• Moderna’s tech, J&J single-dose administration are selling points
  • Legal battle, side effects an obstacle for further AstraZeneca deals
  • Direct-to-manufacturer arrangement probable but limited rewards

Moderna and Johnson & Johnson still have opportunities to secure additional advance purchase agreements from the European Commission (EC) for their Covid-19 vaccines, but there are significant obstacles to doing so, pricing and reimbursement experts said. AstraZeneca, once expected to be one of the main vaccine players in Europe, is unlikely to secure further EC preorders moving forward due to existing issues with meeting its initial agreement, they added.

On 8 May, EU Commission President Ursula von der Leyen announced that it had secured a deal with Pfizer/BioNTech for 900 million doses of Comirnaty (BNT162b2) with an option for an additional 900 million up until 2023. Other contracts and other vaccine technologies will follow, she added. Moderna’s mRNA-1273, Johnson & Johnson’s (J&J’s) JNJ-78436735 and the University of Oxford/AstraZeneca’s Vaxzevria (AZD1222) are the three other vaccines authorised in Europe.

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mRNA-127’s similar technology to Comirnaty and JNJ-78436735’s single-dose administration support the likelihood that additional orders would be made for these vaccines, experts said. However, they noted, further contracts are unlikely to be the same magnitude as Comirnaty’s. The Pfizer/BioNTech deal is big enough to cover the EU population, and Moderna specifically may not have the same manufacturing muscle as Pfizer. Existing tension between the EC and AstraZeneca, with the latter not meeting existing arrangements, makes further deals unlikely, they added.

While the EC frowns upon member states ordering directly from manufacturers, such deals could still happen, especially if there are signs that Pfizer/BioNTech will have issues in meeting its contract, experts said. However, such a situation is unlikely unless there is immense public pressure and high appetite for boosters, they noted.

The EC has existing preorders with Curevac and Sanofi/GlaxoSmithKline, though their respective Covid-19 vaccines are still in development. These arrangements would still be fulfilled, but they would most likely be donated to developing nations, experts said. A J&J spokesperson said it is committed to continuing its collaborations and partnerships with governments including the EC, health authorities and other companies to help end the pandemic. The other aforementioned companies did not respond to a comment request.

Moderna and J&J can still carve out market share in Europe

Pfizer/BioNTech’s mega deal essentially locks in Comirnaty as the vaccine of choice for the EU. However, among the authorised vaccines in Europe, Moderna has the best shot at securing additional preorders from the EC as its mRNA-1273 shares the same vaccine technology as Comirnaty, experts said. Both mRNA vaccines have shown comparable efficacy.

Authorised adenovirus-vectored vaccines, on the other hand, such as Vaxzevria and JNJ-78436735 are associated with the rare but potentially serious side effect of thrombosis with thrombocytopenia syndrome (TTS), with the issue alarming the public on Covid-19 vaccine safety. TTS makes it unlikely for additional Vaxzevria orders, said Neil Grubert, independent global market access consultant, London, UK. JNJ-78436735, though, has the advantage of being a single-shot vaccine, and thus is more convenient than the two-dose mRNA vaccines and attractive to the EC over Vaxzevria, noted Stefan Walzer, CEO, MArS Market Access & Pricing Strategy, Baden-Württemberg, Germany.

EC’s initial preorders for Vaxzevria and JNJ-78436735 included 300 million and 200 million doses, respectively, with an option for another 100 million and 200 million shots. These deals were made before TTS concerns came to light. Prior to the Pfizer/BioNTech mega deal, the EC had pre-purchased 300 million doses of Comirnaty, followed by a second contract worth 300 million doses. The initial Moderna arrangement included 160 million jabs, followed by another deal for 150 million shots for delivery in 2H, with the option for 150 million more doses sometime in 2022. This equates to fully vaccinating 1.13 billion people; there are 447.7 million people in the EU. As of 12 May, 29.59% of people in the EU had received one dose of a Covid-19 vaccine, according to Our World in Data.

Based on experience from the initial round of Covid-19 vaccine deals, it is judicious to order more than what is needed for the population to factor for the possibility of manufacturers failing to deliver the agreed number of doses on time, experts noted. The EC and AstraZeneca are embroiled in a legal battle due to AstraZeneca’s delayed Vaxzevria shipments. The first lawsuit relates to AstraZeneca’s original contract to deliver 300 million doses by the end of June. The company has thus far shipped around 50 million shots, which should have been delivered in January. A second lawsuit is brewing, which could lead to fines for AstraZeneca.

The EC has not made new orders of Vaxzevria beyond June but has not ruled out renewal at a later stage, European Internal Market Commissioner Thierry Breton has said. But such delays for Vaxzevria make it unlikely for additional Vaxzevria deals, Grubert and Walzer agreed.

While experts noted that Moderna and J&J are likely to see additional contracts with the EC, they do not expect the deals to be as significant as the latest with Pfizer/BioNTech. The new 1.8-billion dose deal for Comirnaty is intended for use in adults, adolescents, and children, either as the first two doses or as boosters, which means fewer additional preorders from Moderna and J&J, noted Rafael de Wilde, senior executive advisor, Valid Insight, Antwerp, Belgium.

With the US becoming saturated with Covid-19 vaccine doses, Moderna is increasingly likely to consider courting the EC, noted Peter Hertzman, principal consultant, Health Access Agency, Zurich, Switzerland. However, Moderna may not have the manufacturing capability to match Pfizer/BioNTech, Walzer said. If Moderna and J&J can demonstrate increased capacity, then there would be an opportunity to pitch for more vaccine preorders, he added.

For Pfizer and BioNTech to fulfil their large EC order, it is possible they would lock in partnerships with other manufacturers, noted Andrew Mumford, managing director, Initiate, Northampton, UK. Merck and GlaxoSmithKline have faced development roadblocks with their own Covid-19 vaccines. They previously announced they would support manufacturing of JNJ-78436735 and Novavax’s NVX-CoV2373, respectively.

There is huge impetus for the EC to purchase vaccines made in the EU to avoid import issues, Mumford and Walzer said. Moderna vaccines are manufactured in Switzerland, which is not an EU member state, though fill and finish is done in Spain, while Comirnaty is made in Belgium and JNJ-78436735 in Italy.

Bespoke deals with countries possible but challenging to execute

If there are reports that Pfizer/BioNTech may not deliver agreed-upon doses on time or the EC has issues shipping doses to the individual member states, then individual EU countries could see this as a tipping point to directly order vaccines from the manufacturers, de Wilde said.

In fact, Hungary and Slovakia have authorised and ordered two million doses of Russia’s Sputnik V, despite the vaccine still being under EMA rolling review. Hungary also authorised and pre-purchased five million doses of the Chinese state-owned Sinopharm’s BBIBP-CorV, despite an EMA review yet to commence. These contracts were due to the slow initial rollout of vaccines, explained Caroline Conti, principal, Executive Insight, London, UK.

With a direct-to-manufacturer deal, member states could secure a specific number of vaccines from the EC, with the rest coming directly from a manufacturer, de Wilde added. While the EC discourages such agreements, the Commission cannot prevent them, noted Kuldeep Singh, global head, market access operations, Market Access Transformation, London, UK.

But there are many obstacles to direct-to-manufacturer arrangements, experts agreed, with Singh noting it depends on local politics. Compared with the first wave of vaccinations, boosters for all do not have the same level of urgency, Grubert added. Comirnaty booster deployment would not only depend on waning immunogenicity and protection data but also global supply and prevalence of variants of concern (VOCs), this news service reported on 10 May.

Also, Moderna may not be a large enough company to execute bespoke deals in individual countries, Conti added. Moderna has a market cap of $60.18bn, while AstraZeneca’s is £102.97bn ($114.99bn), J&J’s is $447.57bn, Pfizer’s is $223.68bn and BioNTech’s is $43.66bn. CureVac has a market cap of $19.10bn, while Sanofi’s is €108.97bn ($132.07bn) and GlaxoSmithKline’s is $96.70bn.

In the event that direct-to-manufacturer deals do happen, companies may ask for a higher price for countries to have first access, Grubert and Walzer said. Hungary paid EUR 30 per BBIBP-CorV dose and $19.90 for Sputnik V, 12 March news reports show. In a now-deleted tweet by Belgian budget state secretary Eva de Bleeker, the most the EU paid for its initial preorders is $18 per mRNA-1273 shot. A higher price for early vaccine access is a risky deal, as it would attract public scrutiny at home and abroad, experts agreed.

Before the Pfizer/BioNTech mega deal was announced, Pfizer had increased the cost of its vaccine from EUR 12 per dose to EUR 19.50 for the EC, according to 12 April news reports. This price hike was mainly due to Comirnaty having real-world effectiveness data supporting results from its clinical trials, Singh explained. If Comirnaty undergoes modifications before all preorders are fulfilled, such as improvements to tackle VOCs, this may command a 15–20% price increase for doses yet to be fulfilled, he added.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.