The AstraZeneca/Oxford COVID-19 vaccines being produced by the Serum Institute of India and SK Bio in South Korea were listed for emergency use by the World Health Organization (WHO) on Monday.

Emergency use listing (EUL), which involves experts assessing their safety, efficacy and quality, is a prerequisite for vaccines before they can be distributed by the global vaccine facility, COVAX. 

“Although the companies are producing the same vaccine, because there are many different production plants they require separate reviews and approvals,” WHO Director General, Dr Tedros Adhanom Ghebreyesus told the body’s biweekly pandemic media briefing.

“This listing was completed in just under four weeks from the time WHO received the full dossier from the manufacturers,” said Dr Tedros, adding that it was the second vaccine to get the WHO’s EUL after the Pfizer-BioNTech vaccine.

Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines, said there was now no need for countries to do bilateral deals with vaccine manufacturers as COVAX had already secured two billion vaccine doses and worked out their distribution, and the listing would “trigger a lot of purchase orders”.

“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk, contributing to the COVAX Facility’s goal of equitable vaccine distribution,” added Simão, who described the vaccine as easy to use as it can be kept in a normal fridge.

The Pfizer/BioNTech vaccine, which was giving EUL in December, needs to be kept in very cold storage of minus 70C.

China Team Summary Report Will be Based on Consensus

In response to news reports that indicated differences of opinion among the WHO expert group on the origin of the virus, which returned from China recently, WHO technical lead on COVID-19, Dr Maria van Kerkhove stressed that the team had not yet issued its report.

“The mission team from have recently returned from China and they are working on two reports. The first is a summary report just highlighting the work that has been done and some initial findings and recommendations, and then there will be a longer report. The idea would be that they would issue the summary report and then have a full press briefing themselves,” said Van Kerkhove.

Team leader Dr Peter Ben Embarek said that the summary report, expected in a matter of days, would be a “consensus report” reflecting  joint activities.

“The international teams and its Chinese counterparts have already agreed on the summary report when we were in Wuhan on the last day of mission, in particular, in terms of key conclusions, key findings, and key recommendations,” said Ben Embarek, adding that they were currently finalising the technical, background and methodological parts.

“The report will make recommendations for future long-term studies to explore some of the hypotheses and advance our understanding of the origin of the virus,” he added.

“Of course, the fact that we have different scientists with different backgrounds and different fields of experience, means that everybody has their specific views, specific recommendations, specific interest in moving some studies forward,” he said.

His comments came after Dominic Dwyer, an Australian infectious disease expert who was part of the international expert team, said the team had requested raw patient data from the Chinese but were only given a summary.

Dwyer told Reuters on Saturday that sharing anonymised raw data is “standard practice” for an outbreak investigation. He said raw data was particularly important in efforts to understand Covid-19 as only half of 174 initial cases had exposure to the now-shuttered market where the virus was initially detected. “That’s why we’ve persisted to ask for that,” Dwyer said. “Why that doesn’t happen, I couldn’t comment. Whether it’s political or time or it’s difficult.”

Dwyer also told the New York Times that the lack of access to detailed patient records from early confirmed cases, and possible ones before that, had prevented the team from nailing down when the first clusters of cases really emerged from Wuhan.

“We asked for that on a number of occasions and they gave us some of that, but not necessarily enough to do the sorts of analyses you would do,” said Dwyer.  The black spots are all the more troublesome because Chinese scientists have acknowledged that nearly 100 people were hospitalized in Wuhan as early as October 2019 with symptoms such as fever and coughing. Other international reports have also provided evidence of an uptake in hospitalizations overall in the autumn months – before the usual start of the flu season. Although the Chinese experts claims that these patients were not COVID cases – without detailed records that would be impossible to confirm.

The battle over the early cases is critical because it would be evidence that the virus originated in China. China has tried to promote a theory that the virus first infected people in Wuhan via imported frozen foods – something the WHO team agreed to investigate – even though key members are skeptical: “I think it started in China,” Dr. Dwyer said. “There is some evidence of circulation outside China, but it’s actually pretty light.”

A Danish epidemiologist on the team was also highly critical of the lack of Chinese transparency regarding the data, saying that the trip was. “If you are data focused, and if you are a professional,” said Thea Kølsen Fischer told the New York Times, then obtaining data is “like for a clinical doctor looking at the patient and seeing them by your own eyes.”  She added, “It was my take on the entire mission that it was highly geopolitical….Everybody knows how much pressure there is on China to be open to an investigation and also how much blame there might be associated with this.”

WHO Does Not Support Vaccine Passports at Present

Dr Michael Ryan, WHO executive director of emergencies, said that the emergency committee “does not advise the use of immunity certification as a prerequisite of travel” at this stage.

This was because “the vaccine is not widely available would actually tend to restrict travel more than permit travel” and there was not enough data to understand “to what extent vaccination will interrupt transmission”, particularly whether a vaccinated person can continue transmitting disease, said Ryan.

Once the vaccine is widely available and there is clarity about transmission dynamics, “disease vaccination passports can form part of a long term strategy for disease control and for the prevention of the disease potentially moving from one place to another, as we’ve seen with yellow fever vaccination requirements, which have been in place for a large number of decades now”, said Ryan. 

Ryan also cautioned that, although the global COVID-19 cases had decreased for the fifth consecutive week and were now at their lowest since last October, this could be the result of the natural patterns of the virus.

“I do think a good portion of that has been done to the huge efforts made by communities. There have been very stringent lockdowns and stay-at-home orders and other things, but also serum prevalence is rising. We need to understand what is driving those transmission dynamics. Is it natural seasonality and wave-like pattern of the disease? Are we building up a level of immunity in the population that’s preventing the disease from finding the next case? Are our control measures having an impact on that?’ asked Ryan.

He said that while all these factors were likely to hold some truth, the virus also had “a high force of infection” and it could “re-ignite and re-accelerate”. 

“It’s the accelerations in these in this disease that have been the most worrying,” said Ryan. “The disease can move along at fairly low levels and then you see this really fast acceleration and spread.

“We need to avoid that the next time, and we do believe that vaccines offer an opportunity to reduce the hospitalizations and deaths. ”

• Updated 16 February, 2021

Image Credits: AstraZeneca.