Covid vaccine: Why Novavax's approval process is getting delayed

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Covid vaccine: Why Novavax's approval process is getting delayed

 Covid vaccine: Why Novavax's approval process is getting delayed
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Summary 

  • Novavax Inc announced that it would delay its application for emergency use authorisation to FDA until Q4.
  • The company said it has filled for regulatory authorisation in India, Indonesia and the Philippines.
  • The share prices of the Novavax Inc dropped by 12% in after-market trading following the announcement.

US biotechnology company Novavax Inc recently said it would delay its plea for US emergency use authorization for its Covid-19 jab by at Q4 2021 as it is struggling with collating consistent manufacturing information to given to be officials. The company had previously said it would seek emergency use authorization from the US FDA in the Q3 2021.

Stanley Erck, Chief Executive of Novavax, said that the company is getting all information regarding manufacturing analytics, potency and purity assays in line. As the process is time consuming, the approval procedure is getting delayed. By October, the company plans to go to the FDA, but nothing has been finalized yet.

He added that in September Novavax plans to seek approval from the UK regulators, followed by Canada and Australia.

Novavax Inc share prices slipped by 12% in after-market trading following the announcement.

Also read: Why have Pfizer and Moderna raised prices for vaccines in the EU?

Previously, the biotech major was praised for its efforts in manufacturing vaccine,  as it scored over other competitors because its jabs can be easily stored at normal refrigerator temperatures, which is a big advantage and will help meet the global demand for Covid-19 vaccines. However, the company has not received approval from any medical authority yet. As per news reports, the protein based Novavax vaccine is 90% effective in preventing the disease, according to study of nearly 30,000 people in the US and Mexico conducted in June 2021. Most participants reported mild side effects.

If given an approval, the jab would help in the vaccination efforts in lower income countries. Many countries have reported shortage in vaccine availability, highlighting the growing disparity between developed and developing countries.  

Also read: COVID-19 is resurging: How effective can vaccines be?

The company has delayed its plan to request authorization for emergency use several times as it has a traditional way of doing a potency assay, which takes time that can be used in the filing. There’s a second-generation version of this, which they are working on with the FDA that’s not validated yet. The company is also facing challenges in term of ramping up its production capabilities amid raw-material shortages.

Assays are the tests carried out to determine the quality and effect of a drug. The company needs to validate its manufacturing processes and generate data from manufacturing partners to show regulators that their production processes are standardised in all its facilities. 

In addition to this, the company has also filed for regulatory nods in India, Indonesia, and Philippines for its Covid-19 vaccine. It is also said that it would be offering vaccines to some low-income countries. Novavax has partnered with the Serum Institute of India to manufacture vaccines for three countries. The biotech major would be seeking WHO’s permission in August for its emergency listing for global use.

The company has reported a US $352m loss in the Q2 2021, which was reported $18m loss in first quarter of the year, which was below analyst expectations. Its second- quarter revenue stood at US $298 million.

The Wall Street analysts had expected negative US $3.63 earnings per share, rather than the negative US $4.75 as reported.

Third dose push

The company released a booster data showing that a third booster of its vaccine administered six months after an initial two-dose regimen it increases neutralizing antibodies by 4.6 times compared to the initial vaccine regimen.

ALSO READ: COVID-19 vaccine booster shots: do we really need them?

Novavax also relieved that cross-reactive antibody against the Delta variant increased six times compared to the primary vaccine series. Studies are conducted to see if it can be used as a booster for other Covid-19 vaccines.

Plans are afoot that it would approach the US FDA for a separate consent for its booster shot. Other manufacturers such as, Pfizer Inc. have plans to ask for the booster dose approval later this month.

The company reported that it is on the way to be able to produce vaccines at a monthly capacity of 100 million doses by the end of Q3 and around 150 million doses by 2021-end.

Earlier this week, Novavax had agreed to a deal with the European Commission for the purchase of up to 200 million doses for its citizens. The company would start delivering the jabs after the regulators give a go-ahead to their vaccine.

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