Pfizer withdraws vaccine application in India [after failing to present needed information to experts]

‘Pfizer Inc says it has withdrawn its application for emergency use of its COVID-19 vaccine in India. The company said Friday that it participated in a meeting of experts of the drug regulator on Feb. 3. Based on the deliberation of that meeting and “our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time,” it said in a statement.

‘The company was the first to approach the Indian regulator in December for its messenger RNA vaccine that it has developed with Germany’s BioNTech. They were closely followed by applications for two other vaccines --- a version of the AstraZeneca made by Serum Institute of India and another by Indian company Bharat Biotech -- which eventually got the nod for emergency use on Jan. 3. However, India’s Health Ministry has said that Pfizer hadn’t made its presentation to experts who needed to clear the vaccine, before the regulator could green-light its use in India.’

Read here (The Independent, Feb 6, 2021)

The vaccine alternatives for people with compromised immune systems

‘While the exact number of the immunocompromised worldwide is unknown, estimates suggest that about 10 million live in the U.S. alone, or around 3 percent of the national population. The number encompasses a diverse range of vulnerabilities, including rare genetic immune deficiencies, chronic illnesses that impair the immune system such as rheumatoid arthritis, and cancer and organ-transplant patients who must take immune-suppressing medications.

‘For them, vaccines will not be effective, because they are incapable of making their own antibodies to neutralize the SARS-CoV-2 virus. Instead, pharmaceutical companies around the world are racing to develop alternative treatments that bypass the immune system altogether.

‘The most common option is called monoclonal antibody treatments. These artificially generated antibodies mimic the body’s natural immune response by binding to key sites on the virus’ spike protein, preventing it entering cells and reproducing. Companies including AstraZeneca, Regeneron, and Eli Lilly are currently testing whether monoclonal antibodies can protect immunocompromised people from SARS-CoV-2.’

Read here (National Geographic, Feb 4, 2021)

Can you still transmit Covid-19 after vaccination?

‘In fact, most vaccines don't fully protect against infection, even if they can block symptoms from appearing. As a result, vaccinated people can unknowingly carry and spread pathogens. Occasionally, they can even start epidemics. 

"Effective" or "sterilising" immunity: There are two main types of immunity you can achieve with vaccines. One is so-called "effective" immunity, which can prevent a pathogen from causing serious disease, but can't stop it from entering the body or making more copies of itself. The other is "sterilising immunity", which can thwart infections entirely, and even prevent asymptomatic cases. The latter is the aspiration of all vaccine research, but surprisingly rarely achieved.

What type of immunity do the Covid-19 vaccines provide? "In a nutshell we don't know, because they’re too new," says Neal. So far, the available Covid-19 vaccines have not been judged primarily on their ability to prevent transmission – though this is now being evaluated as a secondary endpoint for many of them. Instead, their efficacy was assessed by whether they could prevent symptoms from developing. "This means that we set our targets kind of pragmatically," says Danny Altmann, professor of immunology at Imperial College London.’

Read here (BBC, Feb 4, 2021)

Efficacy of the AstraZeneca-Oxford University vaccine: A preprint for The Lancet

‘A study (preprint for The Lancet) of data from the Phase 3 clinical trials of the AstraZeneca-Oxford University vaccine evaluated vaccine efficacy after a single dose and for alternate timing for the booster dose. Notably, the UK adapted the timing for the booster dose from 4 weeks after the first dose—which is how the vaccine was designed to be administered and the timing used for clinical trials—to 12 weeks in an effort to provide the first dose to as many people as possible. This study assessed the vaccine’s efficacy in participants who received the 2 doses between 4 and 12 weeks apart.

‘The researchers found that the efficacy after the first dose did not wane in the first 12 weeks. A single dose of the vaccine was 76% efficacious in preventing symptomatic COVID-19 disease in the first 90 days after vaccination, although it was associated with a substantial decrease in efficacy with respect to preventing asymptomatic infection. Notably, however, the additional asymptomatic infections could potentially be among participants who would have otherwise developed COVID-19 symptoms. Additionally, the efficacy in preventing symptomatic disease was higher in participants who received the booster dose later than in those who received it earlier. Vaccine efficacy was 82.4% among participants who received their booster dose 12 weeks or longer after the first dose, compared to 54.9% in those who received their 2 doses less than 6 weeks apart. These results provide support for vaccination plans that delay the booster dose beyond the intended 4 weeks, considering that the immunity conferred after the first dose appears to be relatively stable over the first several months and the overall protection appears to increase with an increased time between the prime and booster doses.

‘The researchers also found that vaccination was associated with an overall reduced risk of infection—54.9% efficacy for 2 doses and 67% efficacy for 1 dose—which provides evidence that the vaccine could also provide protection against SARS-CoV-2 transmission. The role of SARS-CoV-2 vaccines in mitigating transmission risk remains uncertain, but these findings provide a promising indication that vaccination could reduce community spread of the virus, which would be a major tool to bring the pandemic under control.’

**The above summary was contained in an update of Feb 5, 2021, on the COVID-19 pandemic from the Johns Hopkins Center for Health Security 

• Single dose administration, and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine

Read here (The Lancet, Feb 1, 2021)

German officials say AstraZeneca vaccine shouldn't be given to over-65s, citing lack of data

‘Germany's vaccine commission said the AstraZeneca coronavirus vaccine should not be given to people older than 65 years, amid a bitter dispute between the European Union and the drugmaker over delayed supplies.

‘The Standing Committee on Vaccination (STIKO) at Germany's Robert Koch Institute (RKI), the country's main public health authority, found there is insufficient data on the effectiveness of the vaccine, developed by AstraZeneca and the University of Oxford, for this age group, according to a statement from the interior ministry on Thursday. "Due to the small number of study participants in the age group ≥65 years, no conclusion can be made regarding efficacy and safety in the elderly. This vaccine is therefore currently recommended by STIKO only for persons aged 18-64 years," the panel said in its recommendation.’

Read here (CNN, Jan 28, 2021) 

Thailand: AstraZeneca vaccine approved, 50,000 doses due in February

‘The [Thai] Food and Drug Administration (FDA) has approved the emergency use of AstraZeneca Covid-19 vaccine and 50,000 doses of it will arrive in Thailand in February. FDA secretary-general Paisarn Dunkum said on Thursday that the FDA approved the registration of the vaccine, produced in Italy by AstraZeneca Co, on Wednesday after the firm had submitted nearly 10,000 pages of its documents for vaccine registration for emergency use on Dec 22 last year...

‘A total of 50,000 doses of the vaccine will arrive in Thailand in February. The import licence and vaccine registration will be valid for one year. A Reuters source said the approval applied only to doses manufactured overseas.’

Read here (Bangkok Post, Jan 21, 2021)

Scientists call for pause on AstraZeneca vaccine rollout

‘The Australian and New Zealand Society for Immunology says the federal government should immediately pause the planned rollout of the AstraZeneca vaccine because it may not be effective enough to generate herd immunity.

‘Phase three clinical trials of the vaccine, which is the centrepiece of Australia's vaccination strategy, show it is only 62 per cent effective in preventing COVID-19 when given in the recommended dose. Trials suggest vaccines from Pfizer and Moderna are about 95 per cent effective.’

Read here (Sydney Morning Herald, Jan 12, 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)

India bars virus vaccine maker from exporting

‘India will not allow the export of the Oxford University-AstraZeneca coronavirus vaccine for several months, the head of Serum Institute of India, which has been contracted to make 1 billion doses of the vaccine for developing nations, said Sunday.

‘With rich nations reserving most of the vaccines that will be made this year, Serum Institute — the world’s largest vaccine manufacturer — is likely to make most of the inoculations for developing countries. The ban on exports, however, means that poorer nations will probably have to wait a few months before receiving their first shots.’

Read here (AP, Jan 4, 2021)

Special Reuters report: How a British Covid-19 vaccine went from pole position to troubled start

‘Much was riding on the Oxford vaccine, a British-led endeavour also involving UK drugs firm AstraZeneca. Prime Minister Boris Johnson’s government was desperate for a success story after its early mishandling of the pandemic contributed to one of the world’s highest death tolls from COVID-19 - around 65,000 by mid-December. The government has secured 100 million doses. On Nov. 23, Oxford and AstraZeneca delivered positive news. They announced that the regimen of a half dose followed by a full dose booster appeared to be 90% effective in preventing COVID-19. Two full doses scored 62%. Oxford researchers have said they aren’t certain why the half-dose regimen was much more effective.

‘Johnson called the vaccine team and tweeted his thanks “for their brilliant work.” He went on, “These results are incredibly encouraging and a major step forward in our fight against COVID-19.” Oxford and AstraZeneca are now hoping for quick authorization by Britain’s regulator. But questions about the trial and the results won’t go away...’

Read here (Reuters, Dec 24, 2020)

European Commission embarrassed by Covid-19 vaccine price leak

‘The tweeted information gave the following price per dose for each vaccine maker, in either euros or US dollars according to the respective contract:

1. AstraZeneca: €1.78
2. Johnson & Johnson: US$8.50
3. Sanofi/GlaxoSmithKline: €7.56
4. Pfizer/BioNTech: €12.00
5. Curevac: €10.00
6. Moderna: US$18.00’

Read here (Malay Mail, Dec 18, 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)

WHO to make decisions on Pfizer, Moderna, AstraZeneca COVID-19 vaccines in weeks

‘The World Health Organization expects to make decisions on whether to give emergency use approval to COVID-19 vaccines from Pfizer, Moderna and AstraZeneca in the coming weeks, its chief scientist said on Friday (Dec 11).

‘Soumya Swaminathan said the global health body could decide on Pfizer's vaccine candidate in the next "couple of weeks", and later said it could also review Moderna's and AstraZeneca's candidates in a few weeks.’

Read here (Channel News Asia, Dec 12, 2020)

Covid: Trials to test combination of Oxford and Sputnik vaccines

‘UK and Russian scientists are teaming up to trial a combination of the Oxford-AstraZeneca and Sputnik V vaccines to see if protection against Covid-19 can be improved. Mixing two similar vaccines could lead to a better immune response in people. The trials, to be held in Russia, will involve over-18s, although it's not clear how many people will be involved.’

Read here (BBC, Dec 11, 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)

Neutralising the threat of Covid-19

Informative and interesting talk with Q&A relevant to Malaysia, live-streamed on Dec 7, 2020. Professor William James, is Professor of Virology and Tutor in Medical Sciences, Jeffrey Cheah Professorial Fellow, and is attached to The Sir William Dunn School of Pathology. He is currently contributing to the work on the Oxford University AstraZeneca COVID-19 vaccine. The talk is moderated by Prof. Abhi Veerakumarasivam, Co-Chair & Professor, ASEAN Young Scientists Network & Sunway University.

View here (YouTube, Dec 7, 2020)

What you need to know about the Pfizer, Moderna and AstraZeneca vaccines

‘All three drugmakers have moved at record speed, and the first shots of the Pfizer and Moderna vaccines could be given in the coming weeks. This article answers a list of questions that ordinary people need to know before they commit to the vaccinations.’

Read here (Washington Post, Nov 30, 2020)

AstraZeneca says its Covid-19 vaccine needs 'additional study'

‘The head of British drug manufacturer AstraZeneca said on Thursday (Nov 26) further research was needed on its COVID-19 vaccine after questions emerged over the protection it offers, but the additional testing is unlikely to affect regulatory approval in Europe.

‘Instead of adding the trial to an ongoing US process, AstraZeneca might launch a fresh study to evaluate a lower dosage of its vaccine that performed better than a full dosage, AstraZeneca chief executive Pascal Soriot was quoted as saying in a Bloomberg News report.’

Read here (Channel News Asia, Nov 27, 2020)

Scientists are puzzling over one crucial number as they evaluate the Oxford-AstraZeneca coronavirus vaccine

‘The Oxford-AstraZeneca vaccine candidate is given to people as two doses, at least one month apart. The trial data, which comes from late-stage studies in the UK, Brazil and South Africa, suggests that the vaccine is 62% effective if people get two full doses, but 90% effective when they get a half-strength version of the first dose. The information was provided in a press release and hasn't been published in a peer-reviewed journal. AstraZeneca and Oxford said they're submitting the results for review and publication.’

Read here (Business Insider, Nov 24, 2020)

Oxford vaccine: How did they make it so quickly?

‘Ten years' vaccine work achieved in about 10 months. Yet no corners cut in designing, testing and manufacturing... They are two statements that sound like a contradiction, and have led some to ask how we can be sure the Oxford vaccine - which has published its first results showing it is highly effective at stopping Covid-19 - is safe when it has been made so fast. So, this is the real story of how the Oxford vaccine happened so quickly.’

Read here (BBC, Nov 23, 2020)