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Weekly Summary: The Israeli vaccine for corona is advancing
Modernity receives emergency approval, Pfizer begins to reap the benefits of its vaccine and competing thoughts re-route.
And what happens to the Israeli vaccine?
Immunologist Dr. Erez Gerti concludes a week in the scientific race to eradicate the corona
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Corona
Vaccine for corona
Pfizer
Modern
The Biological Institute
Dr. Erez Gerty
Friday, 18 December 2020, 07:28
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This week began with the publication of the results of the third phase of the clinical trials in the vaccine being developed by AstraZeneca and Oxford University.
Their vaccine is based on a virus that is not harmful to humans that carries the genetic code for one of the corona virus proteins.
The findings, published in the journal Lancet, did not come as a big surprise compared to the early data reported a few weeks ago in a press release on the third phase.
In light of the particularly alarming data, which included a dosing error in some of the subjects and an efficiency of about 60%, Astra-Zenika turned to a new channel, of further experimentation and collaboration with the Russian Gamalia Institute, based on the same technology, to develop a combined vaccine.
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Although the spotlight has been turned in recent weeks to the finalists Pfizer and Moderna, but as in any commercial race there are also losers, and stopping a clinical trial means a very significant economic loss.
Accordingly, the University of Queensland in Australia this week announced the halt to clinical trials of the vaccine it has developed with CSL.
Their vaccine is based on a classic recombinant vaccine technology, which contains proteins of the virus.
To stabilize these proteins, they were added short sections of protein derived from the HIV virus, which causes AIDS.
Unsurprisingly, participants in the first phase of clinical trials developed antibodies to these segments as well, and were therefore identified in tests as HIV carriers, although of course they were not infected with the virus, but only developed antibodies against it.
Although the results of the clinical trial were quite good, it was decided to abandon the trial because disrupting the effectiveness of HIV testing is a risk that should not be taken.
This is a significant loss for the university, but there is no reason to worry about CSL - they have already signed a contract with Astra-Zenica to produce 30 million vaccine doses.
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The fortunes of Snoopy and GSK, which are developing a recombinant vaccine together, have not improved either.
The vaccine is now in the second phase of clinical trials and the findings of the trials indicate relatively low efficacy in adults.
Therefore, it was decided to improve the vaccine - mainly to change the dose, and do another experiment.
The Chinese company Sinopharm, which is in the middle of the third phase, did not lick honey this week either.
Its vaccine was approved for emergency use in China in August, and more recently in the United Arab Emirates and Bahrain.
However, following a serious side effect found in a volunteer in Peru, the experiment was stopped until it became clear whether there was a connection between the phenomenon and the vaccine.
Information from the vaccination campaign from the UK is starting to flow.
One of the first vaccinators in the UK (Photo: Reuters)
In the meantime, information is already beginning to be received from the major vaccination campaigns that have begun in the countries that have approved the use of the Pfizer vaccine.
The switch to large-scale vaccines is also likely to reveal less common side effects of the trial.
In the UK, for example, two medical staff members lined up in an acute allergic reaction.
The two have a history of acute allergies and so the British have advised people suffering from acute allergies to avoid the vaccine for now.
In Alaska, too, one person had an allergic reaction after receiving the vaccine, but the details of the incident are not yet known.
In any case, this is a normal phenomenon: every vaccine has people here and there who are allergic to its components.
If there is an allergic reaction it appears quickly, so vaccinators are asked to stay in the clinic for at least 15 minutes after receiving the vaccine.
New and old actresses
This week another company began developing an RNA-based vaccine, similar to Pfizer and Moderna, the third phase of clinical trials.
The German company CureVac has started recruiting 35,000 volunteers in Europe and South America.
A large variety of vaccines will enable supply to many at cheaper prices and will accelerate the vaccination of the world population.
Russia this week announced the start of trials of a vaccine intended for animals, including minors.
Since the corona virus also infects animals, it is important to prevent farm animals from getting sick.
The fear is that the virus will undergo changes (mutations) in the animals' bodies and re-infect humans in its new form, as has indeed happened recently in Denmark.
This week's big news comes of course from the Modern Company vaccine that received the FDA's advisory committee recommendation on Thursday night.
The committee approved by a majority of 20 in favor and one abstention, the official approval is expected to arrive within a few days.
The vaccine will be given to people over the age of 18, of course not including pregnant women.
Two days earlier, the US Food and Drug Administration (FDA) published the findings of the clinical trials of the modern vaccine.
Similar to statements from the past month, the effectiveness of the vaccine appears to be high at 94.5 percent on average, and 86 percent over the age of 65. Side effects included injection site pain (91%), dizziness (68%), headaches (63%), muscle aches (60%), joint pain (45%) and chills (43%).
More serious, but not life-threatening, side effects appeared mainly in vaccinated people over the age of 65 and especially after receiving the second dose of vaccine.
The gap between the experimental group and the control group in the severe side effects was small, and not strong enough to prove a link between them and the vaccine.
During the experiment, one participant died of coronary heart disease, but he belonged to the control group, that is, he received a placebo vaccine.
Ness Ziona: Advanced Phase
Encouraging news in the Israeli arena as well.
The Biological Institute in Ness Ziona announced that the safety profile of the first phase was good, that there are no serious side effects to the Israeli vaccine and that they will start the second phase of the clinical trials in the coming days, for about a thousand participants.
Encouraging news in the Israeli arena.
The Biological Institute in Ness Ziona (Photo: Ministry of Defense)
In addition, Assuta Hospital in Ashdod has announced that volunteers who wish to do so will be able to open their trial file at any stage, and receive Pfizer's vaccine if it turns out that they were included in the control group, which received a sham vaccine. While this move will hurt the results of the experiment by deleting the control group, it seems that moral considerations have prevailed here.
Many countries around the world are currently grappling with this issue. It is very important to maintain a control group, so that there is a basis for comparison in case of rare or long-term side effects. On the other hand, there are tens of thousands of volunteers who have agreed to undergo an experimental medical procedure, and it would not be moral to abandon them to the dangers of the disease.
It seems that along the way, companies that begin the advanced stages of clinical trials will need to give the control group the most effective treatment available today, i.e. probably the Pfizer or Moderna vaccine. This is a common and accepted procedure in clinical trials, but also a considerable headache for companies.
To read a summary of the previous weeks in the scientific race to eradicate the corona
Dr. Erez Gerti is an immunologist at the Davidson Institute for Scientific Education
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