Boosters Dominate Covid Vaccine Discussion
In the highlights of last week, Germany’s CureVac withdrew its application to the European Medicines Agency for approval of its first-generation vaccine candidate, CVnCov, while US Merck applied to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its oral antiviral drug Molnupiravir.
Most of the vaccine discussion now centers on booster shots. On Oct. 14 and 15, the FDA’s vaccine advisory panel recommended that the agency approve Moderna’s and Johnson & Johnson’s respective third and second shots, with certain strings attached. The FDA itself has already fully approved the Pfizer/BioNTech booster for certain US population groups, including those over 65 and the immunocompromised. This is also the only vaccine to have received full marketing authorization from the FDA, although the European Medicines Agency has greenlit all three.
While the US national health authority normally nods off on its panel’s recommendations, the discussion of boosters has not proceeded smoothly up to now. Apart from the drugs czar's rejecting President Joe Biden’s plans to roll out third shots to the entire population, the scientists charged with the official decision were still divided early in the week. They dithered over whether recipients of the Moderna vaccine needed a booster at all and seemed somewhat uncertain about whether to recommend a second dose of the J&J jab – which is regarded as the weakest of the trio against Covid – or substitute one of the mRNA shots.
One Moderna dose contains 100 micrograms of mRNA – more than the Pfizer/BioNTech – and the FDA panel has recommended giving only half that, as per the US biotech’s application. As regards J&J’s product, the panel recommended a booster of any vaccine as a second dose for everyone 18 and over who received subsidiary Janssen’s vaccine – approved as a single-dose –, though some thought the wait should be longer. Some panel members said it should be a two-dose vaccine, anyway.
The advisory committee expressly did not recommend offering Moderna’s Spikevax to the age group 12 to 15, troubled by warning signals from five Scandinavian countries. Sweden, Denmark, Norway and Finland all have either banned or are discouraging young adults and teens from getting the Moderna vaccine because of the increased risk of the heart muscle inflammation known as myocarditis. The condition also has been observed in young men vaccinated with Pfizer/BioNTech’s Comirnaty, but Sweden’s national health agency said there was more safety data about the effects of this shot on children.
Scandinavia slams the brakes on Moderna shot
Restrictions in the Nordic countries vary. Health authorities in Finland and Sweden have banned Moderna’s shot for anyone under 30 and are recommending substitution of Pfizer/BioNTech, while Denmark is limiting Spikevax to those over 18. Instead of a ban, Norway is urging people under 30 to choose Pfizer rather than Moderna. Iceland has halted distribution of Moderna in general, and the country’s chief epidemiologist said deliveries will not be resumed until further information is obtained on the safety of the vaccine during the rollout.
Meanwhile, Israel, which up to now has administered only Comirnaty, is now planning to offer AstraZenca’s viral vector Covid vaccine to people who cannot receive an mRNA vaccine for medical reasons or who have experienced significant side effects after Pfizer, or in other special circumstances.
Side effects apart, Moderna has also been dodging blows on other fronts. Accused of not donating enough vaccine doses to developing countries and declining to license its vaccine to other drugmakers – something no vaccine maker has agreed to – it has now committed to deliver 1 billion doses of Spikevax to low-income countries in 2022. This is in addition to the 500 million it had already pledged to the global vaccine-sharing platform Covax.
The Massachusetts-based company has also faced flak from the White House for not contributing as many doses as Pfizer to meet the Biden administration’s commitment to donate to developing nations. The administration itself has been blasted for hoarding vaccines as boosters for its own population.
National news media recently quoted an anonymous member of Biden’s coronavirus task force as saying Moderna had accepted millions of dollars in US funding for its vaccine and had not provided enough in return. Some media suggested the company was only interested in its own bottom line. Pressure group Public Citizen was openly harsh, saying that Moderna “holds secret a vaccine recipe that humanity needs, a vaccine pioneered significantly by public science and developed in large part by billions in public money.” Even late-night TV comics jumped into the fray, with one joking that the government should seize the company’s formula and have the vaccines made by McDonalds.
To deflect the blows, Moderna has announced plans to invest up to $500 million in a new production facility somewhere in Africa that could turn out up to 500 million doses of its mRNA vaccine annually, although reports said it could take years before the facility was up and running.
"To date, more than 250 million people have been vaccinated globally with the Moderna Covid-19 vaccine. However, we recognize that access to vaccines continues to be a challenge in many parts of the world," CEO Stéphane Bancel said in a letter posted on the company's website.