Sinovac applies for conditional approval of Covid-19 vaccine in China

‘China's medicine regulator is reviewing a second domestically developed COVID-19 vaccine for conditional approval. The CoronaVac inoculation, developed by Sinovac Biotech, has been given to tens of thousands of people in China under an emergency use program launched in July targeting specific groups with high infection risks. Regulators are also reviewing for approval a similar vaccine created by state-owned China National Pharmaceutical Group, known as Sinopharm...

‘China's COVID-19 vaccines have won approval in a dozen countries for emergency use, but the failure to publish detailed trial data could undermine public trust, a leading Chinese researcher said in a recent interview.

‘Ding Sheng, dean of Tsinghua University's School of Pharmaceutical Sciences and director of the Global Health Drug Discovery Institute (GHDDI), called for the original clinical trial data from Chinese experimental vaccines to be made public so that experts can better assess their efficacy and eliminate lingering safety concerns in China and abroad.’

Read here (Nikkei, Feb 4, 2021)

Covid-19: Novavax vaccine shows 89% efficacy in UK trials

‘A new coronavirus vaccine has been shown to be 89.3% effective in large-scale UK trials. The Novavax jab is the first to show in trials that it is effective against the new virus variant found in the UK, the BBC's medical editor Fergus Walsh said. The PM welcomed the "good news" and said the UK's medicines regulator would now assess the vaccine.’

Read here (BBC, Jan 29, 2021) 

How to redesign Covid vaccines so they protect against variants

‘Some aspiring vaccine makers have had their eye on the threat that escape variants might pose from the start. A team at Gritstone Oncology decided to focus on this potential problem by designing a vaccine that targets multiple sites on several viral proteins, in contrast to first-generation shots that target only the spike protein, says Andrew Allen, president of the company in Emeryville, California. The hope is that the vaccine, which should soon start clinical trials, will make it difficult for the virus to evade immunity because many genetic changes would be necessary for it to do so. “You can either play whack-a-mole and chase the variants, or you can try to get ahead of them,” Allen says.

‘Because updating the construction of existing vaccines is relatively simple, a new RNA vaccine could be designed and manufactured for clinical testing within six weeks, Weissman estimates. But that is only the beginning. “Mass-producing a vaccine is hard. To start all over again will be hard,” says Offit. Some researchers are expecting periodic updates to coronavirus vaccines, as with flu, to become a way of life. “This is not unusual,” says Stanley Plotkin, a consultant who advises companies on vaccines. But it could mean that worries over supply chains and logistics will continue for some time.’

Read here (Nature, Jan 29, 2021)

Just like Pfizer, China says vaccines can beat new strains

‘Virologists and vaccine specialists with China’s National Health Commission (NHC) said on Wednesday they had a detailed plan to upgrade homegrown vaccines against Covid-19 to “version 2.0” within two months to stop the spread of new mutant strains found across the United Kingdom and South Africa.

‘The claim coincided with Pfizer’s announcement on Wednesday that its Covid-19 vaccine works against mutated variants found in the UK and South Africa, according to a lab study. China’s claim comes as local firms SinoPharm and Sinovac crank out their Covid-19 shots for mass inoculations.’

Read here (Asia Times, Jan 28, 2021)

How Gamaleya’s vaccine (Sputnik V) works

‘The Gamaleya Research Institute, part of Russia’s Ministry of Health, developed a coronavirus vaccine known as Sputnik V or Gam-Covid-Vac. Gamaleya announced in December that the vaccine had an efficacy of 91.4 percent. Russia is using it in a mass vaccination campaign, and it is now being distributed in Argentina, Belarus and other countries.’ This story tells you in graphic form how it works...

Read here (New York Times, Jan 8, 2021)

A second Chinese coronavirus vaccine is said to be effective

‘Brazilian officials said Thursday that a coronavirus vaccine made by a Chinese company was effective, bolstering the chances of approval for a second Chinese inoculation that could be rolled out in much of the developing world. Officials in the state of São Paulo, where a prominent medical research institute carried out a large study of the vaccine made by the Beijing-based Sinovac, said the inoculation had an efficacy rate of 78 percent.

‘The vaccine prevented all participants from developing serious and mild complications from the virus, officials said, calling it a highly effective preventive tool. Sinovac Biotech has sold more than 300 million doses to the developing world, filling a gap left by Western countries.’

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

India’s push to use untested vaccine rings alarm bells

‘India’s need for speed in providing a Covid-19 vaccine and attempts to push a locally-produced version through for use before a required phase 3 trial was finished has raised doubts and protests from politicians, scientists and academicians.

‘The Drugs Controller General of India (DCGI) approved the Oxford-AstraZeneca vaccine that’s being produced locally by the Serum Institute of India as Covishield. The world’s largest vaccine manufacturer based in Pune said it can readily provide 50 million vaccines to the government for immediate use and can roll out full production to start supplying the population by March.

‘The DCGI also approved a vaccine produced by Bharat Biotech Ltd along with the Indian Council for Medical Research and the National Institute of Virology named Covaxin for emergency use on a trial basis.’

Read here (Asia Times, Jan 4, 2020)

There are four types of Covid-19 vaccines: Here’s how they work

‘The fight against COVID-19 has seen vaccine development move at record speed, with more than 170 different vaccines in trials. But how are they different from each other and how will they protect us against the disease?

‘There are more vaccine candidates simultaneously in the pipeline for COVID-19 than ever before for an infectious disease. All of them are trying to achieve the same thing – immunity to the virus, and some might also be able to stop transmission. They do so by stimulating an immune response to an antigen, a molecule found on the virus. In the case of COVID-19, the antigen is typically the characteristic spike protein found on the surface of the virus, which it normally uses to help it invade human cells.

‘The four main types of Covid-19 vaccines: There are four categories of vaccines in clinical trials: (1) Whole virus, (2) Protein subunit, (3) Viral vector and (4) Nucleic acid (RNA and DNA). Some of them try to smuggle the antigen into the body, others use the body’s own cells to make the viral antigen.’

Read here (Gavi, as Jan 2021)

Watch here (Gavi, Youtube, as Jan 2021)

Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine

‘This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2.

‘The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline... 

‘The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427. opens in new tab.)’

Read here (New England Journal of Medicine, Dec 30, 2020)

The vaccine news is great, but Big Pharma is still fooling us

‘Heroic work went into the development of the coronavirus vaccines. But that does not mean this industry deserves your affection...

‘I recall feeling, at the start of this pandemic, both horror at the unfolding calamity, and also a small sense of hope that as in other times of hardship, people would find ways to change the world for the better. There was talk of community support, mutual aid and the rediscovery of the positive powers of the state to protect its citizens. Much of that has dimmed now, and it often seems that we simply want relief - to go back to the way the world was before, and as soon as possible.

‘We have to get back to that place. Yet this may be the best chance in our lifetimes to break the hold of an industry that, until recently, was rightly vilified. The public is following these developments closely, and the state support that underwrites pharmaceutical profits couldn't be more obvious: Operation Warp Speed alone has dispensed over US$10 billion to the industry.

‘Pay it to make the vaccine, sure. That's a service. But we shouldn't be afraid to demand more: Public support should mean a public vaccine, one that reaches people as quickly as possible - profitable or not. The pharmaceutical industry wouldn't be able to rake in its profits and restore its reputation without funding that comes from our tax dollars. We shouldn't let Big Pharma forget it.’

Read here (Straits Times, Dec 22, 2020)

Oxford-AstraZeneca vaccine: Bogus reports, accidental finds - the story of the jab

‘In the early hours of Saturday 11 January, Prof Teresa Lambe was woken up by the ping of her email. The information she had been waiting for had just arrived in her inbox: the genetic code for a new coronavirus, shared worldwide by scientists in China. She got to work straight away, still in her pyjamas, and was glued to her laptop for the next 48 hours. "My family didn't see me very much that weekend, but I think that set the tone for the rest of the year," she says...

‘That weekend was the first step on a journey to create a vaccine at lightning speed, for a disease that would, in a matter of months, claim more than 1.5 million lives. I have been following the efforts of the Oxford scientists since the start. There have been dramas along the way, including:

• A rush to charter a jet when a flight-ban prevented vaccine from getting into the country
• Dismay at totally false reports on social media that the first volunteer to be immunised had died
• Concern that falling infection rates over the summer would jeopardise the hope of quick results
• How an initial half-dose of the vaccine unexpectedly provided the best protection
• An admission from the chief of Oxford's partner, drug company AstraZeneca, that it would have run the trials "a bit differently".

Read here (BBC, Dec 14, 2020)

Spotlight on China’s competing Covid vaccines

‘Chinese authorities have already approved multiple Covid-19 vaccines for emergency use in the country, and nearly a million Chinese have already been vaccinated with one candidate. Several local governments are already placing orders for domestically developed vaccines, though the Chinese government hasn’t confirmed how many people it’s aiming to vaccinate as part of emergency approval. The first international shipments of the vaccine, by private Chinese company Sinovac, have also already arrived in Indonesia this week in preparation for a mass vaccination campaign ahead of expected local approval...

‘So who are the companies developing these vaccines in China, and what do we know about them?’ 

Read here (Asia Times, Dec 12, 2020)

Blunders eroded US confidence in early vaccine front-runner

‘On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the F.D.A.’s blessing for the coronavirus vaccine it was developing with the University of Oxford?

‘But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.

‘A few hours after the conference call, the story broke about the halted trials. That was how key F.D.A. officials heard the news, according to people with knowledge of the discussions.’

Read here (New York Times, Dec 8, 2020)

The science behind an RNA vaccine

‘In just 10 months, a vaccine developed by Pfizer and BioNTech has been approved by Britain for emergency use to prevent Covid-19. Another by Moderna is being evaluated for emergency use authorisation by several regulators, including the United States Food and Drug Administration...

‘This 10-month timeline for vaccines to get from concept to licensing is ground-breaking; most take more than 10 years to reach this stage. There are several other RNA vaccines in the pipeline, including the one our team at Duke-NUS Medical School is working on in partnership with Arcturus Therapeutics. Here is the science behind such vaccines...’

Read here (Straits Times, Dec 7, 2020)

UK ready for roll-out but Pfizer CEO 'not certain' if vaccine stops transmission

‘Days after getting back-to-back approvals from the United Kingdom (UK) and Bahrain health regulatory bodies for the emergency use of its coronavirus vaccine, Pfizer Inc CEO Albert Bourla is now "not certain" if the company-made vaccine to prevent the Covid-19 can actually stop the transmission of the infection. The basic.

‘...during an interview with NBC's Lestor Holt, Pfizer CEO, when asked whether a person can still transmit the virus after vaccination, said he was "not certain". "I think this is something that needs to be examined. We are not certain about that right now with what we know," he was quoted as saying.’

Read here (India Today, Dec 6, 2020)

Breaking down Moderna’s Covid-19 patent pledge: Why did they do it?

‘Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine using mRNA, made the following statement regarding enforcement of its patents: “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.”

‘This post examines why Moderna made this patent pledge by examining its mRNA technology, go-to-market status, patent landscape, and market position.’

Read here (IP Watchdog, Nov 11, 2020)