By Arno Schuetze
FRANKFURT (Reuters) -Germany's coronavirus vaccination campaign faced delays in several cities on Sunday after temperature trackers showed that about 1,000 of the shots made by BioNTech and Pfizer (NYSE:PFE) may not have been kept cold enough during transit.
"When reading the temperature loggers that were enclosed in the cool boxes, doubts arose about the compliance with the cold chain requirements," the district of Lichtenfels in the north of Germany's largest state, Bavaria, said in a statement.
Medical staff found that the temperature in one vaccine transport cool box had risen to 15 degrees Celsius, a spokesman for Lichtenfels said, above the maximum of 8C stipulated by the manufacturers. He added that his district had not received advice from BioNtech yet on how to proceed.
The regional government of Bavaria's Upper Franconia region where several affected districts are based said that BioNTech cleared the vaccines late on Sunday.
"BioNTech has confirmed the quality of the vaccine shots," a spokeswoman for Upper Franconia said. "The vaccination programme can start (in our region)."
BioNtech had earlier said in a statement it was responsible for the shipment to the 25 German distribution centres and that the federal states and local authorities were responsible for the shipment to the vaccination centres and the mobile vaccination teams.
"This is where the variations in temperature occurred. We are in contact with many authorities to provide advice, however it is up to them how to proceed", a BioNTech spokeswoman said.
In a December presentation, BioNtech had said that once removed from the freezer, the vaccine can be stored for up to five days at 2-8C and up to two hours at temperatures up to 30C, prior to use.
The vaccine, which uses new so-called mRNA technology, must be stored at ultra-low temperatures of about -70 degrees Celsius (-112°F) before being shipped to distribution centres in specially designed cool boxes filled with dry ice.
Once out of ultra-low temperature storage, the vaccine must be kept at 2C to 8C to remain effective for up to five days. The cool boxes designed by Pfizer are fitted with GPS trackers so the companies can deal with potential storage issues en route.
The spokesman for Lichtenfels said 1,000 shots had been affected by the temperature issue and that the city and the districts of Coburg, Kronach, Kulmbach, Hof, Bayreuth and Wunsiedel in northern Bavaria were waiting to hear from BioNTech about whether the vaccine could still be used.
"Vaccination against the coronavirus is not about who vaccinates the fastest or who does the most doses. Safety and conscientious work for the benefit of the population have the highest priority," said Oliver Baer, district administrator in Hof.
The European Union launched a mass COVID-19 vaccination drive on Sunday with pensioners and medics lining up to get the first shots to see off a pandemic that has crippled economies and claimed more than 1.7 million lives worldwide.
The delays in Germany highlight the challenge in rolling out the vaccine while regulators review for approval other shots, including those made by Moderna (NASDAQ:MRNA) and AstraZeneca (NASDAQ:AZN), which are easier to transport and store.
The roll-out of the Pfizer vaccine in the United States has been slow putting the government's target of 20 million vaccinations this month in doubt, as hospitals have navigated preparing the previously frozen shots for use, finding staff to run clinics and ensuring proper social distancing.
In Germany, similar temperature issues also delayed the start of the vaccination campaign in the southern Bavarian districts of Augsburg and Dillingen, where staff eventually got clearance from BioNTech to use the shots.
Germany's vaccination campaign officially kicked off on Sunday with residents of elderly care homes being inoculated. The federal government is planning to distribute more than 1.3 million doses to local health authorities by the end of this year and about 700,000 per week from January.