WHO: several hundred thousand Ebola vaccine doses expected by mid-2015

Ebola vaccine trials are to start in west Africa in December, a month earlier than planned, and hundreds of thousands of doses will be available by mid-2015, the World Health Organisation says.

A high-level meeting of government representatives, including donor countries and those affected, together with vaccine manufacturers, has decided to push ahead with unprecedented speed, even though the early data on safety and the immune system response to the vaccines will not all be in.

The first vaccinations of health workers and others at high risk, including burial teams, are likely to take place in Liberia, with Sierra Leone not far behind. In the Liberian trial, the vaccines will be tested against placebo – some health workers will get the Ebola shot, while others will be given a vaccine that is protective against another disease, such as measles. The selection will be random and blinded, so that neither volunteers nor doctors know who has been given which vaccine until the trial ends.

The trial design has been drawn up by the United States, which wants to satisfy the requirements of the Food and Drug Administration (FDA), which licenses vaccines.

The idea of testing against placebo in the Ebola outbreak has been controversial, but it has the advantage of providing a definite result more rapidly, which would be for the good of the general community, said WHO assistant director general Dr Marie Paule Kieny. The trial in Sierra Leone will not be against placebo.

The safety trials currently taking place in the UK, US and Mali and starting in Switzerland, Germany, Gabon and Kenya will enable scientists to work out the correct dose of vaccine needed, ensure there are no serious side-effects and see whether antibodies to fight the virus are generated in the blood. The results will still be coming in as the first Liberian health workers are vaccinated. “As we accelerate in a matter of weeks a process that typically takes years, we are ensuring that safety remains a top priority with production speed and capacity a close second,” said Kieny.

“Vaccines are not the magic bullet, but when ready, they may be a good part of the effort to turn the tide of the epidemic.”

The first two vaccines to go into frontline trials will be those made by GlaxoSmithKline (GSK) and Johnson & Johnson, but five more will be tested as they become ready. Manufacturers have promised that larger quantities of vaccines will be available than previously thought. “The companies have committed to ramp up to millions of doses to be available in 2015, with hundreds of thousands ready in the first half of the year,” she said. Mass vaccination – if any of the vaccines work – will not happen before next June at the earliest, she added.

Last week, GSK’s Dr Ripley Ballou said any vaccine that was developed would come too late for the current epidemic. But hurdles are being leaped in an unprecedented fashion, with regulatory agencies and ethics committees moving at extraordinary speed and funding questions simply waved away.

“There is a broad understanding that money will not be an issue for this Ebola vaccine,” said Kieny. Governments and international agencies are expected to pick up the bills, which include the provision of storage at very low temperature.

Médecins Sans Frontières (MSF), whose volunteer doctors have already treated thousands of patients in west Africa, welcomed the WHO’s acceleration of the vaccine trials.

“It is crucial that people from ministries of health, aid agencies and communities who are holding the response to the epidemic together, and ensuring access to essential healthcare, are protected,” said Dr Bertrand Draguez, medical director for MSF.

“Resources everywhere are stretched to almost breaking point; everyone is at capacity, but it is extremely hard for the people treating and sustaining the response to do it with absolutely no safety net. Safe and effective treatments and vaccines could offer just that.”

More money for the fight against Ebola was promised on Friday. European leaders responded to an appeal from David Cameron with a pledge of €1bn (£800m). “If we do not significantly step up our collective response now, the loss of life and damage to the political, economic and social fabric of the region will be substantial and the threat posed to our citizens will also grow,” he wrote to the president of the European council, Herman Van Rompuy, last week. The UK has put in an extra £80m to raise its own contribution to £205m.