H1N1: Meeting the Challenge

The U.S. Responds

In early April, as part of a study aimed at improving flu surveillance, U.S. Centers for Disease Control and Prevention (CDC) scientists examine a flu virus sample collected in March from a child who visited a clinic in Southern California. They realize they’re looking at an unsubtypable influenza “A” virus not reported previously anywhere in the world.

On this same day, the first known death from a new strain of “swine” flu occurs in Oaxaca, Mexico.

CDC scientists suspect human-to-human transmission when they identify a child from a neighboring county with the same novel H1N1 virus. Neither child has had any contact with pigs. Several days later, the virus turns up in two children in Texas.

It’s clear that a multinational outbreak is in progress when preliminary lab results show respiratory viruses in Mexico are similar to H1N1 viruses in the U.S. Later in the month, New York City reports influenza-like illness in a cluster of schools.

With limited information about this new and potentially deadly flu strain, transparency is paramount and international cooperation is key. Days after identifying the new flu strains, CDC publishes its findings and holds press conferences to update the public and request reports of additional cases. The agency deploys its Global Outbreak Alert and Response Network to assist Mexico with its influenza investigation.

When HHS issues a nationwide public health emergency to mobilize against a flu pandemic, FDA takes immediate action, expanding emergency use of antivirals Tamiflu and Relenza, and authorizing emergency use of the first lab test to confirm the H1N1 virus and N95 masks for first-line responders.

The Department releases one-quarter of its federal antiviral drug stockpile—to be replenished later in the summer—to states and territories, and extends liability protection for these antiviral drugs to ensure they can reach the American people when they are needed .

HHS airs its first “Know What to Do About the Flu” webcast, to answer questions and provide information directly to the American people. “At times like these, clear and accurate information is one of the most powerful tools we have,” says HHS Secretary Kathleen Sebelius.

Vaccine Stage One

In May, every U.S. region is affected by the H1N1 virus. The number of cases in the U.S. reaches 1,000, and worldwide cases reach 10,000.

The virus is isolated and identified as a novel influenza virus. Preparation begins for development of a vaccine using conventional methods; a clinical sample of the virus is mixed with another influenza virus that grows in eggs to develop a new virus that has some of the properties of the novel virus and the ability to grow in eggs.

Public outreach continues. In his weekly address, the President discusses the government’s proactive response, from school closings to engaging online social networks. He recommends that individuals protect themselves, their families, and their communities by taking the same steps they would take to prevent the spread of any other flu.

The FDA and the FTC alert the public to be wary of fraudulent websites and other promotions for products that claim to treat or cure the 2009 H1N1 influenza virus.

WHO Declares Pandemic

The world sees its first pandemic declaration in over 40 years. The number of U.S. cases grows to 18,000, and the disease spreads to 74 countries.

The flu death toll around the world is up to 144. The World Health Organization (WHO) officially declares H1N1 to be a pandemic. “The virus is unstoppable,” says WHO director Margaret Chan.

Responding to the declaration, and after noting that WHO pandemic phases do not automatically imply high severity, HHS Secretary Kathleen Sebelius states: “What this declaration does do is remind the world that flu viruses like H1N1 need to be taken seriously…we need to start preparing now in order to be ready for a possible H1N1 immunization campaign starting in late September.”

Preparedness efforts are undertaken by all sectors – the government, the private sector, schools, and scientists. So far, the U.S. has not seen high numbers of severe cases, but that could change. It is unclear at this point how much the disease might spread.

The CDC updates guidance for business and pregnant women. Summer camp season arrives, prompting the CDC to release a podcast with tips to stay healthy and help prevent infection for children going to camp.

Clinical Trials

The summer months show signs of progress in vaccine testing and development. The first human vaccine trial is held  in Australia. Shortly after, in the United States, the National Institutes of Health (NIH) begins clinical trials that will eventually enroll thousands of healthy adults, children, pregnant women, people with asthma, and people infected with HIV.

The Obama Administration sends a strong message of “shared responsibility” at the H1N1 Influenza Preparedness Summit. The goal of the summit is to galvanize awareness and expand activities to include businesses, schools, etc.,  and to prepare for the fall flu season. HHS announces it will make available preparedness grants to state and local agencies worth a total of $350 million for resources and to step up their preparedness efforts.

All communications about H1N1 and seasonal flu are centralized on a new website: www.flu.gov. This one-stop comprehensive site brings together flu-related information from across HHS and other federal agencies.

HHS launches a new PSA campaign contest to encourage more Americans to get involved in the nation’s flu preparedness efforts by making a 15- or 30-second PSA. The idea of “shared responsibility” is stressed. The goal of the new HHS PSA campaign contest is to tap into the nation’s creativity to help educate Americans about how to plan for and prevent the spread of H1NI influenza.

We start see rising cases among students as they return to classrooms and dorms.

FDA Approval

In mid-September, the FDA announces approval of four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationwide.

NIH clinical trial results show the vaccine to be effective; a single dose of swine flu vaccine will protect healthy adults and older children from the H1N1 virus. Until now, many health officials feared it would take two doses. Early NIH trial results show, as expected, that only children 9 and under need two doses.

Secretary Sebelius receives her own seasonal flu vaccine at a local clinic in Alexandria, VA. She reminds all Americans to continue taking the necessary steps to protect themselves and their communities from the H1N1 and seasonal flu viruses.

The CDC launches a three-month text messaging campaign pilot to share important, timely health information directly to users.

The HHS PSA contest comes to a close when Dr. Clarke from New York wins with his PSA entitled “H1N1 Rap.” Dr. Clarke wins $2500 in cash, and his PSA is featured on national television.

Distribution Begins

As October begins, 26 states report widespread H1N1 flu activity.  By the end of the month, the number climbs to 46.  Visits to doctors for influenza-like illness increase nationally for the sixth consecutive week, and the number of lab-confirmed deaths in children and teens reaches 95.

Manufacturers inform CDC that 3 million doses of H1N1 nasal spray vaccine are ready for distribution two weeks ahead of schedule; CDC announces states can begin ordering vaccine the first week in October.  By the end of the month, 14.1 million doses are available for states to order.

HHS releases 300,000 bottles of Tamiflu® oral suspension for children from the Strategic National Stockpile.  FDA and CDC also issue guidance to pharmacists so they may use compounding to make liquid Tamiflu from syrup and Tamiflu capsules.

FDA allows Peramivir, an intravenous antiviral nearing the end of its approval cycle, to be used on an emergency basis, to treat flu in severely ill, hospitalized patients.  During October, FDA also authorizes three new lab tests to confirm H1N1 infection.

The President proactively declares an “H1N1 National Emergency,” to give states and hospitals the tools they will need to deal with an influenza surge.  The declaration allows Secretary Sebelius to consider “section 1135” waivers of the Social Security Act to authorize hospitals to establish satellite clinics and take other measures to handle a surge in use of medical facilities.

Secretary Sebelius and Assistant Secretary for Preparedness and Response Dr. Nicole Lurie testify before Congressional Committees on Homeland Security to ensure Congress is kept fully informed.

CDC recommends vaccination against bacterial pneumonia for high-risk individuals after pneumonia is found to have contributed to the deaths of 22 of 77 patients in an autopsy study.

FDA and FTC team up to bring public attention to web sites selling fraudulent flu products and shut them down.

Secretary Kathleen Sebelius hosts a second tabletop exercise for journalists, to help both government and media work together to get accurate, timely pandemic information to the American people. 

The Secretary also reaches out to African American media, with a conference call urging them to help protect their communities against H1H1 by encouraging people to get vaccinated. 

HHS launches new “Prevent the Flu” public service ads starring Elmo, Marc Anthony, Jackie Joyner-Kersee, Amy Ryan, and 5 of the top vote getters in HHS’s summer 2009 “What You Can Do about the Flu” contest. 

A new Flu.gov H1N1 Flu Self-Evaluation link goes live with information about what people can do to take care of themselves, what they can do to prevent the spread of the flu to other members of their families, and warning signs of flu symptoms that need the attention of a medical professional.

Priority: At-Risk Groups

At the beginning of November, the H1N1 virus is widespread in 48 states and continues to affect young people disproportionately.

About half of hospitalizations for flu-like illness and deaths from H1N1 are in people under the age of 24; by comparison, less than 10 percent of hospitalizations and deaths are among people over the age of 65.  The number of confirmed deaths from H1N1 or children and teens reaches 198.  However, CDC estimates that due to underreporting, the true number of children and teens who have died from H1N1 exceeds 500.

NIH research results show that pregnant women, another high priority group, mount a strong response with a single dose of vaccine.

With 35.6 million doses of H1N1 vaccine available in early November, the supply still falls short of vaccine manufacturers’ early predictions.  Nevertheless, doses continue to roll off production lines, and by mid-month 54 million doses are available for order.  CDC also begins to post a regular update of available doses on its website.

In mid-November, FDA approves the fifth and final 2009 H1N1 vaccine, and authorizes a vaccine already used successfully in adults for use in infants and children.

By the end of November, over 61 million doses are available for order just as reports of flu activity begin to decline in parts of the country.  This marks the beginning of a long-awaited window of opportunity to vaccinate more people and minimize the impact of a potential third wave of flu. 

In November, five HHS officials testify before House and Senate committees to update Congress on flu activity.

The Secretary participates in a ribbon-cutting at the Novartis cell-based vaccine plant in North Carolina, an important investment in new vaccine manufacturing technology, and part of the Administration’s commitment to the security and safety of the American people. 

FDA authorizes emergency use of two additional lab tests to confirm H1N1, and issues guidance for developing new H1N1 diagnostic tests.

The Secretary continues reaching out to providers, family organizations, and communities of color, speaking to conferences such as the American Association of Colleges of Nursing, Voices for America’s Children, and the National Council of La Raza throughout the month.  She also hosts a conference all with African American leaders and the leadership of Historically Black Colleges.  

Early in the month, flu.gov officially launches the national flu vaccine locator.  Now, anyone with access to the internet can go to flu.gov and find out where vaccine is available in his or her community. 

Toward month’s end, the Secretary hosts a webcast especially for bloggers, where she answers questions and enlists support in getting the word out about how important it for young people to get vaccinated.

NIAID reports that 446 people now follow its H1N1 announcements on Twitter.

Program Expansion

The number of states reporting widespread flu activity drops from 25 to 14.  Visits to doctors for influenza-like illness drop as do flu-associated hospitalizations.  As vaccine supply reaches almost 93 million doses and continues to increase steadily, states begin to extend their vaccination efforts to the general public.

However, flu-associated deaths continue to increase, serving as a reminder not only of the fact that flu can be deadly, but also of how important it is to vaccinate communities and reduce the impact of a possible winter outbreak.

HHS continues to place high priority on keeping the public up-to-date and informed about the full range of its pandemic response. 

The Department works closely with providers, who are stepping forward to dispel myths about vaccine safety and encourage the public to take advantage of the increase in vaccine supply.  In mid-December, the regular “What to Do About the Flu” webcast features a live discussion with the former president of the American Medical Association to answer providers’ questions about the 2009 H1N1 virus and vaccine.

Also during December, HHS and the Ad Council launch a new Together We Can All Fight the Flu PSA campaign to drive home the message that by getting vaccinated, you can help protect your whole community.  The Secretary continues to reach out to communities of color, where health disparities put many people at greater risk of flu complications.

NIAID and FDA lead an in-depth seminar for science writers on the range of new vaccine technology currently under development. 

The Department continues to be engaged in the international effort to stem the tide of H1N1 globally, sending Assistant Secretary for Preparedness and Response Lurie to the Global Health Security Initiative Ministerial Meeting in London. 

And, in a speech to the American Medical Association, Secretary Sebelius foreshadows next steps in the pandemic response, announcing a review of the Department’s entire public health countermeasures enterprise, to be completed in the first quarter of 2010.  “We’re going to look at how our policies affect every step of countermeasure development and production and ask: how can we do better?  And then we’re going to put those answers into action,” said Secretary Sebelius. 

Next Steps

Today, as 2009 comes to a close, close to 100 million doses of HINI influenza vaccine—and millions of doses of seasonal flu vaccine— have been produced in less than eight months. This is a record.

But it isn’t good enough. More must be done to strengthen our domestic vaccine production capacity in this country. This can be done by engaging on multiple fronts – by investing in the ground breaking work that the scientists at NIH and FDA are doing on the newest science and by working closely with the private sector through BARDA to expand the nation's production capacity in the short and long terms.

This response has successfully engaged the American people on the importance of vaccination. Demand is a positive sign. It shows that people not only understood that flu is serious, they also had confidence in this vaccine.

There is an unique window of opportunity right now. According the CDC, disease has gone down but flu is unpredictable and things could change on a dime. People are traveling for the holidays, they’re getting together with family, and there’s a lot of opportunity for the virus to spread. Many Americans have been patiently waiting their turn to get vaccinated and now is the time do so. There is enough vaccine in hand to help protect millions more Americans, because while the CDC predicts that about one of out six Americans has gotten H1N1, that means five out of six Americans hasn’t gotten it yet and needs protection.

Whatever hits this nation next and whatever crisis is around the corner, there is little doubt that this pandemic and this response have strengthened our public health system in this country. We can’t let that fade away. There is much left to do.