BioNTech and Pfizer to begin clinical trial of vaccine for new Covid variants

BioNTech and Pfizer will start a clinical trial of a Covid-19 vaccine adapted to the BA.4 and BA.5 variants of Omicron this month, as the German biotech forecasts an increase in demand at the end of the year.

The company missed sales and earnings expectations in the second quarter after the European Commission renegotiated its Covid vaccine contract amid a glut of shots.

Second-quarter sales were €3.2bn, compared with the average analyst estimate for €4bn, and adjusted earnings per share were €6.87, below the consensus forecast for €7.27. Net profit in the period was €1.7bn.

However BioNTech reiterated its full guidance for annual revenues between €13bn and €17bn, because doses scheduled for delivery in the second and early in the third quarter will now be distributed later in the third and fourth quarters.

BioNTech’s chief executive Uğur Şahin said the company was expanding its Covid product pipeline, aiming for “prolonged and broad protection”.

BioNTech has been manufacturing doses of its first Omicron vaccine — targeted at BA. 1 — since the spring and is ready to deliver whenever it is approved by a regulator. The company expects to be able to start delivering shots targeted at BA.4 and BA.5 as early as October, if it receives regulatory approval.

Özlem Türeci, chief medical officer, said data from studies in mice — which has previously been predictive — showed the shot targeted at BA.4 and BA.5 elicited a stronger immune response against those variants, and all other subvariants of Omicron. She said this data, combined with their extensive experience and data from prior Covid-19 vaccines, may be sufficient for emergency approval, and enable a “timely response”.

Regulators are trying to balance the need to keep up with new variants by using the most up-to-date vaccine available, with a desire to ensure confidence in the safety and efficacy of the shots.

The European Medicines Agency will require clinical data for a shot targeted to BA.4 and BA. 5, whereas the US Food and Drug Administration has said it would be prepared to approve the shot while trials are ongoing. Emer Cooke, head of the EMA, told the Financial Times that her agency would stick to the need for trial data before an approval, saying “promises are not enough for me”.

BioNTech is investing much of its share of the proceeds from the Covid vaccine into work it hopes will transform the treatment of cancer. The company forecasts it will spend between €1.4bn and €1.5bn on research and development this year. It recently received positive data from an early stage trial of a personalised cancer vaccine for pancreatic cancer, as well as its novel CAR-T cell therapy candidate in solid tumours.

It also plans to use some cash for acquisitions. Ryan Richardson, chief strategy officer, said BioNTech expects to do deals in the second half. “We are currently evaluating a wide range of opportunities, which can complement and expand both our pipeline and technology toolkit,” he said.

BioNTech’s chief financial officer Jens Holstein said the company remains focused on “furthering our oncology pipeline as well as driving our leadership in Covid-19 vaccine development”.

“We are driving toward potential launches of multiple innovative products to address diseases with high unmet medical need in the coming three to five years,” he said.