The blood-clot problem is multiplying

‘Whether the blood issues are ultimately linked to only one vaccine, or two vaccines, or more, it’s absolutely crucial to remember the unrelenting death toll from the coronavirus itself—and the fact that COVID-19 can set off its own chaos in the circulatory system, with blood clots showing up in “almost every organ.” That effect of the disease is just one of many reasons the European Medicines Agency has emphasized that the “overall benefits of the [AstraZeneca] vaccine in preventing COVID-19 outweigh the risks of side effects.” The same is true of Johnson & Johnson’s. These vaccines are saving countless lives across multiple continents.

‘But it’s also crucial to determine the biological cause of any vaccine-related blood conditions. This global immunization project presents a lot of firsts: the first authorized use of mRNA vaccines like the ones from Pfizer and Moderna; the first worldwide use of adenovirus vectors for vaccines like AstraZeneca’s, Johnson & Johnson’s, and Sputnik V; and the first attempt to immunize against a coronavirus. Which, if any, of these new frontiers might be linked to serious side effects? Which, if any, of the other vaccines could be drawn into this story, too? How can a tiny but disturbing risk be mitigated as we fight our way out of this pandemic? And what might be the implications for vaccine design in the years to come?

‘To answer these questions, scientists will have to figure out the biology behind this rare blood condition: what exactly causes it; when and why it happens. This is not an easy task. While the evidence available so far is fairly limited, some useful theories have emerged...

• Theory 1: Platelet problems
• Theory 2: The spike’s the problem
• Theory 3: A suspect sequence
• Theory 4: The mixed bag

Read here (The Atlantic, Apr 17, 2021)

From Pfizer to Moderna: Who's making billions from Covid-19 vaccines?

‘Among the biggest winners will be Moderna and Pfizer – two very different US pharma firms which are both charging more than $30 per person for the protection of their two-dose vaccines. While Moderna was founded just 11 years ago, has never made a profit and employed just 830 staff pre-pandemic, Pfizer traces its roots back to 1849, made a net profit of $9.6bn last year and employs nearly 80,000 staff.

‘But other drugmakers, such as the British-Swedish AstraZeneca and the US pharma Johnson & Johnson, have pledged to provide their vaccines on a not-for-profit basis until the pandemic comes to an end.’

Also carried in this story are: Sinovac, Sputnik V, Novavax, CureVac 

Read here (The Guardian, Mar 6, 2021)

It’s time to trust China’s and Russia’s vaccines

‘The fact is that no Covid-19 vaccine has been developed or released as transparently as it should have been. And while China and Russia may have botched their rollouts more than some Western companies, that doesn’t necessarily mean their vaccines are shoddy. The mounting evidence showing that the Chinese and Russian vaccines are reliable should be taken seriously, and fast, especially considering supply issues throughout the world...

‘What’s more, most big pharmaceutical companies in the West have resisted licensing their vaccines to non-Western manufacturers, and several wealthy countries are blocking a proposal by India and South Africa that the World Trade Organization temporarily suspend some intellectual property protections for Covid-19-related vaccines and treatments.

‘On the other hand, according to our latest analysis of data provided by the analytics firm Airfinity, Sinovac has already signed deals to export this year more than 350 million doses of its vaccine to 12 countries; Sinopharm, around 194 million doses to 11 countries; Sputnik V, about 400 million doses to 17 countries. All three manufacturers have stated publicly that they will have the capacity to produce up to 1 billion doses each in 2021. And all three have licensed their vaccines to local manufacturers in several countries.’

Read here (New York Times, Feb 5, 2021)

Sputnik V ‘91·6% efficacious, well tolerated’: Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia

‘Our interim results of the phase 3 Gam-COVID-Vac trial show that the vaccine is 91·6% (95% CI 85·6–95·2) efficacious against COVID-19 (from day 21 after first dose, the day of receiving second dose). Our results also showed that the vaccine was 100% (95% CI 94·4–100) efficacious against severe COVID-19, although this was a secondary outcome so the results are preliminary. The vaccine was well tolerated, with 45 (0·3%) of 16 427 participants in the vaccine group reporting serious adverse events, all of which were considered not related to the vaccine... 

‘The vaccine induced robust humoral (n=342) and cellular (n=44) immune responses in all age strata. Notably, there were a few non-responders in the vaccine group (six of 342), possibly due to immunosenescence in older people, individual characteristics of the formation of an immune response, or concomitant immunological disorders.’

Read here (The Lancet, Feb 2, 2021) 

Pharmaniaga, Duopharma to supply 18.4m doses of vaccines

‘Malaysia has secured deals to acquire 18.4 million doses of Covid-19 vaccines through Pharmaniaga Bhd and Duopharma Biotech Bhd. In separate announcements, Pharmaniaga said it would be supplying 12 million doses of Covid-19 vaccines developed by China’s Sinovac Life Sciences Co Ltd, while Duopharma said it would supply 6.4 million doses of Sputnik V developed by Russia’s Gamaleya Research Institute to the government.

‘Both companies yesterday said they had entered into a term sheet agreements to supply the Covid-19 vaccines to the Health Ministry. Pharmaniaga said it would begin manufacturing Sinovac Covid-19 vaccines in February and will deliver the bottled vaccines to identified hospitals and other healthcare facilities nationwide by April 2021.

Read here (The Star, Jan 27, 2021) 

Chinese and Russian vaccines in high demand as world scrambles for doses

‘Sales represent coup for Beijing and Moscow, even as concerns over pharma standards linger... 

‘Chinese and Russian manufacturers are seeing growing appetite from foreign buyers for their Covid-19 vaccines as the international scramble for jabs intensifies, despite lingering concerns over incomplete trial data and the rigour of domestic approval processes.

‘Russia’s Gamaleya Research Institute of Epidemiology and Microbiology has agreed to sell its Sputnik V vaccine to countries including Algeria, Argentina, Saudi Arabia and Brazil, while the two leading Chinese manufacturers, Sinopharm and Sinovac Biotech, have signed deals with more than a dozen countries including Bahrain, United Arab Emirates, Egypt, Philippines, Indonesia and Hungary.’

Read here  (Financial Times, Jan 18, 2021) 

After months of bashing Russia’s Sputnik V vaccine, Western journalists in Moscow line up to be inoculated against Covid-19

‘Since Russian President Vladimir Putin announced the registration of Sputnik V, the world's first vaccine against Covid-19, sections of the Western media have taken aim at a formula they’ve dubbed both dangerous and ineffective. However, in recent weeks, Moscow-based representatives of the very same outlets have lined up to receive the much-maligned Sputnik V. Living in Russia, it is no surprise that the correspondents have a much more realistic view of the country than their New York and London-based superiors.

‘On Friday, the New York Times’ Andrew Kramer revealed he had received his first dose of Sputnik V, praising the “bona fide accomplishment for Russian scientists continuing a long and storied practice of vaccine development,” even noting that Moscow has avoided some of the logistical problems seen in the West.’

Read here (RT, Jan 14, 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)

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)

The efficacy of the Sputnik V vaccine is 91.4%, based on the second interim analysis

‘The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that has proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades - while the history of the use of human adenoviruses in vaccine development began in 1953. More than 100,000 people have received approved and registered drugs based on human adenoviral vectors. The uniqueness of the Russian vaccine lies in the use of two different human adenoviral vectors which allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.’

Read here (Sputnik V, Nov 23, 2020)