After Pfizer and BioNTech scored the FDA’s emergency use authorization for their mRNA-based Covid-19 shot late last week, hopes are high that one or more vaccines could turn the tide on the pandemic. But vaccines will take time to get into arms, and a former FDA head is calling on drugmakers to double down on making antibody therapies as a “Covid insurance policy” in the meantime.
In a Wall Street Journal column penned less than 48 hours after Pfizer-BioNTech’s EUA, former FDA commish Scott Gottlieb opined that manufacturers have not invested enough resources into stockpiling antibody therapies — especially from Regeneron and Eli Lilly, which have already received EUAs of their own — as a crucial backstop in the US pandemic response.
The solution? Contact biopharma manufacturing plants to switch gears and produce large quantities of the Regeneron and Lilly drugs. This, Gottlieb said, was always the best option in his mind to reduce the impact of the virus while a vaccine was slowly rolled out to the masses.
“Supply is severely constrained, and the two available drugs must be rationed, somewhat arbitrarily, because the government didn’t do everything possible last spring to ramp up manufacturing,” Gottlieb wrote. “There is still an opportunity to invest in making more antibodies … there will be many patients who need these medicines.”
Gottlieb laid out what would be a complicated process for how the Regeneron and Eli Lilly antibody drugs could be produced at a much greater scale than the 6 to 7 million doses available next year. It would require widespread licensing and tech transfer for both therapies but could help the US be better prepared for a harsh winter in 2021.
First, large manufacturing plants can dip in to their reserves of other drugs already on hand, which normally amounts to at least two years worth of supply. This will avoid creating a shortage of other important medicines while the facilities switch gears to producing Covid-19 antibodies.
While it would take around six months for a manufacturer to fully switch mechanisms to produce the Regeneron or Eli Lilly drug, doing so could produce as many as 2.5 million doses in eight months, Gottlieb said. The government would then agree to buy the antibody and stockpile it at a worthwhile price for the manufacturer, and Regeneron or Eli Lilly would be paid to license the drug.
The US government would do well to invest in such a plan, Gottlieb wrote, because it could freeze some of the active pharmaceutical ingredient and store it away as a hedge against another tough winter. Making the active ingredient is the hard part, Gottlieb said, but that API could stay frozen for three years. Thawing it and turning it into finished drug would take less than a month.
While a version of this plan has already taken place to get to the current antibody drug capacity of 6 to 7 million doses — Amgen teamed up with Eli Lilly, and Roche worked with Regeneron — Gottlieb said that much greater stockpiles will be needed over the coming months.
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