[dabigv13]

Some more thoughts about this- I doubt these phase III trials will have many/any pregnant women or children. Our knowledge of potential risks in those subgroups may only become apparent after widespread adoption.

More on the Oxford AstraZeneca vaccine's background from the article on adenovirus vector vaccines I linked above-

Some labs have sought to avoid the problem of preexisting immunity altogether by using adenoviruses that don’t normally infect humans but do infect our closest relatives. In the early 2000s, Wilson’s lab at Penn began hunting for chimpanzee adenoviruses, which the researchers isolated from the animal’s feces. Soon after, Ertl’s lab at Wistar began collaborating with Wilson to use the chimpanzee adenoviruses as a novel vaccine vector.

Other groups adopted the idea too. “Chimpanzees are very protected, but stools can be easily collected,” says Stefano Colloca, who worked on adenoviral vectors at Merck Research Laboratories’ center in Rome in the early 2000s. He later helped form a company, Okairos, that was spun out of that work when Merck discontinued its Ad5 programs in 2007.

MilliporeSigma worked with scientists at the University of Oxford to improve the process of manufacturing its chimpanzee adenoviral vector vaccine for COVID-19.
Okairos focused on developing chimpanzee adenoviral vectors that closely resembled human Ad5, and it soon formed a collaboration with a newly founded vaccine center at the University of Oxford called the Jenner Institute. The Oxford team used one of the Okairos chimpanzee-derived vectors to develop a malaria vaccine, which became the first chimpanzee-derived vector to be tested in humans.

In 2012, the Oxford group developed its own chimpanzee-derived vector, dubbed ChAdOx1, based on an adenovirus discovered in chimpanzee feces. The Oxford team went on to create the spin-off company Vaccitech in 2016 and has developed experimental vaccines for a number of diseases, including AIDS, malaria, tuberculosis, and Middle East respiratory syndrome, which is caused by the MERS coronavirus.

A small safety study of that MERS vaccine was conducted in 2018. The results, published this April, showed that most of the 24 people in the trial still had T cells that targeted the MERS virus 12 months after a single injection of the vaccine. They also still had elevated levels of antibodies a year later. But only about half the people who got the highest dose of the vaccine had antibodies that neutralized the MERS virus in lab experiments.

That MERS work allowed the Oxford team to move fast on a COVID-19 vaccine, which essentially swaps in the genetic instructions for the SARS-CoV-2 spike protein. To improve the manufacturing process for its vaccine, Oxford enlisted the help of MilliporeSigma, which will supply equipment to multiple contract manufacturers that could collectively develop tens of millions of doses of the vaccine.

In July, Okairos, which has since morphed into a company now called ReiThera, plans to start a clinical trial of its own COVID-19 vaccine, which is based on an adenovirus discovered in gorilla feces. The biggest drawback to the great-ape adenoviral vector vaccines may be their lack of prior testing in humans. Before the coronavirus pandemic, Oxford’s ChAdOx1 vector had been given to only about 320 people, and ReiThera’s new gorilla-derived vector has never been tested in humans. Although preexisting immunity could limit the effectiveness of the Ad5- and Ad26-based vaccines, at least their developers have a better idea of their vectors’ safety.

I don't mean to be alarmist. There is very sound science behind all these vaccines I'm sure. But we should be cognizant that they are novel.

[dabigv13]

Some more thoughts about this- I doubt these phase III trials will have many/any pregnant women or children. Our knowledge of potential risks in those subgroups may only become apparent after widespread adoption.

More on the Oxford AstraZeneca vaccine's background from the article on adenovirus vector vaccines I linked above-

Some labs have sought to avoid the problem of preexisting immunity altogether by using adenoviruses that don’t normally infect humans but do infect our closest relatives. In the early 2000s, Wilson’s lab at Penn began hunting for chimpanzee adenoviruses, which the researchers isolated from the animal’s feces. Soon after, Ertl’s lab at Wistar began collaborating with Wilson to use the chimpanzee adenoviruses as a novel vaccine vector.

Other groups adopted the idea too. “Chimpanzees are very protected, but stools can be easily collected,” says Stefano Colloca, who worked on adenoviral vectors at Merck Research Laboratories’ center in Rome in the early 2000s. He later helped form a company, Okairos, that was spun out of that work when Merck discontinued its Ad5 programs in 2007.

MilliporeSigma worked with scientists at the University of Oxford to improve the process of manufacturing its chimpanzee adenoviral vector vaccine for COVID-19.
Okairos focused on developing chimpanzee adenoviral vectors that closely resembled human Ad5, and it soon formed a collaboration with a newly founded vaccine center at the University of Oxford called the Jenner Institute. The Oxford team used one of the Okairos chimpanzee-derived vectors to develop a malaria vaccine, which became the first chimpanzee-derived vector to be tested in humans.

In 2012, the Oxford group developed its own chimpanzee-derived vector, dubbed ChAdOx1, based on an adenovirus discovered in chimpanzee feces. The Oxford team went on to create the spin-off company Vaccitech in 2016 and has developed experimental vaccines for a number of diseases, including AIDS, malaria, tuberculosis, and Middle East respiratory syndrome, which is caused by the MERS coronavirus.

A small safety study of that MERS vaccine was conducted in 2018. The results, published this April, showed that most of the 24 people in the trial still had T cells that targeted the MERS virus 12 months after a single injection of the vaccine. They also still had elevated levels of antibodies a year later. But only about half the people who got the highest dose of the vaccine had antibodies that neutralized the MERS virus in lab experiments.

That MERS work allowed the Oxford team to move fast on a COVID-19 vaccine, which essentially swaps in the genetic instructions for the SARS-CoV-2 spike protein. To improve the manufacturing process for its vaccine, Oxford enlisted the help of MilliporeSigma, which will supply equipment to multiple contract manufacturers that could collectively develop tens of millions of doses of the vaccine.

In July, Okairos, which has since morphed into a company now called ReiThera, plans to start a clinical trial of its own COVID-19 vaccine, which is based on an adenovirus discovered in gorilla feces. The biggest drawback to the great-ape adenoviral vector vaccines may be their lack of prior testing in humans. Before the coronavirus pandemic, Oxford’s ChAdOx1 vector had been given to only about 320 people, and ReiThera’s new gorilla-derived vector has never been tested in humans. Although preexisting immunity could limit the effectiveness of the Ad5- and Ad26-based vaccines, at least their developers have a better idea of their vectors’ safety.

I don't mean to be alarmist. There is very sound science behind all these vaccines I'm sure. But we should be cognizant that they are novel.