‘Maybe the coronavirus was lower-hanging fruit’

‘Emerging mRNA technology proved excellent for COVID vaccines. BioNTech’s founders preview what that could mean for cancer and other mysteries...

‘The fact that mRNA technology had never delivered an authorized therapy before the coronavirus pandemic could tell us one of two things. Perhaps synthetic mRNA is like a miraculous key that humankind pulled out of our pockets in this pandemic, but it was so perfectly shaped for the coronavirus that we shouldn’t expect it to unlock other scientific mysteries any time soon.

‘Or perhaps mRNA is merely in the first chapter of a more extraordinary story. This month, BioNTech announced that it had initiated Phase 2 trials of personalized cancer vaccines for patients with colorectal cancer. It is working on other personalized cancer vaccines and exploring possible therapies for malaria using a version of the mRNA technology that had its breakout moment in 2020.’

Read here (The Atlantic, Oct 18, 2021)

Sinopharm vaccine for children: Some findings

‘Results from another study evaluating the Sinopharm SARS-CoV-2 vaccine in children were published on September 15 in The Lancet Infectious Diseases. The Phase 1/2 trial examined the safety and immunogenicity of the vaccine in a cohort of children aged 3-17 years, with participants broken into several age groups (3-5, 6-12, and 13-17 years) and dosing groups (0 [control], 2µg, 4µg, and 8µg). Three (3) doses of each vaccine dosage or placebo were administered 28 days apart. All adverse events were categorized as mild or moderate severity, but the article does not report on serious adverse events. The study concluded that children who received the vaccine had robust immune responses and similar levels of neutralizing antibodies to those observed in older vaccine recipients. The study recommended a 2-shot 4µg dose regimen for future Phase 3 trials. Additional data are being collected through a Phase 3 trial currently taking place in the UAE. 

Read here (The Lancet Infectious Disease, Sept 15, 2021)

India’s DNA Covid vaccine is a world first – more are coming

‘India has approved a new COVID-19 vaccine that uses circular strands of DNA to prime the immune system against the virus SARS-CoV-2. Researchers have welcomed news of the first DNA vaccine for people to receive approval anywhere in the world, and say many other DNA vaccines might soon be hot on its heels.

‘ZyCoV-D, which is administered into the skin without an injection, has been found to be 67% protective against symptomatic COVID-19 in clinical trials, and will probably start to be administered in India this month. Although the efficacy is not particularly high compared to that of many other COVID-19 vaccines, the fact that it is a DNA vaccine is significant, say researchers.

‘It is proof of the principle that DNA vaccines work and can help in controlling the pandemic, says Peter Richmond, a paediatric immunologist at the University of Western Australia in Perth. “This is a really important step forward in the fight to defeat COVID-19 globally, because it demonstrates that we have another class of vaccines that we can use.”

Read here (Nature, Sept 2, 2021)

Singapore SARS survivors yield hope for Covid super vaccine

‘Survivors who lived through the SARS crisis in Singapore nearly two decades ago may yield hope for the development of a super vaccine to combat potent Covid-19 variants and even other coronaviruses, new research shows.

‘Scientists from the city-state’s Duke-NUS Medical School and National Centre for Infectious Diseases (NCID) have found “highly potent functional antibodies” in people who had severe acute respiratory syndrome and were vaccinated with Pfizer-BioNTech’s shots for Covid-19.’

Read here (Free Malaysia Today, August 21, 2021)

Delta variant: Everything you need to know -- Tomas Pueyo

‘Delta is a deadly variant. It spreads like wildfire and kills efficiently. We need to be careful.

If you’re an individual

‘If you’re vaccinated, you’re mostly safe, especially with mRNA vaccines. Keep your guard up for now, avoid events that might become super-spreaders, but you don’t need to worry much more than that. If you’re not vaccinated though, this is a much more dangerous time than March 2020. The transmission rate is higher than it used to be, and if you catch Delta, you’re much more likely to die—or get Long COVID. You should be extra careful, only hang out with other vaccinated people, and avoid dangerous events.’

If you’re a community leader

‘If you’re in charge of a community, you have two goals:

1. ‘Vaccinate, vaccinate, vaccinate. The lives of your community depend on it. Any vaccine that works is better than none. If people are opting out, try to lure them in. Most are not anti-vaxxers, but rather they’re on the fence, or simply don’t see the benefit worth the cost. So change their calculation. Create lotteries. The Ohio one, among the first, probably didn’t work, but the cost is paltry compared to the cost of deaths and closing the economy this Fall.
2. ‘Keep Delta at bay as much as you can while vaccinations proceed. An elimination strategy will be best. Good border fences and test-trace-isolate programs are your best tools. Super-spreader events should still be avoided. Masks indoors and in crowds should be mandatory. Great ventilation is a must. 

‘However, if you have vaccinated everybody that wants to be vaccinated, and the rest simply doesn’t want to get vaccinated, then the calculation changes drastically. If your location values the freedom of its people to make the wrong decisions (as long as they don’t impact others), then you might consider opening up the economy. Delta will tear through those unvaccinated, but that’s their prerogative. Maybe the reality will hit better then.

‘But it really depends on each society. Opening up without full vaccination would infect some of those vaccinated, about 10% of them would get long COVID7, and about 0.3% of them would die8.

‘So here each society needs to decide. Say 40% don’t want to vaccinate. Is the freedom of 40% to not vaccinate worth the deaths and Long COVID of those vaccinated? Otherwise, are you willing to force people to vaccinate? Are you going to keep the country closed until there’s a booster vaccine? Will you be able to get your fences and test-trace-isolate programs to work?’

If you’re in charge of vaccine policy

‘An R0 of 8 is bad news for herd immunity. It puts its threshold at ~90% of people protected, which is impossible to reach if vaccines are only 65% protective of infection. Booster shots are necessary. Let’s accelerate their testing, approval, release, and deployment.

‘Also, support vaccine mix-and-match. In most countries, today, if you need a boost you are forced to take the same vaccine. But mixing types likely protects you better and is as safe as using the same type.’

If you’re in a developing country

‘We don’t pay enough attention to developing countries. Most of the science and media focuses where the money is, in developed economies. But Delta is very hard in developing countries, especially in dense urban areas where the poor are forced to work but live in close quarters with many others. India, Argentina, Tunisia, South Africa, and Indonesia are very sad examples of this. 

‘Unfortunately, there’s not many special tricks that poor countries can pull. They tend to have a younger population, which helps. The one thing they have going on for them is that they tend to be warmer and more humid, which helps against COVID. Also, thanks to a warmer weather, they can have more events outdoors. This is the one thing they can leverage: have as many of your gatherings outside, while you do everything you can to vaccinate your population, and delay as much as you can the arrival of Delta with strong fences. 

‘Let’s hope vaccine production keeps growing and people the world over can get vaccinated before the fall.’

Read here (Uncharted Waters, Aug 11, 2021)

Kati Kariko helped shield the world from the coronavirus

‘Collaborating with devoted colleagues, Dr. Kariko laid the groundwork for the mRNA vaccines turning the tide of the pandemic...

‘Now Katalin Kariko, 66, known to colleagues as Kati, has emerged as one of the heroes of Covid-19 vaccine development. Her work, with her close collaborator, Dr. Drew Weissman of the University of Pennsylvania, laid the foundation for the stunningly successful vaccines made by Pfizer-BioNTech and Moderna.

‘For her entire career, Dr. Kariko has focused on messenger RNA, or mRNA — the genetic script that carries DNA instructions to each cell’s protein-making machinery. She was convinced mRNA could be used to instruct cells to make their own medicines, including vaccines.

‘But for many years her career at the University of Pennsylvania was fragile. She migrated from lab to lab, relying on one senior scientist after another to take her in. She never made more than $60,000 a year.’

Read here (New York Times, Apr 7, 2021)

From the pandemic, a roadmap for lowering the costs of medicine

‘To speed Covid-19 treatments, federal officials adopted a new, nimbler regulatory posture. The change was long overdue...

‘In recent decades, for example, the FDA — scarred by episodes like the Vioxx debacle and buoyed by scientists’ increased understanding of the body — has pressed drug makers to demonstrate increasingly rigorous understanding of the mechanisms by which their medicines work. Yet, one might argue that these guidelines reflect either hubris or naivete: The vast majority of safe and effective drugs were approved despite uncertainty about their mechanisms of action. Even today, scientists do not completely understand how acetaminophen works, yet the world is a far healthier place for having this drug...

‘In some high-profile cases during the pandemic, the FDA leaned less on mechanistic proof of effectiveness and more on empirical indicators, such as patient survival rates. For instance, when objective data revealed that the steroid dexamethasone helped severely ill patients survive what might otherwise have been deadly coronavirus infections, the FDA was quick to support the drug’s use, despite scientists having only a speculative understanding of how the steroid works against the disease. To be sure, the FDA must continue to prioritize its mandate to protect patients and clinical trial volunteers. But the pandemic has shown that safety and speed need not be an either-or proposition.’

Read here (Undark, Mar 25, 2021)

The scene from Cuba: How it’s getting so much right on Covid-19

‘As the COVID-19 pandemic disproportionately harms underprivileged people globally, Cuba’s “people over profit” approach has been saving many lives — both on the island and abroad. From the onset, Cuba’s approach has been holistic and integrated.

‘Its response is among the most respected in the world. Widespread confidence in the Cuban government’s science-based policies, public service media messaging and volunteerism are key reasons as to why Cuba has been able to control the viral reproduction rate until mass vaccination begins.

‘The cash-strapped Caribbean island risked opening to holiday visitors at the end of 2020 and is currently managing higher COVID-19 caseloads than ever before. Its health experts are combining international clinical trials of its vaccine candidates with mass production. Cuba is the only Latin American country with the capacity to manufacture a vaccine domestically other than Brazil, which is not doing so. Cuba aims to protect its populace, then give away or sell its vaccines abroad.’

Read here (The Conversation, Mar 17, 2021)

Moderna begins study of Covid-19 vaccine in kids

‘Moderna Inc has begun dosing patients in a mid-to-late stage study of its COVID-19 vaccine, mRNA-1273, in children aged six months to less than 12 years, the company said on Tuesday (Mar 16). The study will assess the safety and effectiveness of two doses of mRNA-1273 given 28 days apart and intends to enrol about 6,750 children in the United States and Canada.’

Read here (Channel News Asia, Mar 16, 2021)

Coronavirus and the money behind vaccines

The FT explains how the vaccine market works – including the cost of a vaccine and the vaccine development process – and the impact of the Covid-19 pandemic. This short documentary features global experts including Bill Gates, the CEOs of Moderna and Gavi, and the lead scientist behind the Oxford/AstraZeneca vaccine. 

View here (Financial Times, Youtube, Mar 10, 2021)

India’s Covid vaccine rollout ‘rescued the world’: Top US scientist

‘Dr Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine (BCM) in Houston during a recent webinar said that the two mRNA vaccines may not impact the world's low- and middle-income countries, but India's vaccines, made in collaboration with universities across the world such as BCM and the Oxford University, have "rescued the world" and its contributions must not be underestimated.

‘During the webinar, "Covid-19: Vaccination and Potential Return to Normalcy - If and When", Dr Hotez, an internationally-recognised physician-scientist in neglected tropical diseases and vaccine development, said that the Covid-19 vaccine rollout is "India's gift'' to the world in combating the virus.

‘India's drugs regulator gave emergency use authorisation to Covishield, produced by Pune-based Serum Institute of India after securing licence from British pharma company AstraZeneca, and Covaxin, indigenously developed jointly by Hyderabad-based Bharat Biotech and Indian Council of Medical Research scientists.’

Read here (India Today, Mar 7, 2021)

Finding an ultimate vaccine to fight the mutating “emperor” virus

‘We are commenting on the shocking CNN website report (March 2), headlined “All our recent progress with COVID-19 could be wiped out by variants, CDC director says”. The first two paragraphs (below) are enough to sum up the CNN report: “The US is at risk of losing all its recent gains in the battle against COVID-19 as highly contagious variants take advantage of Americans getting lax with safety measures... “Please hear me clearly: At this level of cases with variants spreading, we stand to completely lose the hard-earned ground we have gained,” said Dr Rochelle Walensky, director of the US centers for Disease Control and Prevention (CDC).”...

‘With new variants, serious doubts are suggested by the CNN report on whether this “vaccine” [mRNA], the first in the global market, would work, even if safety factor is put aside. Nevertheless, there are safe and workable vaccines, using tried and tested technologies like using inactivated or attenuated virus from nature to stimulate the body to produce anti-body response. Even the adenovirus viral vector technology, tried and tested for Ebola, appears to be safer than mRNA.

‘There are also safe and good alternatives, like the anti-viral “broad spectrum” drug Ivermectin, which can destroy the new variants. In the meantime, it is vital that we improve our body immunity against COVID-19 by taking Vitamin C with zinc, Vitamin D, minerals and trace elements needed, explore proven traditional and complimentary medicines, and maintain established standard operating procedures (SOPs) of physical distancing, wearing surgical masks and personal hygiene in public places.’

Read here (Focus Malaysia, Mar 4, 2021)

As the world vies for vaccines, Cuba’s making its own

‘Cuba may be on the verge of a coronavirus vaccine breakthrough and not a moment too soon, as deaths and cases spike on the communist-run island.

‘Starting in March, two of the island's four homegrown vaccine candidates will begin their third and final trials, the Cuban government has announced. While other developing countries compete with richer nations for a limited supply of doses, Cuba has gambled everything on producing their own vaccines, as much an exercise in national pride as a response to a public health crisis.’

Read here (CNN, Mar 3, 2021)

To beat Covid, we may need a good shot in the nose

‘Intranasal vaccines might stop the spread of the coronavirus more effectively than needles in arms...

‘Although injected vaccines do reduce symptomatic COVID cases, and prevent a lot of severe illness, they may still allow for asymptomatic infection. A person might feel fine, but actually harbor the virus and be able to pass it on to others. The reason is that the coronavirus can temporarily take up residence in the mucosa—the moist, mucus-secreting surfaces of the nose and throat that serve as our first line of defense against inhaled viruses. Research with laboratory animals suggests that a coronavirus infection can linger in the nose even after it has been vanquished in the lungs. That means it might be possible to spread the coronavirus after vaccination.

‘Enter the intranasal vaccine, which abandons the needle and syringe for a spray container that looks more like a nasal decongestant. With a quick spritz up the nose, intranasal vaccines are designed to bolster immune defenses in the mucosa, triggering production of an antibody known as immunoglobulin A, which can block infection. This overwhelming response, called sterilizing immunity, reduces the chance that people will pass on the virus.’

Read here (Scientific American, Mar 1, 2021)

Patently unfair: Can waivers help solve Covid vaccine inequality?

‘The World Trade Organization (WTO) General Council gathered virtually on Monday for the first of two days of talks amid increasing calls from civil society, states and nongovernmental actors to temporarily waive patents for COVID-19 vaccines and other coronavirus-related medical products. Endorsing a waiver on Friday, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said: “If not now, when?”

‘At the core of the discussion stands a proposal submitted in October by South Africa and India to suspend the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for the duration of the coronavirus pandemic. The goal is to facilitate the transfer of technology and scientific knowledge to developing countries to ramp up the global production of vaccines and other necessary equipment.’

Read here (Aljazeera, Mar 1, 2021)

China approves two more domestic Covid-19 vaccines for public use

‘China’s medical products regulator said on Thursday that it had approved two more COVID-19 vaccines for public use, raising the number of domestically produced vaccines that can be used in China to four. The two newly cleared vaccines are made by CanSino Biologics Inc (CanSinoBIO) and Wuhan Institute of Biological Products, an affiliate of China National Pharmaceutical Group (Sinopharm).

‘They join a vaccine from Sinovac Biotech approved earlier this month, and another from Sinopharm’s Beijing unit approved last year.

‘Prior to formal approval for wider public use by the National Medical Products Administration, millions of doses of the two Sinopharm vaccines and Sinovac shot had been administered in China’s vaccination program. The program targets select groups of people facing a higher risk of infection.’

Read here (Reuters, Feb 25, 2021)

IP, vaccine imperialism cause death and suffering, delay recovery

‘Vaccine developers’ refusal to share publicly funded vaccine research findings is stalling broader, affordable vaccinations which would more rapidly contain COVID-19 contagion. The pandemic had infected at least 109 million people worldwide, causing over 2.4 million deaths as of mid-February.

‘Avoidable delays in preventive vaccination are imposing terrible burdens on the world economy and human welfare, with economic disruption demanding more relief and recovery measures. They have cost US$28 trillion in lost output globally, with developed countries contracting by 7% in 2020.’

Read here (IPS News, Feb 16, 2021)

Four principles for urgent pharma action to combat Covid-19

‘Collaboration is needed between pharmaceutical companies and governments to combat the spread of COVID-19 and accelerate access to tests, treatments and vaccines. Norway, which co-chairs the Facilitation Council of the ACT-Accelerator, is committed to ensuring the global vaccination effort is managed effectively. Here are four principles which could ensure equitable access to COVID-19 tools and health products, particularly for low and middle-income countries:

• Principle 1: File for registration rapidly, widely and on the basis of the most rigorous standards
• Principle 2: Price health technologies fairly
• Principle 3: Expand production and supply capacity
• Principle 4: Transparency

Read here (World Economic Forum, Feb 9, 2021)

Vaccine strategy needs rethink after resistant variants emerge, say scientists

‘Leading vaccine scientists are calling for a rethink of the goals of vaccination programmes, saying that herd immunity through vaccination is unlikely to be possible because of the emergence of variants like that in South Africa. The comments came as the University of Oxford and AstraZeneca acknowledged that their vaccine will not protect people against mild to moderate Covid illness caused by the South African variant. The Oxford vaccine is the mainstay of the UK’s immunisation programme and vitally important around the world because of its low cost and ease of use.

‘The findings came from a study involving more than 2,000 people in South Africa. They followed results from two vaccines, from Novavax and Janssen, which were trialled there in recent months and were found to have much reduced protection against the variant – at about 60%. Pfizer/BioNTech and Moderna have also said the variant affects the efficacy of their vaccines, although on the basis of lab studies only.

‘All the vaccines, however, have been found to protect against the most severe disease, hospitalisation and death.’

Read here (The Guardian, Feb 7, 2021)

More Covid vaccine choices mean new equity challenges

‘More questions about priority are likely as the distribution effort matures, says Julie Swann, a vaccine supply chain expert at North Carolina State University. Soon, there should be more than three vaccines—shots from AstraZeneca and Novavax are likely next—and each will come with pros and cons. Even if shots are eventually targeted for one group or another, transparency will be key, she notes. “You can tell people that one is less effective but you wouldn’t have to come back, and the other is more effective but you need a second dose,” she says. Some people may have preferences between one or the other. Maybe some will seek out a different shot elsewhere. Maybe some will wait. But most, she hopes, will see little choice in the range of good options. In the middle of a crisis, a shot is a shot.’

Read here (Wired, Feb 5, 2021)