As the U.S., Europe and parts of Asia consume more booster doses than expected, global health advocates hope the emerging vaccine produced by Maryland-based Novavax will fill the supply gap in low- and middle-income countries in 2022.
But while Novavax — after partnering with India’s Serum Institute — obtained regulatory approvals from the World Health Organization and European Commission this month, crucial questions remain about both its ability to obtain Food and Drug Administration approval and to produce enough doses in manufacturing sites other than the Serum Institute.
The WHO set its goal in September after the world failed to meet its initial target of vaccinating 10 percent of every country by the end of September. But now, top officials in the Biden administration are increasingly fearful that the latest goal, as well, will be in jeopardy. The Biden administration has pledged 1 billion doses to the world in 2022, while COVAX, the global vaccine equity effort, is still waiting on other Western countries, including those in Europe, to pledge more doses for next year to help boost its stockpile. Meanwhile, COVAX and U.S. officials worry that as vaccine efficacy begins to wane, health officials in many nations will have to rejigger their calculations on how many doses are needed to increase protection at home.
In the meantime, however, Novavax has partnered with the Serum Institute in India, one of the world’s largest and most established manufacturing hubs. By December, both the WHO and the European Commission approved the Novavax-Serum Institute product for emergency use. The shot, which does not require freezer storage, is much easier to ship to Africa — where most countries lack 15 percent immunization rate — than the mRNA vaccines of Pfizer-BioNTech and Moderna.
So far, the company has only received approval for doses made at the Serum Institute because officials there delivered data that showed the manufacturing facility could produce a top notch product consistently and in large amounts. The U.S. and European sites are still working on proving they can do the same.
“In the near future, we will supplement our submissions with manufacturing data from additional facilities across our global supply chain and are confident that our clinical and manufacturing data meet the stringent standards set by all regulatory agencies around the world,” Trizzino said. The problem, global health advocates and Biden health officials said, is that the effectiveness of the vaccine is waning and the definition of fully vaccinated is being reconsidered. As Omicron continues to cause spikes in cases and hospitalizations in the U.S. and Europe, officials are beginning to recalculate how many doses they will need to protect their populations, meaning the 11 billion number could edge up in 2022.
Part of that investment was specifically geared toward helping the company find skilled workers who could help the company overcome its manufacturing snafus. But Novavax continued to struggle throughout 2021, missing benchmarks and targets it had publicly set for itself in 2020. COVAX has signed a deal with the Serum Institute to purchase 300 million doses of the vaccine made at its facility — supply the global vaccine distributor expects to be made available in the early days of 2022, according to a spokesperson from Gavi, the group helping finance COVAX. COVAX has also signed a deal with Novavax for 350 million of its doses that are to be manufactured at its European facilities.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Biden inks $137 mln contract to boost supply of key material for COVID tests -sourceThe Biden administration plans to announce on Wednesday a $137 million contract for Millipore Sigma, a unit of Germany's Merck KGaA , to boost production capacity of a highly constrained component of rapid coronavirus tests, a senior administration official told Reuters.
Read more »
Biden, Putin to speak Thursday amid growing tensions over UkraineThe administration said earlier this month that it was weighing sweeping sanctions against Russia if it invades Ukraine.
Read more »
'Serious' talk between Biden and Putin sets stage for diplomacyU.S. President Joe Biden and Russian President Vladimir Putin on Thursday exchanged warnings over Ukraine but conveyed some optimism that diplomatic talks in January could ease spiraling tensions.
Read more »
Biden pushes Putin for Ukraine de-escalation in second call this monthPresident Joe Biden urged his Russian counterpart, Vladimir Putin, on Thursday to take steps to ease an unremitting crisis on Russia's border with Ukraine, warning again of dire economic consequences should Putin proceed with an invasion.
Read more »
Biden administration defends its decision not to assert executive privilege over Trump's White House recordsBoth the House of Representatives and the Biden administration asked the Supreme Court on Thursday to deny former President Donald Trump's attempt to keep secret more than 700 pages of records that pertain to January 6.
Read more »
Biden, Putin to talk Thursday amid heightened tensions over UkraineRussian troops remain near Ukraine's borders, and bellicose rhetoric from Russian officials has Western officials on edge.
Read more »