDC can pull August off, I think the market should grow this year versus last year, Bancel told Barrons in early May.

Moderna, which so far is a pure play on Covid-19, saw its vaccine revenue fall 64% last year, to $6.7 billion, as demand for the vaccines evaporated.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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Moderna, Novavax Hope for Early Launch of Covid-19 Vaccine This Year - Barron's

Clotting due to Covid is perhaps 100 times more than clotting caused by a vaccine: Soumya Swaminathan at Idea Exchange – The Indian Express

May 21, 2024

As former chief scientist of WHO, Dr Soumya Swaminathan was the public face of science and research during the pandemic, demystifying COVID-19. Now, as chairperson of the MS Swaminathan Research Foundation, she is closely working on the impact of climate change on every aspect of our lives, particularly health. Her biography, At The Wheel of Research, documents her journey to make science the pillar of our public health. She speaks at the Idea Exchange session, moderated by Rinku Ghosh, Senior Associate Editor:

Rinku Ghosh: There is collective anxiety over the safety of Covid vaccines, what with AstraZenecas submission in court that in rare cases, its vaccine resulted in blood clotting. Considering that the same vaccine was used as Covishield in India, what kind of risks are we looking at?

Im very worried that this is going to have a negative impact on people, their beliefs and confidence in vaccines. When a vaccine is developed, it is tested several times over for its efficacy and safety. If a vaccine or drug is new, regulatory agencies conduct a post-marketing surveillance or a phase IV study. This is to capture rare side effects which might have been missed in clinical trials. For example, clinical trials for Covid vaccines had 30,000 to 40,000 participants. But when you give it to millions of people, then there may be rare things which you can pick up. This is why pharmacovigilance or post-marketing surveillance is important. Vaccines began to be administered by December 2020 as Pfizer, Moderna and AstraZeneca were approved in different countries. By March 2021, we had already heard about these thrombotic events, or Thrombotic Thrombocytopenic Purpura (TTP). At WHO, we were looking very closely at the data, which was coming out of high-income countries with good pharmacovigilance systems. These very rare side effects were mentioned in different reports from different countries, maybe somewhere in the range of four to eight per million vaccines. Every regulatory agency, including the WHO, looked at the safety profile again, assessed the risk-benefit ratio and concluded that the benefits far outweighed the risks. If you vaccinated a million individuals, the number of lives that you would save because of Covid was much more than these side effects. That has remained the same. So there has been no major change in our knowledge about this side effect since.

Second, Covid itself damages the lungs, the cardiovascular, brain and nervous systems and triggers clotting. All of us, who have suffered from Covid, now have a higher risk, may be by two to three times, of suffering health conditions related to these systems than ever before. If you have already had other risks say diabetes or hypertension then Covid is an add-on risk. The clotting due to Covid is many times, perhaps even a hundred times, more than the clotting due to the vaccine.

The third aspect is that the case revolves around the compensation thats being claimed by people who have had these severe side effects. At WHO, when we set up COVAX (COVID-19 Vaccines Global Access), we had already thought about setting up a no-fault compensation system globally. We took an insurance policy for hundreds of millions of people worldwide in low and middle-income countries, who would be receiving different vaccines. Till the time I was at WHO, there had been no claims. Im not sure if there has been any claim in the past year.

Besides, these side effects occur within a few weeks of taking the vaccine. So people whove taken the vaccine in 2021 or 2022 need not worry today about a clotting disorder. They will not get it because of the vaccine. They could get it because of Covid or an underlying condition that got exacerbated.

Rinku Ghosh: Is communicating science to the masses a big challenge because we lack scientific temperament?

Vaccine hesitancy or anti-science is not directly linked with the level of education. Countries with high vaccine hesitancy generally have high levels of education western Europe and US. Comparatively India has very small pockets of vaccine hesitancy but those were overcome by officials talking to the communities and so on.

Science is about doing experiments repeatedly because the truth could change when somebody finds something contradictory. Thats why theres a need for constant scrutiny. Usually, its a collective effort scientists around the world working in a particular discipline will have their own arguments. But during Covid, all of this was playing out in the public domain. So the layman saw scientists arguing and disagreeing, which is a normal scientific practice, but thought they couldnt make up their mind and deduced something was wrong. The anti-vax and anti-science groups took advantage of this gap in understanding. This is the first pandemic that weve had in the social media age. There will be more infodemics and we have to teach our children to sift facts. As public health people, we need to give, not hide information.

Nobody can deny that any drug or vaccine could have side effects. Even the polio vaccine has had side effects but that hasnt stopped the polio eradication programme. As scientists, we have to communicate in a way that makes information more acceptable. We have to be willing to constantly answer the same questions. Scientists cannot be patronising.

Rinku Ghosh: What are the big takeaways of COVID-19 and have we internalised them enough?

I can tell you the lessons from my perspective. How many governments and people have internalised them and are acting on them is a good question. We can see the push and pull in the negotiations of a global pandemic treaty to strengthen pandemic prevention, preparedness and response. This is a once-in-a-lifetime opportunity to actually put down on paper the lessons weve learnt and what needs to be done in the future.

First, a pandemic is a global issue and needs a global effort, solidarity and cooperation on surveillance, sharing data and R&D. Second is the issue of financing for which the World Bank has set up a fund. About $ 2 billion has come in as contribution and the bank has already finished one round of grants. We have to invest in science, be it to tackle climate change or for pathogen X. The third is investing in public health. Countries which had focussed more on public health infrastructure and primary healthcare actually did much better in terms of lowering deaths than first world countries. The US is a good example where the Centers for Disease Control and Prevention (CDC) public health budget had been cut year after year. So it couldnt do very simple things like contact tracing or scaling up surveillance. In contrast, poorer countries in Africa with a strong cadre of community health workers were able to do much better. Thailand is a prime example of a Southeast Asian country with excellent primary health care services. It was the first country outside China to locate the virus, put in place containment measures and use technology like South Korea did to test almost its entire population. The fourth is countering misinformation and the fifth is strengthening frontline workers. We need to pick up outbreaks quickly and you need an empowered team at the district level that immediately goes to the hotspot, investigates, reports, collects the data and acts on it. Decentralisation of data-based decision-making is the key.

Amitabh Sinha: How did the pandemic go away, what explains the negligible numbers now?

In a majority of countries, 60-70 per cent of the population has been vaccinated. Besides, people acquired immunity through natural infection. So a large part of the world today has cell-mediated as well as antibody-based immunity. And therefore, the virus is no longer able to extract the damage that it did in the early part. But the virus is still mutating and spreading. Were still getting infected but were not falling sick because our cell immunity kicks in and protects us. May be after four or five years that immunity will wane and we will all need boosters. Or a small infection may actually be boosting our immunity. We need regular studies on our levels of immunity.

Amitabh Sinha: Although we experienced the worst pandemic, none of the political parties has mentioned healthcare in manifestoes. Your take?

WHO Director-General Dr Tedros Ghebreyesus had predicted that we would go through this cycle of panic and neglect. We would panic in the middle of something terrible and ease away when we got a little comfortable. Im afraid thats happening all over the world. Other priorities have come up now, be it conflicts, trade wars, economic issues. There is no focus on health. I was happy that this time, during the World Bank-IMF Spring Meetings, the bank president, Ajay Banga, talked about a liveable planet, a sustainable lifestyle, health and nutrition. I think from the perspective of politicians, it is more rewarding to invest in a facility, which is very visible, because you can get credit from the local population.

Preventive healthcare is completely invisible. Its about making the right policies, laws and implementing them, dealing with lobbies and doing hard work behind the scenes. We have to implement the Rules on the Clinical Establishment Act. Thats why private hospitals continue to exploit the patient. And out-of-pocket expenditure in India though it has come down from 60 per cent to 45 per cent is still extremely high. I will again quote the example of Thailand, where the government actually invested in an organisation for health promotion and disease prevention. It is funded by taxes on tobacco, alcohol, sugar and unhealthy items.

Harish Damodaran: The remit of public health has traditionally been confined to communicable diseases like TB, malaria and viral infection. Now we are seeing lifestyle or non-communicable diseases like diabetes and cardiovascular conditions affecting the poor and lower middle-classes alike. Can we bring these under the public health umbrella?

Yes, public health is not just about communicable diseases. The WHOs SDG (Sustainable Development Goal) target 3.4 aims to reduce by one third premature mortality from non-communicable diseases through prevention and treatment by 2030. These are increasing rapidly in developing countries because of unhealthy diets and air pollution. The National Institute of Nutrition (NIN) data has shown that only a small fraction of the population is actually consuming a healthy diet. Some of it can be attributed to behavioural change as a recent household expenditure survey showed that 10 per cent of household expenditure, both in urban and rural areas, is now being spent on processed and ready-to-eat foods. Thats huge. May be, it has to do with convenience but it has also got to do with believing misleading advertisements that tell you these are healthy when actually they are not. A lot of public education drives have to be done on nutrition. A lot of policy and regulatory work needs to be done. We need to focus on agriculture and ensure we produce more nutritious food rather than focus on just rice and wheat. Dietary diversity has to improve. Big changes cannot be done without government intervention, certainly with regard to air quality and pollution.

My interest today is in looking at these determinants of health. Covid taught me to look upstream. We need an inter-sectoral and a holistic view of health, not a narrow one. Its a joke now that the Ministry of Health should perhaps be called the Ministry of Sickness and Disease, because its current focus is on managing a sick population. But the Ministry of Health also needs to be a steward and an advocate for good health across other ministries.

Rinku Ghosh: Recently, there was a row on added sugars in baby food and contaminants in spices. What would you say are the challenges of regulating food in India?

The primary focus of regulators in India has to be on public health and safety. For example, ban advertisements which have misleading information. Make sure that there is front of pack labelling on food, which is a simple traffic light system and has been adopted by many countries. As soon as you pick up a packet and see a red star on it, youre alerted that the package has been classified as unhealthy because it has high fat, sugar and salt. You dont even have to be literate to understand the potential dangers. Studies have shown how such labelling has helped in significantly reducing serious health outcomes like heart attacks. Strict labelling also compels the food industry into making healthier products.

As for contamination, lead poisoning is a huge public health risk in India. One of the sources is adulterated turmeric, which contains lead chromate to give it a bright yellow colour. A recent study across 10 cities showed that the average lead levels in children were far higher than the WHO cut-off. There is lead in our environment, coming from recycling batteries and paint. This is affecting the cognitive development of children. The Economist, in fact, had an article saying that if you get rid of lead, then your IQ levels improve.

Regulation and advertising are going to be important in dealing with the private sector. This is why we talk about commercial determinants of health, which are now as important as the social and environmental ones.

Anuradha Mascarenhas: How prepared are we for dengue outbreaks today? What about tuberculosis?

Dengue is the fastest-growing infection globally as the vector has adapted itself extremely well to living in cities. Genetic manipulation with Wolbachia bacteria can manipulate mosquito populations and reduce disease transmission. This has been tried in some countries. You have to breed and release a lot of mosquitoes with the Wolbachia to control dengue. A small place like Singapore probably can do it but it may be very difficult to do it across India. May be some cities could.

Were very close to eliminating diseases like filariasis and kalazar. As regards TB, the national prevalence survey indicates wide variations between states. The biggest risk factor for TB is under-nutrition with almost 50 per cent of cases being attributed to it. We have to think out of the box, use more technology and data-driven approaches. Statewise approaches will be different. In terms of financial resources, its going to require a multi-disciplinary approach.

Ankita Upadhyay: Are we doing enough to tackle air pollution, which comes at an enormous health cost?

In large parts of the country, the AQI (air quality index) is way above the WHO cut-off and even way above the Indian cut-off for PM 2.5, which is 40 g/m3. The more we learn about the health effects of air pollution, the more frightening it is. Setting up inflammatory cascades, pollution is impacting our brain, triggering early dementia. Its impacting the heart and lungs. Data shows that women exposed to pollution, particularly in the first and third trimester, have premature babies.

We do not need more data, we now need multi-sectoral action. By moving to clean energy, we can achieve net zero goals while reducing air pollution. We need to reduce the number of vehicles on the road and use public transport, cycle or walk. The Chief Technology Officer of the Transport for London told me that obesity rates in the city are much lower than those in other districts because people use public transport. In London, people are incentivised not to own cars. So if you want an apartment in the heart of London, they now have what are called ultra-low emission zones, which means you cannot own a car. You have to make a commitment to public transport, then the government has to provide it. It works both ways. In India, were still incentivising cars. We want three car parks with each apartment. In Geneva, I didnt have a car. I had a bicycle, I used to walk, take the train or bus.

Rinku Ghosh: Are you playing the violin and which is your favourite Beatles song?

No, I am not playing and have to restart practice. I listen to Hindustani music, old songs and jazz. I am a hiker and trekker and recently visited Kashmir. And my favourite Beatles song is probably Michelle.

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Clotting due to Covid is perhaps 100 times more than clotting caused by a vaccine: Soumya Swaminathan at Idea Exchange - The Indian Express

Here’s Yet Another Reason to Stay on Top of Your COVID Vaccine Boosters – ScienceAlert

May 21, 2024

If the effects don't fade too rapidly, new data suggests regular COVID-19 vaccinations could strengthen our immune systems against future variants and even related viruses. This is on top of the proven protection they already provide against current infections.

With thousands of people still being hospitalized each day, more and more of us battling long COVID, and new variants continuing to rapidly emerge, this is hopeful news.

"These data suggest that if these cross-reactive antibodies do not rapidly wane we would need to follow their levels over time to know for certain they may confer some or even substantial protection against a pandemic caused by a related coronavirus," explains Washington University immunologist Michael Diamond.

Other vaccinations, such as those for the flu, are not necessarily made more effective by booster shots. Initial vaccinations prompt our immune system to create antibodies to recognize and fight an invasive virus. The details of the antibody are carried by memory immune cells, which help keep watch for and sound the alarm if the virus reappears, quickly producing more of the specific antibodies to defend against it.

When it comes to the flu, these cells are then so good at their jobs, they overwhelm our attempts to introduce updated antibodies through subsequent vaccinations. This is problematic as it leaves little chance for our bodies to store the more updated antibodies' details in memory B cells, weakening our response to future viral variants.

There was some concern this would occur with COVID-19 vaccines, too. So, using a mouse model and human volunteers who had contracted SARS-CoV-2, Washington University immunologist Chieh-Yu Liang and colleagues examined the memory B cell antibodies after different combinations of vaccines.

Incredibly, the researchers found that across doses, the response of the immune system to variants of the virus grows stronger, which is a sign of positive imprinting. In both humans and mice, rather than seeing antibodies specific to any one variant, the researchers found the majority of the antibodies reacted to both tested COVID-19 strains the original and omicron.

Further tests in mice revealed not only could the antibody response deal with a panel of different SARS-CoV-2 strains, but it could also help subdue SARS-CoV-1 as well, which derives from the 2002 to 2003 epidemic.

"In principle, imprinting can be positive, negative or neutral," explains Diamond. "In this case, we see strong imprinting that is positive, because it's coupled to the development of cross-reactive neutralizing antibodies with remarkable breadth of activity."

Questions about the longevity of the antibodies in our system still remain, as the researchers only tested the immune response one month after the latest booster. What's more, the study only focused on mRNA vaccines, so the results may not be the same in other types of vaccines. Additionally, human studies were limited, so further work is required to see if these results hold true more broadly, particularly in children.

But since uncertainty around COVID-19 vaccines early on in the pandemic, these shots have saved at least tens of millions of lives. What's more, massive studies have decisively demonstrated that the severe risks from the vaccines are extremely rare, especially in comparison to the ongoing and accumulative risks from contracting the virus.

The new study suggests we now have even more reason to keep up those regular boosters.

"At the start of the COVID-19 pandemic, the world population was immunologically nave, which is part of the reason the virus was able to spread so fast and do so much damage," says Diamond. "We do not know for certain whether getting an updated COVID-19 vaccine every year would protect people against emerging coronaviruses, but it's plausible."

This research was published in Nature.

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Here's Yet Another Reason to Stay on Top of Your COVID Vaccine Boosters - ScienceAlert

Risk of clotting from COVID-19 could be 100 times more than from vaccines, says former WHO chief scientist – The Financial Express

May 21, 2024

Pharmaceutical giant AstraZeneca recently admitted that its COVID-19 vaccine can cause a rare side effect of blood clotting. This acknowledgment came amidst legal action against the company that alleged severe harm and deaths linked to the vaccine, resulting in a rising concern among the people.

Dr Soumya Swaminathan former Chief Scientist of the World Health Organization (WHO), in an interaction with The Indian Express, gave her insights on several issues concerning COVID-19 vaccines. Among this, she also touched upon the subject of clotting due to the vaccines.

The clotting due to Covid is many times, perhaps even a hundred times, more than the clotting due to the vaccine, she said.

Addressing the public anxiety regarding the safety of COVID-19 vaccines, she expressed concern that this could undermine public confidence in vaccines. She emphasized the rigorous testing vaccines undergo for efficacy and safety. She highlighted that regulatory agencies conduct post-marketing surveillance or phase IV studies to detect rare side effects that could have been missed in clinical trials with smaller participant numbers.

She also elaborated that clinical trials for COVID-19 vaccines involved 30,000 to 40,000 participants, but rare side effects, like Thrombotic Thrombocytopenic Purpura (TTP), emerged when millions were vaccinated.

Every regulatory agency, including the WHO, looked at the safety profile again, assessed the risk-benefit ratio, and concluded that the benefits far outweighed the risks, she said

The rare side effects associated with COVID-19 vaccines like Covishield and Covaxin include pericarditis, myocarditis, and blood clotting.

Earlier this month, parents of 8 victims from Kerala, Mumbai, Coimbatore, Hyderabad, Bengaluru, and Kapurthala alleged that the deaths of their children were a result of the side effects of the Covishield vaccine. They intended to sue Punes Serum Institute of India and government officials responsible for the COVID-19 vaccine rollout.

Dr. Swaminathan discussed the difficulty of communicating scientific information to the public. She noted that vaccine hesitancy is not linked to education levels, as it is higher in well-educated regions like Western Europe and the US compared to India. Misunderstandings about scientists debates during the pandemic led to distrust, worsened by social media. She expressed that better public health communication and education are needed to counter misinformation.

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Risk of clotting from COVID-19 could be 100 times more than from vaccines, says former WHO chief scientist - The Financial Express

Test kits fly off the shelves as Covid-19 infection cases spike in Singapore – The Straits Times

May 21, 2024

SINGAPORE Covid-19 antigen rapid test (ART) kits flew off the shelves at many pharmacies over the weekend after news broke that Singapore is facing a new wave.

Cases of Covid-19 have been rising in the last two weeks, a result of the Covid-19 sub-variants, which scientists have nicknamed FLiRT, drawing from the letters in the names of their mutations.

Globally, variant JN.1 and its sub-lineages, including KP.1 and KP.2, remain the predominant Covid-19 variants. The combined proportion of KP.1 and KP.2 currently accounts for more than two-thirds of the cases in Singapore.

As of May 3, the World Health Organisation has classified KP.2 as a variant under monitoring.

There are currently no indications, globally or locally, that KP.1 and KP.2 are more transmissible or cause more severe disease than other circulating variants.

Watsons has seen demand for Covid-19 test kits surge by more than 150 per cent in the past week, its Singapore managing director Irene Lausaid.

Our stores are well-stocked, and we have scheduled replenishments. We continuously seek collaborations with partners to promptly address any further increases in demand.

A Guardian spokeswoman said the chain has seen an increase in demand for Covid-19-related items, such as masks, test kits and cough and cold medicine, in line with the recent wave.

Despite this rise, there have been no instances of insufficient stock over the past two weeks. Guardian is proactively managing our inventory and working very closely with our suppliers to ensure that we maintain sufficient stock levels to meet our customers needs during this period, she said.

Heeding the Governments call for people to get an additional Covid-19 vaccine dose was Mr Senthil Nathan, 47, who was at the Sengkang joint testing and vaccination centre (JTVC) getting his fifth shot on May 20.

Mr Senthil, who works in the information technology industry, told The Straits Times he underwent a heart transplant more than 10 years ago and is on immunosuppressant drugs and has low immunity.

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Test kits fly off the shelves as Covid-19 infection cases spike in Singapore - The Straits Times

SMH board to ponder adoption of controversial anti-vaccine stance – Sarasota Herald-Tribune

May 21, 2024

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SMH board to ponder adoption of controversial anti-vaccine stance - Sarasota Herald-Tribune

Antibody longevity and waning following COVID-19 vaccination in a 1-year longitudinal cohort in Bangladesh … – Nature.com

May 21, 2024

Study design, setting and study population

Participants of this cohort study were recruited from Sheikh Russel Gastroliver Institute & Hospital (SRGIH), a public sector health facility in Dhaka, Bangladesh when they visited the hospital to receive second dose of COVID-19 vaccines. Adults who received two doses of COVID-19 vaccines (OxfordAstraZeneca COVID19 vaccine or Covishield (viral vector-based vaccine), Pfizer-BioNTech (BNT162b2) (mRNA vaccine), Moderna (mRNA-1273) (mRNA vaccine) or Sinopharm (BBIBP-CorV) (inactivated whole virus vaccine)), were enrolled within 24weeks of receiving the second primary dose (visit 1) and followed-up at 4months (visit 2), 8months (visit 3) and 12months (visit 4). The inclusion criteria for participation were: (1) male or female adults (aged 18years and above), (2) able to understand and sign the informed consent form, (3) available and reachable by study staff for the entire period of the study; (4) agreeing to provide blood sample for the research study. The exclusion criteria were: (1) residence outside of Dhaka city; (2) suffering from long term severe illness such as cancer, chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD).

Enrolment of participant started in September 2021 and ended in July 2022. Bangladesh received different types of COVID-19 vaccines at different time points either through COVAX or direct procurement, therefore availability of vaccinated individuals with any particular type of COVID-19 vaccine varied by time. Therefore, enrolment of vaccine groups varied by months. The Covishield was the first COVID-19 vaccine that was rolled out in Bangladesh and thus our first enrolled vaccine group was AstraZeneca vaccine. Administration of booster dose started in December 2021 in limited hospitals amongolder peoples (>60years of age) and age limit was gradually descended towards younger population. The participants of the AstraZaneca vaccine group received booster dose after almost 89months.

A structured questionnaire was utilized to collect data from each study participant at enrollment (visit 1, 24weeks after administration of 2nd primary dose) and each follow-up visit, i.e. at 4months (visit 2), 8months (visit 3) and 12months (visit 4) post second dose (Fig.1). Collected data included socio-demographic information (age, sex, education, migration background, ethnicity, marital status, household structure, occupation, and income), influenza-or COVID-like symptoms or presence of confirmed COVID-19 cases currently and in the past 6-months; co-morbidities (e.g. diabetes, hypertension, stroke, heart diseases and asthma). The vaccination type and administration dates were recorded. Information on receipt of booster dose was also collected during the follow-up phase. Height and weight were collected using stadiometer (Seca 217, Hamburg, Germany) and digital weighing scale (Camry-EB9063, China), respectively. Venous blood was collected at each visit in Lithium-heparin coated tubes (S-Monovette Plasma, Sarstedt AG & Co. KG, Nmbrecht, Germany), plasma was separated upon centrifugation, aliquoted, and stored at -80C until use.

The concentration of S-specific antibodies was determined in plasma by Elecsys Anti-SARS-CoV-2 S immunoassay kit (Roche DiagnosticsGmbH, Mannheim). This assay allowed quantitative determination of high affinity antibodies, predominantly IgG, but also IgA and IgM directed to the SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in a double-antigen sandwich assay format on Cobas-e601 analyzer (Roche Diagnostics). According to the kit insert, the sensitivity of the Elecsys AntiSARSCoV2 S assay is 98.8%, clinical specificity is 99.98%, and the assay was found to have 92.3% positive agreement rate with a Vesicular Stomatitis Virus (VSV)-based pseudo-neutralization assay.

Nucleocapsid (N)-specific antibodies was determined in plasma by Elecsys Anti-SARS-CoV-2 immunoassay kit (Roche Diagnostics). The kit allows simultaneous detection of mature Nucleocapsid-specific IgM and IgG antibodies on an automated immunoassay analyzer (Cobas-e601, Roche Diagnostics). This is a qualitative assay that gives combined antibody titers of both IgM and IgG and does not differentiate between the two types. Based on the antibody cut-off index (COI), the serological response to SARS-CoV-2 is categorized as reactive (COI1.0, seropositive) and non-reactive (COI<1.0, seronegative). According to the kit insert, the Elecsys Anti-SARS-CoV-2 assay has 99.8% specificity and>99.5% sensitivity.

All participants vaccinated with viral vector-based vaccines (AstraZeneca) and mRNA vaccines (Pfizer and Moderna) were tested for N-antibodies to identify previous exposure to or infection with SARS-CoV-2. Participants immunized with Sinopharm vaccine (inactivated whole virus) were not tested for N antibodies as it is not possible to differentiate the N-antibodies induced by vaccination from those generated due to natural infection with SARS-CoV-2.

The study participants were defined as SARS-CoV-2 infected when tested positive by RT-PCR or showed COVID-like symptoms and concomitantly positive for N-antibodies. Individuals who did not exhibit COVID-like symptoms and were negative for N- antibodies or tested negative by RT-PCR were considered uninfected with SARS-CoV-2.

The authors affirm that all procedures involved in this research adhered to the ethical standards set by the pertinent national and institutional committees overseeing human experimentation, aligning with the Helsinki Declaration of 1975, revised in 2008. The study received approval from the institutional review board of icddr,b (PR-21069, dated 17 August 2021). Written informed consent was obtained from the participants.

The sample size was calculated based on the primary endpoint, i.e. to assess the persistence of SARS-CoV-2 S-specific antibody response following two primary doses of COVID-19 vaccines. A study by Shrotri M et al.12, demonstrated a decline of antibody titers by 19.7% from 0 to 21days to 2241days after administration of two doses of Pfizer vaccine. Based on this information, and considering statistical power of 80% and confidence interval of 95%, the estimated sample size was 64 per vaccine group. To reduce unknown bias due to different localities and socio demographic status, and unknown effects of COVID-19 vaccination, a design effect of 2 was added, which resulted in a sample size of 128. Considering 10% attrition rate, the final sample size was 140.8 (rounded to 141) per vaccine group and the total sample was 564. Despite rigorous efforts, we encountered difficulties in recruiting the target number of participants in the study. Within the duration of the study, administration of different COVID-19 vaccines was paused at different period. We were able to enroll only 452 participants, with the highest number in AstraZaneca vaccine group.

We showed basic demographic characteristics of the study participants, categorized by the respective vaccine types received (Pfizer, Moderna, AstraZeneca, and Sinopharm).

S-antibody data exhibited a right-skewed distribution in a histogram. To address this non-normal distribution, a natural log transformation was employed. To analyze the durability of S-antibody titers at different visits post-primary vaccination (primary endpoint), the participants across all vaccine groups were categorized into two groups: Group I consisted of individuals who remained uninfected with SARS-CoV-2 (defined above) and did not receive a 3rd dose of vaccine during the one-year study period. Group II included participants who got infected with SARS-CoV-2 (defined above), and did not receive a 3rd dose of vaccine during the study period. Furthermore, to assess the kinetics of S- antibody titers after the 3rd dose (secondary endpoint 1), the recipients were divided into 2 groups: Group III consisted of individuals who received the 3rd dose of vaccine between visit 2 and 3, and remained uninfected up to visit 4 (n=55); Group IV participants received the 3rd dose of vaccine between visits 2 and 3, but got infected with SARS-CoV-2 between visits 3 and 4 (n=12). Since the number of 3rd dose recipients was relatively small, the analysis in group III and IV was not stratified based on the type of COVID-19 vaccine received. Moreover, the AstraZeneca group was excluded from this analysis as this group received the 3rd dose between visit 3 and 4 (n=105), and could not be followed further after completion of 1-year follow-up to observe the durability of S-antibodies. To evaluate the mean differences in S-antibody titers between any two visits in each of the groups (groups I to IV), a multivariate regression model was employed. Repeated measure ANCOVA model was employed to examine the mean differences in S-antibody titers between multiple visits within a group. In order to determine the optimal model, age, sex, household income, occupation, body mass index (BMI), education, comorbidities, etc. were incorporated as covariates in the regression model. The effects of education and comorbidities was found minimal (<1%), thus, not included in the final regression model.

To assess the degree of protection from infection with SARS-CoV-2 (secondary endpoint 2) in mRNA and viral vector-based vaccine groups compared to inactivated vaccine as the reference group, Bayesian framework was adopted and Markov Chain Monte Carlo (MCMC) method was utilized to derive posterior distributions of model parameters. Furthermore, we applied model evaluation techniques and conducted sensitivity analyses to ensure the robustness of our results.

All statistical analyses were conducted using STATA (version 15) and Python (3.11), and GraphPad Prism was utilized for generating graphs. Significance was defined as a p-value of<0.05.

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Antibody longevity and waning following COVID-19 vaccination in a 1-year longitudinal cohort in Bangladesh ... - Nature.com

First Approved Self-amplifying COVID-19 Vaccine Publishes Positive Study Results – Precision Vaccinations

May 21, 2024

(Precision Vaccinations News)

CSL and Arcturus Therapeutics today announce the journal Nature Communicationshas published results from an integrated phase 1/2/3a/3b study evaluating the safety, immunogenicity, and efficacy of ARCT-154, a novel self-amplifying (sa-mRNA) COVID-19 vaccine.

ARCT-154 is the world's first approved sa-mRNA COVID-19 vaccine for use in Japan.

The joint study's results demonstrate that two 5 g doses of ARCT-154, sa-mRNA vaccine, were well-tolerated, immunogenic, and provided significant protection against multiple strains of COVID-19.

The efficacy of ARCT-154 against severe COVID-19 was 100%in healthy persons aged 18-59 and more than 90%in persons at risk of severe consequences of the disease due to co-morbidities or older age.

"The results published inNature Communicationsdemonstrate the efficacy and tolerability of ARCT-154 and add to a growing body of evidence that our sa-mRNA vaccine has the potential to provide significant protection against the pervasive virus, reinforcing our promise to protect public health," said Jon Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL, in a press release on May 20, 2024.

Unlike standard mRNA vaccines, sa-mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

CSL is a global biotechnology company with aportfolio of medicines and vaccines.

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First Approved Self-amplifying COVID-19 Vaccine Publishes Positive Study Results - Precision Vaccinations

Uptake of flu, whooping cough, and COVID-19 vaccines remains low among pregnant women – Medical Xpress

May 21, 2024

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A study conducted by researchers at the University of Warwick has unveiled crucial insights into the complex factors shaping vaccination decisions among pregnant women, particularly in the wake of the COVID-19 pandemic.

Pregnant women and their unborn babies face heightened risks of serious illness from infectious diseases such as Influenza (flu), Pertussis (whooping cough), and COVID-19. The research shows that despite the proven safety and efficacy of vaccinations during pregnancy, uptake remains alarmingly low, presenting a significant public health concern.

Despite the availability of free vaccinations for pregnant women in the U.K., of those who gave birth in England in October 2021, 29.4% had received two doses of the COVID-19 vaccine, compared to approximately 60.4% of the general population.

The study, titled "What factors influence the uptake of vaccinations amongst pregnant women following the Covid-19 pandemic: A qualitative study," published in Midwifery, interviewed pregnant women aged between 19 and 41 exploring their perceptions, experiences, and the factors influencing their decisions regarding vaccinations.

Dr. Jo Parsons from the University of Warwick who led the research said, "This research demonstrates the influence that the COVID-19 pandemic has had on pregnant women's views and uptake of recommended vaccinations and is further evident by the continuing decline in uptake since the pandemic.

"It is essential that pregnant women receive clear and consistent messaging, to allow them to make accurate and informed choices about vaccinating in pregnancy."

The findings are categorized into four main areas, each influencing pregnant women's vaccination decisions:

Commenting on the significance of the study, Dr. Jo Parsons said, "This research is vital to learn how pregnant women feel about accepting vaccinations following a pandemic, and how to address low uptake, to protect more pregnant women from largely preventable conditions. This research provides valuable insights and informs future interventions to be developed."

More information: Dr Jo Parsons et al, What factors influence the uptake of vaccinations amongst pregnant women following the Covid-19 pandemic: A qualitative study, Midwifery (2024). DOI: 10.1016/j.midw.2024.104021

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Uptake of flu, whooping cough, and COVID-19 vaccines remains low among pregnant women - Medical Xpress

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