Thrombocytopenia following Pfizer and Moderna SARS‐CoV‐2 vaccination.
https://onlinelibrary.wiley.com/doi/10.1002/ajh.26132
This data is well over a month old now. I presume that there have been further updates but haven’t yet seen them. You’d struggle to know of them as an issue though.
Meanwhile…
The WHO on Thursday criticised Europe for its sluggish vaccination programme, which trails well behind those of the UK and the US.
One in 10 people in the bloc have received a single dose, while just 4 per cent have been given two.
“Vaccines present our best way out of this pandemic, however, the distribution of these vaccines is unacceptably slow," said Dr Hans Kluge, the WHO’s regional director for Europe.
"We must speed up the process by ramping up manufacturing, reducing barriers to administering vaccines, and using every single vial we have in stock now.”
He said that Europe’s virus situation was “more worrying than we have seen in several months”.
Last week, increased transmission of Covid-19 was recorded in the majority of countries on the continent, with 1.6 million new cases and nearly 24,000 deaths.
The WHO said cases were rising in every age group, except in people aged 80 and older.
Europe is the second most affected by coronavirus of all the world’s regions, with its number of deaths approaching one million and the total number of cases set to surpass 45 million.
The head of the European Medicines Agency said on Wednesday that there was “no evidence” to support limiting the use of the AstraZeneca-Oxford coronavirus vaccine, as Germany did after new concerns over blood clots.
But EMA executive director Emer Cooke said the Amsterdam-based agency continued to study reports of new cases and would provide a further assessment next week.
“According to the current scientific knowledge, there is no evidence that would support restricting the use of this vaccine in any population,” Ms Cooke said.
The agency’s assessment was based on 62 cases of unusual blood clots worldwide, including 14 deaths, reported to the EMA by March 22. Those figures included a “significant number” of cases reported from Germany, she said.
More than for the Pfizer vaccine which carries on from your comment BTW!!! 
But AZ does not create a fourfold increase in risk of bloodclots over Pfizer, as you claimed. Both vaccines act to reduce the risk of bloodclots.
More on the Halix (Netherlands) facility:
Google translate:
Difficult start-up of Halix plant contributed to AstraZeneca’s delivery problems
Thieu Vaessen 31 Mar.
The Halix factory in Leiden, which makes corona vaccines for AstraZeneca, faced numerous starting problems last year. As a result, the company struggled to comply with all laws and regulations. This is evident from conversations with former Halix employees. The slow start explains some of the delivery problems that AstraZeneca is currently facing.
In brief
Halix from Leiden makes corona vaccines for AstraZeneca.
The factory that opened in 2019 faced many starting problems.
According to former employees, Halix often pretended to be bigger and more important to the outside world than the company could live up to.
At the start of the plant, Halix was not familiar with the strict rules for the production of medicines, the former employees say. One of them speaks of ‘amateurism’ and another of ‘a doctor who does not know what a fever is’.
The statements about starting problems at Halix shed a different light on the reports this week that the Netherlands missed an opportunity to invest in the Leiden factory in April last year. According to those reports, the Netherlands could possibly have secured a faster delivery of corona vaccines. The former employees question that conclusion. According to them, Halix often pretended to be bigger and more important to the outside world than the company could live up to.
Diplomatic quarrel
The vaccines that Halix makes earlier this month were the cause of a diplomatic row between the European Union and the British. The question was who was entitled to the vaccines, after which it turned out that the production of Halix had not yet been approved for use in the European Union. British approval was also lacking, and as far as we know is still lacking.
The European approval by the EMA came last week. But that did not happen automatically. The former employees report that Halix ran into many problems due to a hasty start of its new factory, which was commissioned in November 2019. AstraZeneca and its partner the University of Oxford are the first customers.
Halix is a subsidiary of HAL Allergy, a pharmaceutical company owned by the German family concern Droege Group. The subsidiary was founded in 2012 and operated from the HAL building in Leiden until the end of 2019. There, Halix has two small production areas of approximately fifty square meters. Halix had the new factory built on Tinbergenweg, opposite HAL Allergy. It has a floor space of 6,700 square meters.
Regular vaccination campaigns
Initially, Halix only wanted to make trial vaccines for clinical research in the new facility, but management increased its ambitions as the corona pandemic spread. The company decided in the summer to start producing vaccines for regular vaccination campaigns. This step necessitated a rapid expansion of production capacity. According to the former employees, the factory was ‘absolutely not’ ready for that.
The former employees also report that the Health and Youth Care Inspectorate (IGJ) paid a first inspection visit to Halix in August last year. When asked, the IGJ confirms that an inspection visit did indeed take place at the time. That has only resulted in partial approval. “The facility was not yet completely ready,” said a written response from the IGJ to questions from the FD.
The IGJ fully approved the new Halix plant early this year, after a second inspection visit in December. The report on that visit is confidential, much to the disappointment of the former Halix employees. The IGJ says it will not make the report on the new factory public, because the approval only concerns an extension of an existing permit.
Major shortcomings
Three years ago, the inspectorate did publish a so-called surveillance document after a visit to HAL Allergy and the first Halix location. The IGJ then issued an unqualified statement, but also identified a series of “significant” shortcomings. For example, the inspectorate noted that Halix did not have internal or external controls carried out.
In the new Halix factory, the management did not adhere to standard rules in the pharmaceutical industry, according to the former employees. These rules must prevent errors in the supply of raw materials, water quality, air treatment and the description of product specifications. Staff training was also inadequate and the company faced understaffing.
Inexperienced contractor
Some starting problems, according to former employees, were caused by the new building being entrusted to an inexperienced contractor. The construction company had never built a pharmaceutical manufacturing facility before. Partly because of this, interim control steps that are required were missing, for example when laying pipes and other facilities. The former employees speak on the condition that their name is not mentioned.
After opening the factory at the end of 2019, the management hoped to receive approval within a few months, according to the former employees. “That was absolutely unrealistic,” said one of them. The wish of the management to accelerate, led to internal tensions and the premature departure of several employees. A vacancy for Director of QA (quality management) has been open for some time.
In a brief response, Halix said on Wednesday that after the completion of the new factory at the end of 2019, ‘a period of qualification and validation has taken place’. The company also reports that the plant was inspected “on schedule” in August and December, “after which approval was obtained.”
High expectations
Expectations about Halix were high last year. The company was named as a supplier in the contracts that AstraZeneca concluded with both the European Union and the United Kingdom. That was in August last year. The EU Member States therefore had to share Halix production with the United Kingdom. At first, however, there was not much to divide. The vaccines from the Halix factory could not be used, because Halix did not yet have EU approval last year. After approval by the IGJ in January, the EMA gave the green light in March. EMA’s fiat does not mean that AstraZeneca’s delivery problems are now over. Halix’s production capacity is too small for that.
After a visit to the Leiden factory, EU Commissioner Thierry Breton reported that Halix has a bulk production of 5 million doses per month. That number was later confirmed by Halix. It is not clear to what extent Halix also manages to produce 5 million doses per month. Nor is it known where the doses already produced are now located. AstraZeneca has delivered only about 30 million vaccines to the European Union to date. The company claims that it cannot meet the agreements because suppliers are faced with setbacks in the complex organic production process.
AstraZeneca was originally expected to deliver 300 million doses to the European Union in the first six months of this year. That equates to 50 million doses per month. Halix is one of four factories authorized to produce the AstraZeneca vaccine in bulk for the EU Member States.
And an interesting article from February by Politico
The British-Swedish drugmaker is signing new manufacturing deals.
While AstraZeneca has other producers within Europe, only three were approved by the European Medicines Agency | Jens Schlueter/AFP via Getty Images
February 12, 2021 6:14 pm
AstraZeneca is scrambling to find more manufacturers to produce its coronavirus vaccine in Europe after the drugmaker’s bet on a limited number of sites fell short.
By the end of January, only one continental plant — located in Seneffe in Belgium — was authorized to manufacture the drug substance for the vaccine coveted by governments across Europe, alongside two sites in the U.K. and U.S.
After announcing the company would be unable to deliver nearly two-thirds of the 100 million doses it promised the EU by the end of March, AstraZeneca CEO Pascal Soriot initially pointed the finger at the Belgian plant, now owned by U.S. company Thermo Fisher Scientific.
But Thermo Fisher this week said it had done what it was obliged to under its contract with the drugmaker. “We have complied with all the contractual requirements we have with AstraZeneca,” Cedric Volanti, Thermo Fisher’s vice president for EU told a press conference Wednesday.
Now, the British-Swedish drugmaker is signing deals to increase the supply for the EU, including one with Germany’s IDT Biologika to start manufacturing the drug substance for the EU.
A successful strategy “has to have multiple sites,” one EU official said. “It appears now the U.K. is holding onto their plants, [and AstraZeneca was] relying solely on Thermo Fisher Scientific to manufacture for everybody — it’s impossible.”
The official, who wished to remain anonymous, said that while the plant’s production was running thousands of doses behind, inspections had revealed no serious issues that would leave it millions of doses off target. The Belgian factory was “a bit behind schedule” but it was “never their intention to cover the whole of the EU drug substance manufacturing — it’s unfeasible,” the official said.
While AstraZeneca has other producers within Europe, only three were approved by the European Medicines Agency to manufacture the substance for the vaccines, according to the conditional marketing authorization application dated January 29.
Alongside the plant owned by Thermo Fisher Scientific (listed by its original name Henogen), those are Oxford Biomedica in the U.K. and Catalent in the U.S. Another plant from AstraZeneca subsidiary MedImmune in the Netherlands is listed to carry out the batch release, or quality checks, of the vaccines.
A company can later amend its application to include more plants, however. Soriot told a press conference in January that the “bottleneck” for the company was “on the drug substance side and manufacturing the vaccine itself,” rather than at the later manufacturing stage, called fill-finish.
The CEO acknowledged the company would not be able to increase capacity “in the near term, because drugs substance takes … a relatively long time” to produce.
AstraZeneca declined to comment on whether it had failed to adequately plan to deliver the volumes of doses promised to the EU.
In January, when AstraZeneca announced the 60 percent cut in vaccine supply to the EU, Commission officials lambasted the company for exporting its EU-marked doses to the U.K. and then refusing to use any from the British supply chain to meet the shortfall on the Continent.
After a fight with the Commission over the delivery shortages, AstraZeneca announced it would be able to supply 40 million doses to the EU by the end of March. Some of those doses are coming from the U.S. site, located in Maryland.
When the Belgian plant — previously owned by Novasep — began producing the drug substance for AstraZeneca’s vaccine in 2020, its dose production volumes were roughly 4 million doses per month, according to the EU official. That rose to 8 million a month in January following an expansion.
The University of Oxford, which developed the shot together with AstraZeneca, contracted a plant in the Netherlands owned by company Halix as early as April to produce the drug substance.
This plant was only intended to be used for the U.K. supply chain, the official and a second person with knowledge of the U.K.’s contract with AstraZeneca confirmed. Both officials also said it was unclear whether the Dutch plant had yet produced any doses.
Dutch manufacturer Halix did not respond to requests for comment.
Similarly, IDT Biologika, based in Dessau, Germany, which handles fill-finish, has only ever done this work for the U.K. vaccine supply, a spokesperson confirmed. The company has not produced any vaccine for the EU, but it will now make drug substance and, in the future, do fill-finish for the EU under the new deal announced this week.
A different producer based in Italy owned by global manufacturing company Catalent is contracted to do the fill-finish for the EU doses. AstraZeneca also inked a deal in January with Madrid-based Insud Pharma to add fill-finish capacity for the EU.
The company is reportedly in talks with a Chinese company called Wuxi to produce more vaccine drug substance for the EU as well as a Russian group called R-Pharm. AstraZeneca declined to confirm this.
Edited to add: And now it’s back in the news…
These mRNA vaccines, whilst more expensive to produce and seemingly more resource-intensive to store (and thus more costly), do appear to be extremely effective. Hopefully Moderna will show similar results (I think the data suggests it will) and that Curevac will also be equally effective.
Another big advantage of these is that theoretically they should be far easier to modify to deal with variants than more traditionally developed vaccines like AZ
That’s what I understand. It’s what makes the UK (world leader in genetic sequencing) collaboration with Curevac so exciting as its dedicated to developing new mRNA vaccines quickly in response to new Variants of Concern.
I think I saw that they hoped such a process could be achieved in less than two months (maybe quicker) and for it then go to trials. They are currently working on developing vaccines that seek to predict future mutations. IE, if the virus mutated like this that would be really fucking bad, so let’s develop a vaccine against that now, even though the mutation doesn’t yet exist.
Brilliant work they’re doing to get ahead of it all.
What then needs to happen is utilisation of global production capacity in short order and this will require wider collaboration by all pharmaceutical companies, governments and regulatory bodies.
Hugo’s having a few days off…
This means that as of yesterday 31,147,444 of the UK population had received at least one dose of corona vaccine (46.6% of the population). The EU figure is 11.6%.
4,513,458 people had received both doses (6.8%). The EU figure is 4.9%.
Interesting comment, easier and faster?
Yes. It’s just a much more targeted solution to a genetic variant.
The mRNA vaccines and the Novavax one are the ones I find most interesting.
mRNA is interesting because it’s been the therapeutic equivalent of cold fusion - great theoretical potential but considered a practical pipedream. This is a good history of it
The Netherlands; 72.377 jabs, total for this week; 198.854.
That’s quite a way short of the 500k target I think you quoted earlier in the week. Sorry if I’m wrong.
They have 4 more days, forget to mention that the 73 were the day total for yesterday and the 198 for the first 3 days of this week. Don’t think they will make it though.
Hmm…this is about going forward. Whitty is apparently suggesting treating covid like flu and that to allow for a return to normality we’ll have to accept that people will die from it (apparently 25,000 per year would be “tolerable”). Sheesh.
Shouldn’t continuous vaccination programs substantially reduce that figure? It’s more or less the figure that was first given as one which the UK would ‘do well’ to keep under and that was without vaccines.
