Novavax targets May approval for COVID-19 vaccine in the U.S.


Every human life is precious and sacred. One who saves a life it is as if he or she has saved the whole of humanity. (Al Quran 5:32/33)

Source: Fierce Biotech

By Nick Paul Taylor | Mar 2, 2021 8:05am

Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year.

The success of the vaccine in a 15,000-subject U.K. phase 3 clinical trial gives Novavax a clear path to a positive decision by the Medicines and Healthcare products Regulatory Agency (MHRA). However, the lack of data from another phase 3 trial that only recently completed enrolling 30,000 subjects in the U.S. and Mexico makes the route to a FDA OK less clear.

Discussions with the FDA are continuing, but the “hope and expectation is that the FDA will agree to review the U.K. data,” Novavax CEO Stanley Erck told CNBC. If FDA agrees to review the U.K. data, the vaccine could receive emergency use authorization in the U.S. in May.

Novavax will need to wait longer if the FDA requires the inclusion of data from the U.S.-Mexico trial. Erck said it will be “a couple of months” before final data are available from that trial, suggesting that waiting on those results would push authorization in the U.S. back to the second half of the year.

AstraZeneca won authorizations in some markets on the strength of data generated in Brazil, South Africa and the U.K. but is waiting on U.S. data before seeking FDA approval. However, the University of Oxford-sponsored studies that supported AstraZeneca’s ex-U.S. authorizations have been subject to criticisms not leveled at the Novavax trial.

Whatever happens with the FDA, Novavax is likely to receive authorization in parts of the world in the next few months. Erck expects to have completed a rolling submission to the MHRA by the end of the month. Based on how quickly the MHRA reviewed other vaccines, the timeline suggests Novavax could get clearance to sell its vaccine in the U.K. in April. Rolling reviews in Australia, Canada, the EU and New Zealand are also underway. 

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Categories: Vaccine

6 replies

  1. CEO Stanley Erck has been busy expanding manufacturing capacity for several countries, and expects the U.K.’s regulatory body to grant authorization in a matter of weeks. Erck said he is ready to roll out vaccines not just in the U.K., but also in Australia and Canada, as the two will accept the U.K. green light as a signal the vaccine is safe to use.

    “Many regulatory agencies are going to be inclined to follow the [Medicines and Healthcare products Regulatory Agency] very shortly,” Erck said.

    But what will happen in the U.S. market remains unclear. Erck has made no secret about his hopes that the U.S. Food and Drug Administration (FDA) will grant an EUA based on the U.K. data — which showed the vaccine was 89.7% efficacious in the U.K., which is dominated by the B.1.1.7 variant, and 96% efficacious against the original virus strain.

    Novavax's COVID-19 candidate vaccine NVX-CoV2373 is administered to a health volunteer. –
    Novavax’s COVID-19 candidate vaccine NVX-CoV2373 is administered to a health volunteer. –
    Erck told Yahoo Finance Monday that it is clear now the FDA will use the data from the Phase 3 trial in the U.K. and Phase 2b trial in South Africa as part of its decision.

    “It’s clear that they will use the U.K. and South Africa data as part of their decision process. What’s not clear is whether we also need the U.S. data,” Erck said.

    The U.S. Phase 3 trial is already fully enrolled and has already begun to count cases — a metric used to determine when to end the trial. Erck said based on how many cases are being counted, the trial could end “earlier than we originally thought. So those data could be available without terrible delay.”

    Meanwhile, the company is already busy scaling up production between now and expects to reach an output target of 150 million doses per month by summer. The company has relied on partners like the Serum Institute of India and Takeda (TAK), in Japan, to help it produce doses in addition to eight plants.

  2. (CNN) The White House is racing to prevent and prepare for a potential fourth coronavirus surge as more transmissible coronavirus variants spread across the US — investing billions of dollars to boost coronavirus preparedness, accelerating the pace of vaccinations and working to prepare the public and governors for the prospect of another surge.

    In what would be a first, the White House is drawing up plans to surge vaccines to emerging hotspots in an attempt to blunt the virus’ trajectory and protect those at highest risk, two senior administration officials told CNN.

    While the number of daily coronavirus cases continues to decline and more than 2 million Americans are now being vaccinated daily, the White House Covid-19 response team has been preparing for the worst. Officials have been combing through data to plot the virus’s trajectory, mapping out different scenarios and drawing up plans for how the federal government would snap into action.

    Analysis: Biden scored a major legislative victory, but now comes the hard part
    Biden commits to ‘free, open, secure’ Indo-Pacific in rare op-ed with ‘Quad’ members
    “Everything we do is with the thought in mind that there might be another surge,” a senior administration official said, summing up the administration’s efforts to combat the virus and prepare for a surge.

  3. Coronavirus vaccines tweaked to deal with variants will be fast-tracked without compromising on safety or effectiveness, the UK’s regulator has said.

    The approach will be similar to the regulatory process for the modified flu vaccine, to deal with new strains each year, with a brand new approval not required.

    Scientists have previously said a COVID-19 variant resistant to the current crop of vaccines is likely to emerge at some point, but vaccines can also be adapted quickly.

    The guidance states coronavirus vaccine manufacturers will need to provide robust evidence that the modified shot produces an immune response. However, lengthy clinical studies deemed not to add to the regulatory understanding of their safety, quality or effectiveness will not be needed.

    The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) said researchers are in a better position to measure protection by looking at antibodies in the blood after vaccination, reducing the need to wait and see whether people in a trial become infected with the virus.

  4. Vaccine safety experts from the World Health Organization (WHO) are meeting on Tuesday to review the Oxford-AstraZeneca jab, after several European countries halted their rollouts.

    A number of cases of blood clots were reported in Europe after the vaccine was administered.

    But the numbers are below the level you would expect in the general population.

    The UK medicines regulator and the WHO say there is no evidence of a link between the vaccine and clots.

    The European Medicines Agency (EMA) – the European Union’s medicines regulator – is also meeting on Tuesday.

    It is expected to issue its decision on the continued use of the Oxford-AstraZeneca vaccination on Thursday.

    About 17 million people in the EU and the UK have received a dose of the vaccine, with fewer than 40 cases of blood clots reported as of last week, AstraZeneca said.

  5. By Francesco Guarascio and Carl O’Donnell

    BRUSSELS (Reuters) – Novavax is delaying signing a contract to supply its COVID-19 vaccine to the European Union, an EU official involved in the talks told Reuters, as the U.S. biotech company warned it was struggling to source some raw materials.

    Prolonging the talks might further complicate the EU’s vaccination plans as the bloc had planned to sign a deal early this year for at least 100 million doses of Novavax’s vaccine, with an option for another 100 million.

    The EU official, who asked not to named as the talks are confidential, said the company had postponed signing a deal for weeks, citing legal issues in meetings with the bloc’s vaccine negotiators.

    “They are slowing down the process of finishing the contract,” the official, who attended the meetings, told Reuters.

    Informally, a Novavax executive had said a slow pace in negotiations was warranted because the company was having production problems, the EU official said.

    A Novavax spokeswoman said in an email that talks with the EU over a supply deal continue, but declined to say more about the discussions.

    She said the company was working “through some pandemic-related raw materials supply shortages”, without giving details.

    The European Commission, which coordinates talks with vaccine makers, declined to comment.

    Facing supply problems from other COVID-19 vaccine makers, notably AstraZeneca, the EU’s immunisation campaign is lagging far behind those in the United States and Britain, a situation that has become more critical as a third wave of infections sweeps the bloc.

    Novavax is planning to produce key components of its two-dose vaccines for the EU in several of its factories, it said, including one in the Czech Republic, which makes antigens, the inactivated organisms that trigger an immune response.

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