As SARS-CoV-2, the causative agent for COVID-19, continues to cause rampant destruction on human lives globally, biopharma companies are stepping up their game to provide some relief. The latest one to have a vaccine almost ready to hit the market is Johnson and Johnson (J&J). This biopharma giant is being hailed as the gamechanger with their single-dose vaccine as COVID-19 cases keep mounting globally.
Johnson & Johnson’s Vaccine
J&J’s candidate Ad26.COV2.S is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector capable of encoding a full-length and stabilized SARS-CoV-2 spike protein. In the Phase 1/2a trial, the vaccine was administered to people within 18 years – 55 years and 65 years or older with a randomized distribution of two specific doses. Data published in The New England Journal of Medicine shows that the vaccine demonstrated that the antibody response continued to remain strong, even improving up to 71 days after the first dose was administered. This trend was also observed in adults over 65 years, which scientists say is extremely encouraging. Adverse events included pain at the injection site, nausea, among others . At the JP Morgan conference, J&J’s CEO said that he expects the data from the Phase 3 trial to arrive ‘very soon.’
Positioning in the Market
Although J&J’s candidate didn’t beat the mRNA vaccines from Pfizer and Moderna to the market, it is still expected to play a significant role in alleviating COVID-19 cases globally. The vaccines from Pfizer with BioNTech and Moderna, already approved by the US Food and Drug Administration (FDA), have found their way onto the arms of many Americans in the last month or so.
However, both these vaccines are deemed to be only effective if a person is receiving two inoculation doses spaced out within a few weeks. This is challenging, as, in such unprecedented times, both companies face tremendous logistic supply chain issues, shortage in doses available for rapid inoculation, and adopted policies by the government to hold off doses. Of the 20 million doses received in the US, only 7 million have been administered as of January 11th. All this has led to a startlingly slow start to the vaccination drive as the clock keeps ticking and more lives are lost by the hour.
J&J intends to revolutionize this by administering a single dose instead of the two as required by other companies. This will help more people to get vaccinated quickly and provide a much-needed break to humanity. Additionally, the vaccines can be maintained at refrigerated temperatures while transporting, which is a huge advantage as both Moderna and Pfizer require various degrees of freezing.
Initially, J&J intends to produce an initial 900 million doses of the vaccine, plus a potential further 400 million doses under option. However, the company seems to have encountered a snag in their manufacturing, with productions unlikely to reach peak volumes before April-May. Based on their upcoming Phase 3 trial data, J&J intends to gain authorization from the federal body by the first half of 2021. Other companies vying for an early 2021 approval in the US include Novavax and AstraZeneca, with Novavax already capable of producing approximately 2 billion doses of their vaccine yearly. With so many pharmaceutical companies looking to bring forth their vaccines into the market, people hopefully will be able to get out and about their normal lives soon.
By T. Chakraborty, Ph.D.
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