After signing agreements with Moderna and Pfizer, the Health Ministry is preparing for the logistical challenges posed by the vaccinations. How many will arrive? Where will they be stored? What difficulties are likely to be encountered and what about the testing of the Israeli vaccine? Haaretz explains.
Within a week, drug companies Moderna and Pfizer both announced impressive results of their testing of the vaccines they’d each developed against COVID-19, and the control center at the Health Ministry has already put together a team to prepare for their arrival. The team, headed by ministry deputy director-general Avi Ben Zaken, includes representatives of the HMOs, and delivery and logistics companies that specialize in transporting medical equipment, drugs and vaccines.
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Meanwhile, the pandemic response team has started to formulate recommendations for which groups should be vaccinated first. But even as Israel begins to take its first steps toward vaccinating the populace, there are a number open questions and possible difficulties en route.
Is the efficacy of the Moderna and Pfizer vaccines an established fact?
Not yet, and certainly not officially. The announcements made by both companies were based on interim findings of the third stage of their clinical trials. In Moderna’s trial, whose third stage included some 30,000 people, 95 people contracted the virus – five who had been vaccinated and 90 who had received a placebo. Of the 95 instances of infection, 11 people developed serious symptoms, and they were all members of the placebo group. According to these findings, the two-dose vaccine was 94.5 percent effective. In Pfizer’s trial, which included 44,000 people, 94 people became infected, making the effectiveness of its vaccine 90 percent.
Neither trial has been completed, however. Moreover, neither company has revealed the complete information about the trials; nor have the studies undergone peer review or been published in medical or scientific journals.
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The companies can only complete the regulatory and registration processes once the trials are complete, barring any surprises. The vaccines will be released only after the U.S. Food and Drug Administration approves them for use.
Pfizer, Moderna and the American authorities all have a vested interest in pushing the approvals through as quickly as possible, so the bureaucratic procedures will likely be expedited.
How does the vaccine work?
The vaccine uses messenger RNA (mRNA) technology. While some vaccines spark an immune response using parts of the pathogen itself – in this case the coronavirus – these vaccines do so by using mRNA nucleic acids. The mRNA gives instructions to the body's cells to produce the proteins that wake up the immune system and create protective antibodies. The advantage of this method is that it is much easier and faster to synthesize mRNA than the proteins of the virus.
How many vaccines will Pfizer and Moderna send to Israel, and when?
Pfizer is expected to manufacture 1.3 billion doses of the coronavirus vaccine next year. The details of the agreement with Israel were kept confidential, at the request of the company and for commercial reasons.
What has been publicly announced is that Israel will buy 8.5 million doses of the vaccine, which can inoculate 4.3 million Israelis (at two doses per person), for 800 million shekels (about $237 million).
Unofficial sources have reported that the vaccines will be supplied in several stages, with the first small batches set to arrive in January, and more arriving over time.
Moderna is expected to produce some 20 million doses by the end of this year to market in the United States, and in 2021 it will begin marketing between half a billion and a billion doses abroad. Health officials do not expect to see Moderna vaccines arriving in Israel before April.
The agreement between Israel and Moderna was signed in June and its details were kept confidential. According to various reports, Israel paid the company 238 million shekels, but it isn’t clear for how many doses. Based on that amount, however, the estimate is that Moderna will supply Israel with two million doses, enough for a million Israelis.
What logistical challenges are involved in getting the vaccine to Israel?
Pfizer’s vaccine is stored in deep freeze, at temperatures between -70 to -80 degrees Celsius, and it must stay at that temperature throughout its journey to Israel. According to health professionals, the weak spot of the vaccine supply is the transfer between different stages of transport from the U.S. factory to the Israeli HMO clinics at the end of the road. If the vaccine is kept for too long above the required temperature it could lose its potency.
According to sources familiar with the details of the deal, Pfizer’s vaccines would be flown to Israel, with the company responsible for the shipment until it reaches the airport in Israel, after which Israel assumes responsibility. Pfizer has yet to give Israel precise instructions on transporting and preserving the vaccines, how and how long to defrost them, and how long they can be used once they are defrosted.
Unlike Pfizer, Moderna says its vaccine can be stored at temperatures of between 2 and 8 degrees for up to a month, and up to six months if frozen at -20 degrees. In other words, it is expected to have a smoother delivery to Israel.
Is Israel prepared to transport the vaccines safely?
Israel knows how to transport vaccines and medical preparations at low temperatures. For example, polio vaccines must be transported at temperatures of -20 degrees. However, transporting Pfizer’s vaccines at -80 degrees is somewhat different and will require appropriate freezers. Israel has such freezers, but more will probably be necessary for all the required transportation.
Professionals familiar with the issue say the operation will not require large numbers of plans or trucks outfitted with special freezers. The vaccine bottles are relatively small – compared to flu vaccines, for example, which come preloaded in the syringe. The relatively small volume of the shipments will ease the process.
Where will the vaccines be stored?
Israel has yet to determine whether the vaccines will be stored by the Health Ministry or supplied directly to the HMO warehouses. The decision will depend on where the vaccines can be best protected, the amount of time needed to defrost them and how long they remain potent after defrosting.
Who decides who gets inoculated and when?
The pandemic response team is discussing its priorities for vaccination in various forums, but no official decision has been made.
Generally, people in high-risk groups and medical personnel are inoculated first, but the considerations are more complicated. Beyond determining who recieves the first 4.3 million doses (out of more than nine million Israelis), Israel must also determine the order of vaccination within these groups: Who gets the vaccine immediately and who must wait several weeks or months?
There are also questions regarding the safety of the vaccine for certain population groups. Is the vaccine safe and effective for people with underlying medical issues? And if so, for how long?
It must be noted that these vaccines were developed with unprecedented speed, compressing clinical trials that usually take years into only a few months.
Does the progress foreign companies have made on a vaccine make the Israeli effort to develop a vaccine superfluous?
Professional sources say no, stressing the advantage and importance of producing a coronavirus vaccine locally, especially if booster shots will be required every year or every few years.
Earlier this month, the Institute for Biological Research in Ness Ziona began clinical trials of its coronavirus vaccine, which are expected to last several months. The third stage will only begin in April, assuming the first two stages are successful, and it will include up to 30,000 volunteers. If that stage is successful, the vaccine can be approved.
What other difficulties may the vaccination campaign face?
Many people will be reluctant to be vaccinated due to concerns that the expedited approval may have compromised safety. In a study conducted in April by doctors at the Galilee Medical Center in Nahariya, the general public seemed more willing to be vaccinated than nurses, at a relative rate of 75 percent to 61 percent. Seventy-six percent of the people surveyed said they would be concerned about the vaccine’s safety.
Will the government obligate people to be vaccinated?
Sources in the health establishment say this won’t be necessary, certainly not in the coming year while the quantity of available vaccines will be limited.
If public willingness to take the vaccine is lower than expected, the Health Ministry prefers to roll out an information campaign encouraging people to get vaccinated rather than trying to pass legislation that could face many obstacles.